Skip to main content
Top
Published in: BMC Musculoskeletal Disorders 1/2016

Open Access 01-12-2016 | Study protocol

Effect of aqua-cycling on pain and physical functioning compared with usual care in patients with knee osteoarthritis: study protocol of a randomised controlled trial

Authors: Stefanie Rewald, Ilse Mesters, A. F. Lenssen, Pieter J. Emans, Wiel Wijnen, Rob A. de Bie

Published in: BMC Musculoskeletal Disorders | Issue 1/2016

Login to get access

Abstract

Background

Over the last decade aquatic exercise has become more and more popular. One of the latest trends is aqua-cycling, where participants sit on a water-resistant stationary bike and, while immersed chest deep in the water, combine continuous cycling with upper body exercises that utilise water resistance. Since stationary cycling and aquatic exercises are frequently recommended to patients with knee osteoarthritis, combining both would seem an obvious step, and an aqua-cycling exercise programme for patients with knee osteoarthritis has indeed been developed. This study protocol gives a detailed description of the exercise programme and the methodology of a study to compare this programme with treatment involving usual care only.

Methods

The study is a single-blind, parallel-group, randomised controlled trial of Maastricht University Medical Centre+, the Netherlands. Inclusion criteria: knee pain of four to seven on a 10-point pain rating scale; a Kellgren/Lawrence score between one to three; ability to cycle; good mental health; sufficient language skills; indication for physical therapy in conjunction with impairments due to OA. Exclusion criteria: any contra-indication for aquatic exercise; planned total knee replacement; corticosteroid injection <3 months and/or hyaluronic acid injection <6 months; severe joint complaints (other than knee joint); symptomatic and radiological apparent hip OA; inflammatory joint diseases; inability to safely enter and exit the pool; fear of water. Participants will receive two 45-min moderate intense aqua-cycling sessions weekly over a period of 12 weeks in addition to usual care or usual care only. Usual care consists of an individual intervention plan comprising lifestyle recommendations, medication routine and referral to a physical therapist. Participants will be assessed at baseline, and at 12 and 24 weeks after baseline. The primary outcome is self-reported knee pain and physical functioning. Secondary outcomes are lower limb muscle strength, functional capacity, self-reported disease severity, physical activity level, quality of life, self-efficacy and fear of movement. Daily diaries will collect information on knee pain, physical functioning, level of physical activity, pain medication routine and physical therapy (control group only) or exercise participation over two 30-day periods (during the intervention period).

Discussion

To our knowledge the present study is the first randomised controlled trial evaluating the effects of aqua-cycling in the pre-surgical stage of knee osteoarthritis. This trial will demonstrate if the newly designed aqua-cycling intervention, in supplement to usual care, can help to improve impairments due to knee osteoarthritis.

Trial registration

Netherlands Trial Register NTR3766 (21-12-2012).
Appendix
Available only for authorised users
Literature
2.
go back to reference Dreinhofer K, Stucki G, Ewert T, Huber E, Ebenbichler G, Gutenbrunner C, et al. ICF Core Sets for osteoarthritis. J Rehabil Med. 2004;36 Suppl 44:75–80. Dreinhofer K, Stucki G, Ewert T, Huber E, Ebenbichler G, Gutenbrunner C, et al. ICF Core Sets for osteoarthritis. J Rehabil Med. 2004;36 Suppl 44:75–80.
3.
go back to reference Pisters MF, Veenhof C, van Dijk GM, Dekker J. Avoidance of activity and limitations in activities in patients with osteoarthritis of the hip or knee: a 5 year follow-up study on the mediating role of reduced muscle strength. Osteoarthritis Cartilage. 2014;22:171–7.CrossRefPubMed Pisters MF, Veenhof C, van Dijk GM, Dekker J. Avoidance of activity and limitations in activities in patients with osteoarthritis of the hip or knee: a 5 year follow-up study on the mediating role of reduced muscle strength. Osteoarthritis Cartilage. 2014;22:171–7.CrossRefPubMed
4.
go back to reference Holla JF, van der Leeden M, Knol DL, Roorda LD, Hilberdink WK, Lems WF, et al. Predictors and outcome of pain-related avoidance of activities in persons with early symptomatic knee osteoarthritis: a five-year followup study. Arthritis Care Res. 2015;67:48–57.CrossRef Holla JF, van der Leeden M, Knol DL, Roorda LD, Hilberdink WK, Lems WF, et al. Predictors and outcome of pain-related avoidance of activities in persons with early symptomatic knee osteoarthritis: a five-year followup study. Arthritis Care Res. 2015;67:48–57.CrossRef
5.
go back to reference Blair SN, Sallis RE, Hutber A, Archer E. Exercise therapy - the public health message. Scand J Med Sci Sports. 2012;22:24–8.CrossRef Blair SN, Sallis RE, Hutber A, Archer E. Exercise therapy - the public health message. Scand J Med Sci Sports. 2012;22:24–8.CrossRef
6.
go back to reference Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137–62.CrossRefPubMed Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16:137–62.CrossRefPubMed
7.
go back to reference Hinman RS, Nicolson PJ, Dobson FL, Bennell KL. Use of nondrug, nonoperative interventions by community-dwelling people with hip and knee osteoarthritis. Arthritis Care Res. 2015;67:305–9.CrossRef Hinman RS, Nicolson PJ, Dobson FL, Bennell KL. Use of nondrug, nonoperative interventions by community-dwelling people with hip and knee osteoarthritis. Arthritis Care Res. 2015;67:305–9.CrossRef
8.
go back to reference Smink AJ, van den Ende CH, Vliet Vlieland TP, Swierstra BA, Kortland JH, Bijlsma JW, et al. Beating osteoARThritis: Development of a stepped care strategy to optimize utilization and timing of non-surgical treatment modalities for patients with hip or knee osteoarthritis. Clin Rheumatol. 2011;30:1623–9.CrossRefPubMed Smink AJ, van den Ende CH, Vliet Vlieland TP, Swierstra BA, Kortland JH, Bijlsma JW, et al. Beating osteoARThritis: Development of a stepped care strategy to optimize utilization and timing of non-surgical treatment modalities for patients with hip or knee osteoarthritis. Clin Rheumatol. 2011;30:1623–9.CrossRefPubMed
9.
go back to reference Thorstensson CA, Roos EM, Petersson IF, Arvidsson B. How do middle-aged patients conceive exercise as a form of treatment for knee osteoarthritis? Disabil Rehabil. 2006;28:51–9.CrossRefPubMed Thorstensson CA, Roos EM, Petersson IF, Arvidsson B. How do middle-aged patients conceive exercise as a form of treatment for knee osteoarthritis? Disabil Rehabil. 2006;28:51–9.CrossRefPubMed
10.
go back to reference Westby MD. A health professional’s guide to exercise prescription for people with arthritis: a review of aerobic fitness activities. Arthritis Rheum. 2001;45:501–11.CrossRefPubMed Westby MD. A health professional’s guide to exercise prescription for people with arthritis: a review of aerobic fitness activities. Arthritis Rheum. 2001;45:501–11.CrossRefPubMed
11.
go back to reference Tilden HM, Reicherter EA, Reicherter F. Use of an aquatics program for older adults with osteoarthritis. From clinic to the community. Top Geriatr Rehabil. 2010;26:128–39.CrossRef Tilden HM, Reicherter EA, Reicherter F. Use of an aquatics program for older adults with osteoarthritis. From clinic to the community. Top Geriatr Rehabil. 2010;26:128–39.CrossRef
12.
go back to reference Becker BE. Aquatic therapy: scientific foundations and clinical rehabilitation applications. PM R. 2009;1:859–72.CrossRefPubMed Becker BE. Aquatic therapy: scientific foundations and clinical rehabilitation applications. PM R. 2009;1:859–72.CrossRefPubMed
13.
go back to reference Wilcock IM, Cronin JB, Hing WA. Physiological response to water immersion: a method for sport recovery? Sports Med. 2006;36:747–65.CrossRefPubMed Wilcock IM, Cronin JB, Hing WA. Physiological response to water immersion: a method for sport recovery? Sports Med. 2006;36:747–65.CrossRefPubMed
14.
go back to reference Waller B, Ogonowska-Slodownik A, Vitor M, Lambeck J, Daly D, Kujala UM, et al. Effect of therapeutic aquatic exercise on symptoms and function associated with lower limb osteoarthritis: systematic review with meta-analysis. Phys Ther. 2014;94:1383–95.CrossRefPubMed Waller B, Ogonowska-Slodownik A, Vitor M, Lambeck J, Daly D, Kujala UM, et al. Effect of therapeutic aquatic exercise on symptoms and function associated with lower limb osteoarthritis: systematic review with meta-analysis. Phys Ther. 2014;94:1383–95.CrossRefPubMed
15.
go back to reference Lu M, Su Y, Zhang Y, Zhang Z, Wang W, He Z, et al. Effectiveness of aquatic exercise for treatment of knee osteoarthritis: Systematic review and meta-analysis. Z Rheumatol. 2015;74:543–52.CrossRefPubMed Lu M, Su Y, Zhang Y, Zhang Z, Wang W, He Z, et al. Effectiveness of aquatic exercise for treatment of knee osteoarthritis: Systematic review and meta-analysis. Z Rheumatol. 2015;74:543–52.CrossRefPubMed
16.
go back to reference Barker AL, Talevski J, Morello RT, Brand CA, Rahmann AE, Urquhart DM. Effectiveness of aquatic exercise for musculoskeletal conditions: a meta-analysis. Arch Phys Med Rehabil. 2014;95:1776–86.CrossRefPubMed Barker AL, Talevski J, Morello RT, Brand CA, Rahmann AE, Urquhart DM. Effectiveness of aquatic exercise for musculoskeletal conditions: a meta-analysis. Arch Phys Med Rehabil. 2014;95:1776–86.CrossRefPubMed
17.
go back to reference Fisken A, Waters DL, Hing WA, Steele M, Keogh JW. Perception and responses to different forms of aqua-based exercise among older adults with osteoarthritis. Int J Aquat Res Educ. 2014;8:32–52.CrossRef Fisken A, Waters DL, Hing WA, Steele M, Keogh JW. Perception and responses to different forms of aqua-based exercise among older adults with osteoarthritis. Int J Aquat Res Educ. 2014;8:32–52.CrossRef
18.
go back to reference Schoedinger P. Watsu In Aquatic Rehabilitation. In: Becker BE, Cole AJ, editors. Comprehensive aquatic therapy. 3rd ed. Pullmann, WA 99164-5910: Washingtion State University Publishing; 2010. p. 137-51. Schoedinger P. Watsu In Aquatic Rehabilitation. In: Becker BE, Cole AJ, editors. Comprehensive aquatic therapy. 3rd ed. Pullmann, WA 99164-5910: Washingtion State University Publishing; 2010. p. 137-51.
19.
go back to reference Mangione KK, McCully K, Gloviak A, Lefebvre I, Hofmann M, Craik R. The effects of high-intensity and low-intensity cycle ergometry in older adults with knee osteoarthritis. J Gerontol A Biol Sci Med Sci. 1999;54(M):184–90.CrossRef Mangione KK, McCully K, Gloviak A, Lefebvre I, Hofmann M, Craik R. The effects of high-intensity and low-intensity cycle ergometry in older adults with knee osteoarthritis. J Gerontol A Biol Sci Med Sci. 1999;54(M):184–90.CrossRef
20.
go back to reference Salacinski AJ, Krohn K, Lewis SF, Holland ML, Ireland K, Marchetti G. The effects of group cycling on gait and pain-related disability in individuals with mild-to-moderate knee osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2012;42:985–95.CrossRefPubMed Salacinski AJ, Krohn K, Lewis SF, Holland ML, Ireland K, Marchetti G. The effects of group cycling on gait and pain-related disability in individuals with mild-to-moderate knee osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2012;42:985–95.CrossRefPubMed
23.
go back to reference Moser S. Entwicklung und Überprüfung eines Aqua-Cycling-Programms für Rheumapatienten. Universität Karlsruhe: Karlsruhe; 2009. Moser S. Entwicklung und Überprüfung eines Aqua-Cycling-Programms für Rheumapatienten. Universität Karlsruhe: Karlsruhe; 2009.
24.
go back to reference Rewald S, Mesters I, Emans PJ, Arts JJ, Lenssen AF, de Bie RA. Aquatic circuit training including aqua-cycling in patients with knee osteoarthritis: A feasibility study. J Rehabil Med. 2015;47:376–81.CrossRefPubMed Rewald S, Mesters I, Emans PJ, Arts JJ, Lenssen AF, de Bie RA. Aquatic circuit training including aqua-cycling in patients with knee osteoarthritis: A feasibility study. J Rehabil Med. 2015;47:376–81.CrossRefPubMed
25.
go back to reference Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMed Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMed
26.
27.
go back to reference Ackerman IN, Buchbinder R, Osborne RH. Factors limiting participation in arthritis self-management programmes: an exploration of barriers and patient preferences within a randomized controlled trial. Rheumatology. 2013;52:472–9.CrossRefPubMed Ackerman IN, Buchbinder R, Osborne RH. Factors limiting participation in arthritis self-management programmes: an exploration of barriers and patient preferences within a randomized controlled trial. Rheumatology. 2013;52:472–9.CrossRefPubMed
28.
go back to reference Cardinal BJ, Esters J, Cardinal MK. Evaluation of the revised physical activity readiness questionnaire in older adults. Med Sci Sports Exerc. 1996;28:468–72.CrossRefPubMed Cardinal BJ, Esters J, Cardinal MK. Evaluation of the revised physical activity readiness questionnaire in older adults. Med Sci Sports Exerc. 1996;28:468–72.CrossRefPubMed
29.
go back to reference Axford J, Butt A, Heron C, Hammond J, Morgan J, Alavi A, et al. Prevalence of anxiety and depression in osteoarthritis: use of the Hospital Anxiety and Depression Scale as a screening tool. Clin Rheumatol. 2010;29:1277–83.CrossRefPubMed Axford J, Butt A, Heron C, Hammond J, Morgan J, Alavi A, et al. Prevalence of anxiety and depression in osteoarthritis: use of the Hospital Anxiety and Depression Scale as a screening tool. Clin Rheumatol. 2010;29:1277–83.CrossRefPubMed
30.
go back to reference Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don’t patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001;55:132–8.PubMedCentralCrossRefPubMed Campbell R, Evans M, Tucker M, Quilty B, Dieppe P, Donovan JL. Why don’t patients do their exercises? Understanding non-compliance with physiotherapy in patients with osteoarthritis of the knee. J Epidemiol Community Health. 2001;55:132–8.PubMedCentralCrossRefPubMed
31.
32.
go back to reference Van der Leeden M, Staal JB, Beekman E, Hendriks H, Mesters I, de Rooij M, et al. Development of a framework to describe goals and content of exercise interventions in physical therapy: a mixed method approach including a systematic review. Phys Ther Rev. 2014;19:1–14.CrossRef Van der Leeden M, Staal JB, Beekman E, Hendriks H, Mesters I, de Rooij M, et al. Development of a framework to describe goals and content of exercise interventions in physical therapy: a mixed method approach including a systematic review. Phys Ther Rev. 2014;19:1–14.CrossRef
33.
go back to reference American Geriatrics Society Panel on Exercise and Osteoarthritis. Exercise prescription for older adults with osteoarthritis pain: consensus practice recommendations. A supplement to the AGS Clinical Practice Guidelines on the management of chronic pain in older adults. J Am Geriatr Soc. 2001;49:808-23. American Geriatrics Society Panel on Exercise and Osteoarthritis. Exercise prescription for older adults with osteoarthritis pain: consensus practice recommendations. A supplement to the AGS Clinical Practice Guidelines on the management of chronic pain in older adults. J Am Geriatr Soc. 2001;49:808-23.
34.
go back to reference Ericson MO, Bratt A, Nisell R, Németh R, Ekholm J. Load moments about the hip and knee joints during ergometer cycling. Scan J Rehabil Med. 1986;18:165–72. Ericson MO, Bratt A, Nisell R, Németh R, Ekholm J. Load moments about the hip and knee joints during ergometer cycling. Scan J Rehabil Med. 1986;18:165–72.
35.
go back to reference Silva LE, Valim V, Pessanha AP, Oliveira LM, Myamoto S, Jones A, et al. Hydrotherapy versus conventional land-based exercise for the management of patients with osteoarthritis of the knee: a randomized clinical trial. Phys Ther. 2008;88:12–21.CrossRefPubMed Silva LE, Valim V, Pessanha AP, Oliveira LM, Myamoto S, Jones A, et al. Hydrotherapy versus conventional land-based exercise for the management of patients with osteoarthritis of the knee: a randomized clinical trial. Phys Ther. 2008;88:12–21.CrossRefPubMed
36.
go back to reference Hinman RS, Heywood SE, Day AR. Aquatic physical therapy for hip and knee osteoarthritis: results of a single-blind randomized controlled trial. Phys Ther. 2007;87:32–43.CrossRefPubMed Hinman RS, Heywood SE, Day AR. Aquatic physical therapy for hip and knee osteoarthritis: results of a single-blind randomized controlled trial. Phys Ther. 2007;87:32–43.CrossRefPubMed
37.
go back to reference Foley A, Halbert J, Hewitt T, Crotty M. Does hydrotherapy improve strength and physical function in patients with osteoarthritis--a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme. Ann Rheum Dis. 2003;62:1162–7.PubMedCentralCrossRefPubMed Foley A, Halbert J, Hewitt T, Crotty M. Does hydrotherapy improve strength and physical function in patients with osteoarthritis--a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme. Ann Rheum Dis. 2003;62:1162–7.PubMedCentralCrossRefPubMed
38.
go back to reference Valtonen A, Poyhonen T, Sipila S, Heinonen A. Effects of aquatic resistance training on mobility limitation and lower-limb impairments after knee replacement. Arch Phys Med Rehabil. 2010;91:833–9.CrossRefPubMed Valtonen A, Poyhonen T, Sipila S, Heinonen A. Effects of aquatic resistance training on mobility limitation and lower-limb impairments after knee replacement. Arch Phys Med Rehabil. 2010;91:833–9.CrossRefPubMed
39.
go back to reference Dalichau S, Scheele K. Status of aquatic functional training in the therapy of chronic back pain. Phys Rehab Kur Med. 2003;13:35–41.CrossRef Dalichau S, Scheele K. Status of aquatic functional training in the therapy of chronic back pain. Phys Rehab Kur Med. 2003;13:35–41.CrossRef
40.
go back to reference Association AE. Aquatic fitness professional manual. 6th ed. Leeds: Human Kinetics; 2010. Association AE. Aquatic fitness professional manual. 6th ed. Leeds: Human Kinetics; 2010.
41.
go back to reference Johnston TE, Barr AE, Lee SC. Biomechanics of submaximal recumbent cycling in adolescents with and without cerebral palsy. Phys Ther. 2007;87:572–85.PubMedCentralCrossRefPubMed Johnston TE, Barr AE, Lee SC. Biomechanics of submaximal recumbent cycling in adolescents with and without cerebral palsy. Phys Ther. 2007;87:572–85.PubMedCentralCrossRefPubMed
42.
go back to reference Li L, Caldwell GE. Muscle coordination in cycling: effect of surface incline and posture. J Appl Physiol. 1998;85:927–34.PubMed Li L, Caldwell GE. Muscle coordination in cycling: effect of surface incline and posture. J Appl Physiol. 1998;85:927–34.PubMed
43.
go back to reference Caria MA, Tangianu F, Concu A, Crisafulli A, Mameli O. Quantification of spinning bike performance during a standard 50-minute class. J Sports Sci. 2007;25:421–9.CrossRefPubMed Caria MA, Tangianu F, Concu A, Crisafulli A, Mameli O. Quantification of spinning bike performance during a standard 50-minute class. J Sports Sci. 2007;25:421–9.CrossRefPubMed
44.
go back to reference Barbosa TM, Marinho DA, Reis VM, Silva AJ, Bragada J. Physiological assessment of head-out aquatic exercises in healthy subjects: a qualitative review. J Sports Sci Med. 2009;8:179–89.PubMedCentralPubMed Barbosa TM, Marinho DA, Reis VM, Silva AJ, Bragada J. Physiological assessment of head-out aquatic exercises in healthy subjects: a qualitative review. J Sports Sci Med. 2009;8:179–89.PubMedCentralPubMed
45.
go back to reference Barker KL, Dawes H, Hansford P, Shamley D. Perceived and measured levels of exertion of patients with chronic back pain exercising in a hydrotherapy pool. Arch Phys Med Rehabil. 2003;84:1319–23.CrossRefPubMed Barker KL, Dawes H, Hansford P, Shamley D. Perceived and measured levels of exertion of patients with chronic back pain exercising in a hydrotherapy pool. Arch Phys Med Rehabil. 2003;84:1319–23.CrossRefPubMed
47.
go back to reference Bennell KL, Hinman RS. A review of the clinical evidence for exercise in osteoarthritis of the hip and knee. J Sci Med Sport. 2011;14:4–9.CrossRefPubMed Bennell KL, Hinman RS. A review of the clinical evidence for exercise in osteoarthritis of the hip and knee. J Sci Med Sport. 2011;14:4–9.CrossRefPubMed
48.
go back to reference Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–40.PubMed Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15:1833–40.PubMed
49.
go back to reference de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of the Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008; doi.10.1186/1477-7525-6-16. de Groot IB, Favejee MM, Reijman M, Verhaar JA, Terwee CB. The Dutch version of the Knee Injury and Osteoarthritis Outcome Score: a validation study. Health Qual Life Outcomes. 2008; doi.10.​1186/​1477-7525-6-16.
50.
go back to reference Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003; doi.10.1186/1477-7525-1-64 Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003; doi.10.​1186/​1477-7525-1-64
51.
go back to reference Binkley JM, Stratford PW, Lott SA, Riddle DL. the lower extremity functional scale (LEFS): scale development, measurement properties, and clinical application. North American orthopaedic rehabilitation research network. Phys Ther. 1999;79:371–83.PubMed Binkley JM, Stratford PW, Lott SA, Riddle DL. the lower extremity functional scale (LEFS): scale development, measurement properties, and clinical application. North American orthopaedic rehabilitation research network. Phys Ther. 1999;79:371–83.PubMed
52.
go back to reference Hoogeboom TJ, de Bie RA, den Broeder AA, van den Ende CH. The Dutch Lower Extremity Functional Scale was highly reliable, valid and responsive in individuals with hip/knee osteoarthritis: a validation study. BMC Musculoskelet Disord. 2012; doi.10.1186/1471-2474-13-117. Hoogeboom TJ, de Bie RA, den Broeder AA, van den Ende CH. The Dutch Lower Extremity Functional Scale was highly reliable, valid and responsive in individuals with hip/knee osteoarthritis: a validation study. BMC Musculoskelet Disord. 2012; doi.10.​1186/​1471-2474-13-117.
53.
go back to reference Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997;24:799–802.PubMed Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol. 1997;24:799–802.PubMed
54.
go back to reference Perrot S, Rozenberg S, Moyse D, Legout V, Marty M. Comparison of daily, weekly or monthly pain assessments in hip and knee osteoarthritis. A 29-day prospective study. Joint Bone Spine. 2011;78:510–5.CrossRefPubMed Perrot S, Rozenberg S, Moyse D, Legout V, Marty M. Comparison of daily, weekly or monthly pain assessments in hip and knee osteoarthritis. A 29-day prospective study. Joint Bone Spine. 2011;78:510–5.CrossRefPubMed
55.
go back to reference Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994;56:217–26.CrossRefPubMed Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994;56:217–26.CrossRefPubMed
56.
go back to reference Gallasch CH, Alexandre NM. The measurement of musculoskeletal pain intensity: a comparison of four methods. Rev Gaucha Enferm. 2007;28:260–5.PubMed Gallasch CH, Alexandre NM. The measurement of musculoskeletal pain intensity: a comparison of four methods. Rev Gaucha Enferm. 2007;28:260–5.PubMed
57.
go back to reference Pham T, Van Der Heijde D, Lassere M, Altman RD, Anderson JJ, Bellamy N, et al. Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30:1648–54.PubMed Pham T, Van Der Heijde D, Lassere M, Altman RD, Anderson JJ, Bellamy N, et al. Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30:1648–54.PubMed
58.
go back to reference Pincus T, Bergman M, Sokka T, Roth J, Swearingen C, Yazici Y. Visual analog scales in formats other than a 10 centimeter horizontal line to assess pain and other clinical data. J Rheumatol. 2008;35:1550–8.PubMed Pincus T, Bergman M, Sokka T, Roth J, Swearingen C, Yazici Y. Visual analog scales in formats other than a 10 centimeter horizontal line to assess pain and other clinical data. J Rheumatol. 2008;35:1550–8.PubMed
59.
go back to reference Carpenter MR, Carpenter RL, Peel J, Zukley LM, Angelopoulou KM, Fischer I, et al. The reliability of isokinetic and isometric leg strength measures among individuals with symptoms of mild osteoarthritis. J Sports Med Phys Fitness. 2006;46:585–9.PubMed Carpenter MR, Carpenter RL, Peel J, Zukley LM, Angelopoulou KM, Fischer I, et al. The reliability of isokinetic and isometric leg strength measures among individuals with symptoms of mild osteoarthritis. J Sports Med Phys Fitness. 2006;46:585–9.PubMed
60.
go back to reference Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006;86:1489–96.CrossRefPubMed Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006;86:1489–96.CrossRefPubMed
61.
go back to reference Peter WF, Jansen MJ, Hurkmans EJ, Bloo H, Dekker J, Dilling RG, et al. Physiotherapy in hip and knee osteoarthritis: development of a practice guideline concerning initial assessment, treatment and evaluation. Acta Reumatol Port. 2011;36:268–81.PubMed Peter WF, Jansen MJ, Hurkmans EJ, Bloo H, Dekker J, Dilling RG, et al. Physiotherapy in hip and knee osteoarthritis: development of a practice guideline concerning initial assessment, treatment and evaluation. Acta Reumatol Port. 2011;36:268–81.PubMed
62.
go back to reference Noren AM, Bogren U, Bolin J, Stenstrom C. Balance assessment in patients with peripheral arthritis: applicability and reliability of some clinical assessments. Physiother Res Int. 2001;6:193–204.CrossRefPubMed Noren AM, Bogren U, Bolin J, Stenstrom C. Balance assessment in patients with peripheral arthritis: applicability and reliability of some clinical assessments. Physiother Res Int. 2001;6:193–204.CrossRefPubMed
63.
go back to reference Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005;6:3.PubMedCentralCrossRefPubMed Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005;6:3.PubMedCentralCrossRefPubMed
64.
go back to reference Wright AA, Cook CE, Baxter GD, Dockerty JD, Abbott JH. A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. J Orthop Sports Phys Ther. 2011;41:319–27.CrossRefPubMed Wright AA, Cook CE, Baxter GD, Dockerty JD, Abbott JH. A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. J Orthop Sports Phys Ther. 2011;41:319–27.CrossRefPubMed
65.
go back to reference Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–8.CrossRefPubMed Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39:142–8.CrossRefPubMed
66.
go back to reference Freter SH, Fruchter N. Relationship between timed ‘up and go’ and gait time in an elderly orthopaedic rehabilitation population. Clin Rehabil. 2000;14:96–101.CrossRefPubMed Freter SH, Fruchter N. Relationship between timed ‘up and go’ and gait time in an elderly orthopaedic rehabilitation population. Clin Rehabil. 2000;14:96–101.CrossRefPubMed
67.
go back to reference Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J. 1982;284:1607–8.CrossRef Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J. 1982;284:1607–8.CrossRef
68.
go back to reference Statement ATS. Guidelines for the Six-Minute Walk Test. Am J Respir Crit Care Med. 2002;166:111–7.CrossRef Statement ATS. Guidelines for the Six-Minute Walk Test. Am J Respir Crit Care Med. 2002;166:111–7.CrossRef
69.
go back to reference Pankoff BA, Overend TJ, Lucy SD, White KP. Reliability of the six-minute walk test in people with fibromyalgia. Arthritis Care Res. 2000;13:291–5.CrossRefPubMed Pankoff BA, Overend TJ, Lucy SD, White KP. Reliability of the six-minute walk test in people with fibromyalgia. Arthritis Care Res. 2000;13:291–5.CrossRefPubMed
70.
go back to reference Faggiano P, D’Aloia A, Gualeni A, Lavatelli A, Giordano A. Assessment of oxygen uptake during the 6-minute walking test in patients with heart failure: preliminary experience with a portable device. Am Heart J. 1997;134:203–6.CrossRefPubMed Faggiano P, D’Aloia A, Gualeni A, Lavatelli A, Giordano A. Assessment of oxygen uptake during the 6-minute walking test in patients with heart failure: preliminary experience with a portable device. Am Heart J. 1997;134:203–6.CrossRefPubMed
71.
go back to reference Wendel-Vos GC, Schuit AJ, Saris WH, Kromhout D. Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003;56:1163–9.CrossRefPubMed Wendel-Vos GC, Schuit AJ, Saris WH, Kromhout D. Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003;56:1163–9.CrossRefPubMed
72.
go back to reference de Hollander EL, Zwart L, de Vries SI, Wendel-Vos W. The SQUASH was a more valid tool than the OBiN for categorizing adults according to the Dutch physical activity and the combined guideline. J Clin Epidemiol. 2012;65:73–81.CrossRefPubMed de Hollander EL, Zwart L, de Vries SI, Wendel-Vos W. The SQUASH was a more valid tool than the OBiN for categorizing adults according to the Dutch physical activity and the combined guideline. J Clin Epidemiol. 2012;65:73–81.CrossRefPubMed
73.
go back to reference Wagenmakers R, van den Akker-Scheek I, Groothoff JW, Zijlstra W, Bulstra SK, Kootstra JW, et al. Reliability and validity of the short questionnaire to assess health-enhancing physical activity (SQUASH) in patients after total hip arthroplasty. BMC Musculoskelet Disord. 2008; doi.10.1186/1471-2474-9-141. Wagenmakers R, van den Akker-Scheek I, Groothoff JW, Zijlstra W, Bulstra SK, Kootstra JW, et al. Reliability and validity of the short questionnaire to assess health-enhancing physical activity (SQUASH) in patients after total hip arthroplasty. BMC Musculoskelet Disord. 2008; doi.10.​1186/​1471-2474-9-141.
74.
go back to reference Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.CrossRefPubMed Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83.CrossRefPubMed
75.
go back to reference Angst F, Aeschlimann A, Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis. 2001;60:834–40.PubMedCentralPubMed Angst F, Aeschlimann A, Steiner W, Stucki G. Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention. Ann Rheum Dis. 2001;60:834–40.PubMedCentralPubMed
76.
go back to reference Kosinski M, Keller SD, Ware Jr JE, Hatoum HT, Kong SX. The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: relative validity of scales in relation to clinical measures of arthritis severity. Med Care. 1999;37 Suppl 5:23–39. Kosinski M, Keller SD, Ware Jr JE, Hatoum HT, Kong SX. The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis: relative validity of scales in relation to clinical measures of arthritis severity. Med Care. 1999;37 Suppl 5:23–39.
77.
go back to reference Veenhof C, Bijlsma JW, van den Ende CH, van Dijk GM, Pisters MF, Dekker J. Psychometric evaluation of osteoarthritis questionnaires: a systematic review of the literature. Arthritis Rheum. 2006;55:480–92.CrossRefPubMed Veenhof C, Bijlsma JW, van den Ende CH, van Dijk GM, Pisters MF, Dekker J. Psychometric evaluation of osteoarthritis questionnaires: a systematic review of the literature. Arthritis Rheum. 2006;55:480–92.CrossRefPubMed
78.
go back to reference Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, et al. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998;51:1055–68.CrossRefPubMed Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, et al. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998;51:1055–68.CrossRefPubMed
80.
go back to reference Kori S, Miller R, Todd C. Kinesiophobia: a new view of chronic pain behavior. Pain Manag. 1990;3:35-43. Kori S, Miller R, Todd C. Kinesiophobia: a new view of chronic pain behavior. Pain Manag. 1990;3:35-43.
81.
go back to reference Swinkels-Meewisse EJ, Swinkels RA, Verbeek AL, Vlaeyen JW, Oostendorp RA. Psychometric properties of the Tampa Scale for kinesiophobia and the fear-avoidance beliefs questionnaire in acute low back pain. Man Ther. 2003;8:29–36.CrossRefPubMed Swinkels-Meewisse EJ, Swinkels RA, Verbeek AL, Vlaeyen JW, Oostendorp RA. Psychometric properties of the Tampa Scale for kinesiophobia and the fear-avoidance beliefs questionnaire in acute low back pain. Man Ther. 2003;8:29–36.CrossRefPubMed
82.
go back to reference Mielenz TJ, Edwards MC, Callahan LF. Item Response Theory Analysis of Two Questionnaire Measures of Arthritis-Related Self-Efficacy Beliefs from Community-Based US Samples. Arthritis. 2010; doi.10.1155/2010/416796. Mielenz TJ, Edwards MC, Callahan LF. Item Response Theory Analysis of Two Questionnaire Measures of Arthritis-Related Self-Efficacy Beliefs from Community-Based US Samples. Arthritis. 2010; doi.10.​1155/​2010/​416796.
83.
go back to reference Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32:37–44.CrossRefPubMed Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32:37–44.CrossRefPubMed
84.
go back to reference Taal E, Riemsma RP, Brus HL, Seydel ER, Rasker JJ, Wiegman O. Group education for patients with rheumatoid arthritis. Patient Educ Couns. 1993;20:177–87.CrossRefPubMed Taal E, Riemsma RP, Brus HL, Seydel ER, Rasker JJ, Wiegman O. Group education for patients with rheumatoid arthritis. Patient Educ Couns. 1993;20:177–87.CrossRefPubMed
85.
go back to reference Brady TJ. Measures of self-efficacy: Arthritis Self-Efficacy Scale (ASES), Arthritis Self-Efficacy Scale-8 Item (ASES-8), Children’s Arthritis Self-Efficacy Scale (CASE), Chronic Disease Self-Efficacy Scale (CDSES), Parent’s Arthritis Self-Efficacy Scale (PASE), and Rheumatoid Arthritis Self-Efficacy Scale (RASE). Arthritis Care Res (Hoboken). 2011; doi.10.1002/acr.20567. Brady TJ. Measures of self-efficacy: Arthritis Self-Efficacy Scale (ASES), Arthritis Self-Efficacy Scale-8 Item (ASES-8), Children’s Arthritis Self-Efficacy Scale (CASE), Chronic Disease Self-Efficacy Scale (CDSES), Parent’s Arthritis Self-Efficacy Scale (PASE), and Rheumatoid Arthritis Self-Efficacy Scale (RASE). Arthritis Care Res (Hoboken). 2011; doi.10.​1002/​acr.​20567.
86.
go back to reference Dekker J, van Dijk GM, Veenhof C. Risk factors for functional decline in osteoarthritis of the hip or knee. Curr Opin Rheumatol. 2009;21:520–4.CrossRefPubMed Dekker J, van Dijk GM, Veenhof C. Risk factors for functional decline in osteoarthritis of the hip or knee. Curr Opin Rheumatol. 2009;21:520–4.CrossRefPubMed
87.
go back to reference Allen KD, Golightly YM, Olsen MK. Pilot study of pain and coping among patients with osteoarthritis: a daily diary analysis. J Clin Rheumatol. 2006;12:118–23.CrossRefPubMed Allen KD, Golightly YM, Olsen MK. Pilot study of pain and coping among patients with osteoarthritis: a daily diary analysis. J Clin Rheumatol. 2006;12:118–23.CrossRefPubMed
89.
go back to reference Maiers M, Evans R, Hartvigsen J, Schulz C, Bronfort G. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial. Man Ther. 2015;20:335–41.CrossRefPubMed Maiers M, Evans R, Hartvigsen J, Schulz C, Bronfort G. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial. Man Ther. 2015;20:335–41.CrossRefPubMed
90.
go back to reference International Conference on Harmonisation of technicalrequirements for registration of pharmaceuticals for human use. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001;47:45-50. International Conference on Harmonisation of technicalrequirements for registration of pharmaceuticals for human use. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001;47:45-50.
91.
go back to reference King DW, Lashley R. A quantifiable alternative to double data entry. Control Clin Trials. 2000;21:94–102.CrossRefPubMed King DW, Lashley R. A quantifiable alternative to double data entry. Control Clin Trials. 2000;21:94–102.CrossRefPubMed
92.
go back to reference Dodge HF. Sampling plans for continuous production. Ind Qual Control. 1947;14:5–9. Dodge HF. Sampling plans for continuous production. Ind Qual Control. 1947;14:5–9.
93.
go back to reference Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005;64:29–33.PubMedCentralCrossRefPubMed Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005;64:29–33.PubMedCentralCrossRefPubMed
94.
go back to reference Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001;45:384–91.CrossRefPubMed Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001;45:384–91.CrossRefPubMed
95.
go back to reference Ettinger Jr WH, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, et al. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The fitness arthritis and seniors trial (FAST). JAMA. 1997;277:25–31.CrossRefPubMed Ettinger Jr WH, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, et al. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The fitness arthritis and seniors trial (FAST). JAMA. 1997;277:25–31.CrossRefPubMed
96.
go back to reference Bressel E, Wing JE, Miller AI, Dolny DG. High-intensity interval training on an aquatic treadmill in adults with osteoarthritis: effect on pain, balance, function, and mobility. J Strength Cond Res. 2014;28:2088–96.CrossRefPubMed Bressel E, Wing JE, Miller AI, Dolny DG. High-intensity interval training on an aquatic treadmill in adults with osteoarthritis: effect on pain, balance, function, and mobility. J Strength Cond Res. 2014;28:2088–96.CrossRefPubMed
Metadata
Title
Effect of aqua-cycling on pain and physical functioning compared with usual care in patients with knee osteoarthritis: study protocol of a randomised controlled trial
Authors
Stefanie Rewald
Ilse Mesters
A. F. Lenssen
Pieter J. Emans
Wiel Wijnen
Rob A. de Bie
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2016
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-016-0939-5

Other articles of this Issue 1/2016

BMC Musculoskeletal Disorders 1/2016 Go to the issue