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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2012

Open Access 01-12-2012 | Study protocol

Land- and water-based exercise intervention in women with fibromyalgia: the al-andalus physical activity randomised controlled trial

Authors: Ana Carbonell-Baeza, Jonatan R Ruiz, Virginia A Aparicio, Francisco B Ortega, Diego Munguía-Izquierdo, Inmaculada C Álvarez-Gallardo, Víctor Segura-Jiménez, Daniel Camiletti-Moirón, Alejandro Romero, Fernando Estévez-López, Blanca Samos, Antonio J Casimiro, Ángela Sierra, Pedro A Latorre, Manuel Pulido-Martos, Pedro Femia, Isaac J Pérez-López, Palma Chillón, María J Girela-Rejón, Pablo Tercedor, Alejandro Lucía, Manuel Delgado-Fernández

Published in: BMC Musculoskeletal Disorders | Issue 1/2012

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Abstract

Background

The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia.

Methods/Design

One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will be randomly assigned to a usual care (control) group (n = 60), a water-based exercise intervention group (n = 60) or a land-based exercise intervention group (n = 60). Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each) per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention) on the studied variables.

Discussion

Our study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia.

Trial registration

ClinicalTrials.gov ID: NCT01490281
Appendix
Available only for authorised users
Literature
1.
Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP: Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010, 39 (6): 448-453. 10.1016/j.semarthrit.2008.12.003.CrossRefPubMed
2.
Mas AJ, Carmona L, Valverde M, Ribas B: Prevalence and impact of fibromyalgia on function and quality of life in individuals from the general population: results from a nationwide study in Spain. Clin Exp Rheumatol. 2008, 26 (4): 519-526.PubMed
3.
Sarzi-Puttini P, Buskila D, Carrabba M, Doria A, Atzeni F: Treatment strategy in fibromyalgia syndrome: where are we now?. Semin Arthritis Rheum. 2008, 37 (6): 353-365. 10.1016/j.semarthrit.2007.08.008.CrossRefPubMed
4.
Mork PJ, Vasseljen O, Nilsen TI: Association between physical exercise, body mass index, and risk of fibromyalgia: longitudinal data from the Norwegian Nord-Trondelag Health Study. Arthritis Care Res (Hoboken). 2010, 62 (5): 611-617. 10.1002/acr.20118.CrossRef
5.
Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L: An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord. 2007, 8: 27-10.1186/1471-2474-8-27.CrossRefPubMedPubMedCentral
6.
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P: The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the multicenter criteria committee. Arthritis Rheum. 1990, 33 (2): 160-172. 10.1002/art.1780330203.CrossRefPubMed
7.
Wilson HD, Robinson JP, Turk DC: Toward the identification of symptom patterns in people with fibromyalgia. Arthritis Rheum. 2009, 61 (4): 527-534. 10.1002/art.24163.CrossRefPubMedPubMedCentral
8.
Wolfe F, Michaud K, Li T, Katz RS: Chronic conditions and health problems in rheumatic diseases: comparisons with rheumatoid arthritis, noninflammatory rheumatic disorders, systemic lupus erythematosus, and fibromyalgia. J Rheumatol. 2010, 37 (2): 305-315. 10.3899/jrheum.090781.CrossRefPubMed
9.
Lachaine J, Beauchemin C, Landry PA: Clinical and economic characteristics of patients with fibromyalgia syndrome. Clin J Pain. 2010, 26 (4): 284-290. 10.1097/AJP.0b013e3181cf599f.CrossRefPubMed
10.
Gormsen L, Rosenberg R, Bach FW, Jensen TS: Depression, anxiety, health-related quality of life and pain in patients with chronic fibromyalgia and neuropathic pain. Eur J Pain. 2010, 14 (2): 127-e121-128CrossRefPubMed
11.
Verbunt JA, Pernot DH, Smeets RJ: Disability and quality of life in patients with fibromyalgia. Health Qual Life Outcomes. 2008, 6: 8-10.1186/1477-7525-6-8.CrossRefPubMedPubMedCentral
12.
Henriksson C, Gundmark I, Bengtsson A, Ek AC: Living with fibromyalgia. Consequences for everyday life. Clin J Pain. 1992, 8 (2): 138-144. 10.1097/00002508-199206000-00012.CrossRefPubMed
13.
Valim V, Oliveira LM, Suda AL, Silva LE, Faro M, Neto TL, Feldman D, Natour J: Peak oxygen uptake and ventilatory anaerobic threshold in fibromyalgia. J Rheumatol. 2002, 29 (2): 353-357.PubMed
14.
Valkeinen H, Hakkinen A, Alen M, Hannonen P, Kukkonen-Harjula K, Hakkinen K: Physical fitness in postmenopausal women with fibromyalgia. Int J Sports Med. 2008, 29 (5): 408-413. 10.1055/s-2007-965818.CrossRefPubMed
15.
Jones KD, Horak FB, Winters-Stone K, Irvine JM, Bennett RM: Fibromyalgia is associated with impaired balance and falls. J Clin Rheumatol. 2009, 15 (1): 16-21. 10.1097/RHU.0b013e318190f991.CrossRefPubMedPubMedCentral
16.
Panton LB, Kingsley JD, Toole T, Cress ME, Abboud G, Sirithienthad P, Mathis R, McMillan V: A comparison of physical functional performance and strength in women with fibromyalgia, age- and weight-matched controls, and older women who are healthy. Phys Ther. 2006, 86 (11): 1479-1488. 10.2522/ptj.20050320.CrossRefPubMed
17.
Heredia Jimenez JM, Aparicio Garcia-Molina VA, Porres Foulquie JM, Delgado Fernandez M, Soto Hermoso VM: Spatial-temporal parameters of gait in women with fibromyalgia. Clin Rheumatol. 2009, 28 (5): 595-598. 10.1007/s10067-009-1101-7.CrossRefPubMed
18.
Carbonell-Baeza A, Aparicio VA, Sjostrom M, Ruiz JR, Delgado-Fernandez M: Pain and functional capacity in female fibromyalgia patients. Pain Med. 2011, 12 (11): 1667-1675. 10.1111/j.1526-4637.2011.01239.x.CrossRefPubMed
19.
Jones J, Rutledge DN, Jones KD, Matallana L, Rooks DS: Self-assessed physical function levels of women with fibromyalgia: a national survey. Womens Health Issues. 2008, 18 (5): 406-412. 10.1016/j.whi.2008.04.005.CrossRefPubMed
20.
Thomas EN, Blotman F: Aerobic exercise in fibromyalgia: a practical review. Rheumatol Int. 2010, 30 (9): 1143-1150. 10.1007/s00296-010-1369-6.CrossRefPubMed
21.
Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL: Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011, 15 (5): 358-367. 10.1007/s11916-011-0214-2.CrossRefPubMedPubMedCentral
22.
Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL: Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007, 4: CD003786-PubMed
23.
Kelley GA, Kelley KS, Hootman JM, Jones DL: Exercise and global well-being in community-dwelling adults with fibromyalgia: a systematic review with meta-analysis. BMC Publ Health. 2010, 10 (1): 198-10.1186/1471-2458-10-198.CrossRef
24.
Brosseau L, Wells GA, Tugwell P, Egan M, Wilson KG, Dubouloz CJ, Casimiro L, Robinson VA, McGowan J, Busch A: Ottawa Panel evidence-based clinical practice guidelines for aerobic fitness exercises in the management of fibromyalgia: part 1. Phys Ther. 2008, 88 (7): 857-871. 10.2522/ptj.20070200.CrossRefPubMed
25.
Brosseau L, Wells GA, Tugwell P, Egan M, Wilson KG, Dubouloz CJ, Casimiro L, Robinson VA, McGowan J, Busch A: Ottawa Panel evidence-based clinical practice guidelines for strengthening exercises in the management of fibromyalgia: part 2. Phys Ther. 2008, 88 (7): 873-886. 10.2522/ptj.20070115.CrossRefPubMed
26.
Hauser W, Klose P, Langhorst J, Moradi B, Steinbach M, Schiltenwolf M, Busch A: Efficacy of different types of aerobic exercise in fibromyalgia syndrome: a systematic review and meta-analysis of randomised controlled trials. Arthritis Res Ther. 2010, 12 (3): R79-10.1186/ar3002.CrossRefPubMedPubMedCentral
27.
Cazzola M, Atzeni F, Salaffi F, Stisi S, Cassisi G, Sarzi-Puttini P: Which kind of exercise is best in fibromyalgia therapeutic programmes? A practical review. Clin Exp Rheumatol. 2010, 28 (6 Suppl 63): S117-S124.PubMed
28.
Jentoft ES, Kvalvik AG, Mengshoel AM: Effects of pool-based and land-based aerobic exercise on women with fibromyalgia/chronic widespread muscle pain. Arthritis Rheum. 2001, 45 (1): 42-47. 10.1002/1529-0131(200102)45:1<42::AID-ANR82>3.0.CO;2-A.CrossRefPubMed
29.
Cardinal BJ, Esters J, Cardinal MK: Evaluation of the revised physical activity readiness questionnaire in older adults. Med Sci Sports Exerc. 1996, 28 (4): 468-472. 10.1097/00005768-199604000-00011.CrossRefPubMed
30.
Rivera J, Gonzalez T: The Fibromyalgia impact questionnaire: a validated Spanish version to assess the health status in women with fibromyalgia. Clin Exp Rheumatol. 2004, 22 (5): 554-560.PubMed
31.
Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB: Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009, 36 (6): 1304-1311. 10.3899/jrheum.081090.CrossRefPubMed
32.
Holm S: A simple sequentially rejective multiple test procedure. Scand J Statist. 1979, 6: 65-70.
33.
Hollis S, Campbell F: What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999, 319 (7211): 670-674. 10.1136/bmj.319.7211.670.CrossRefPubMedPubMedCentral
34.
Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP: American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011, 43 (7): 1334-1359. 10.1249/MSS.0b013e318213fefb.CrossRefPubMed
35.
36.
Persinger R, Foster C, Gibson M, Fater DC, Porcari JP: Consistency of the talk test for exercise prescription. Med Sci Sports Exerc. 2004, 36 (9): 1632-1636.PubMed
37.
Sullivan MJL, Bishop S, Pivik J: The pain catastrophizing scale: development and validation. Psychol Assess. 1995, 7: 524-532.CrossRef
38.
Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S: Validation of the Spanish version of the pain catastrophizing scale in fibromyalgia. Med Clin (Barc). 2008, 131 (13): 487-492. 10.1157/13127277.CrossRef
39.
Anderson KO, Dowds BN, Pelletz RE, Edwards WT, Peeters-Asdourian C: Development and initial validation of a scale to measure self-efficacy beliefs in patients with chronic pain. Pain. 1995, 63 (1): 77-84. 10.1016/0304-3959(95)00021-J.CrossRefPubMed
40.
Martín-Aragón M, Pastor MA, Rodríguez-Marín J, March MJ, Lledó A, López-Roig S, Terol MC: Percepción de autoeficacia en dolor crónico: Adaptación y validación de la Chronic Pain Self-Efficacy Scale. Revista de Psicología de la Salud. 1999, 11: 53-75.
41.
Rikli RE, Jones J: Development and validation of a functional fitness test for community residing older adults. J Aging Phys Act. 1999, 7: 129-161.
42.
Ruiz-Ruiz J, Mesa JL, Gutierrez A, Castillo MJ: Hand size influences optimal grip span in women but not in men. J Hand Surg Am. 2002, 27 (5): 897-901. 10.1053/jhsu.2002.34315.CrossRefPubMed
43.
King S, Wessel J, Bhambhani Y, Maikala R, Sholter D, Maksymowych W: Validity and reliability of the 6 minute walk in persons with fibromyalgia. J Rheumatol. 1999, 26 (10): 2233-2237.PubMed
44.
Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA: The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011, 40 (3): 701-711. 10.1093/ije/dyr039.CrossRefPubMed
45.
Mannerkorpi K, Hernelid C: Leisure time physical activity instrument and physical activity at home and work instrument. Development, face validity, construct validity and test-retest reliability for subjects with fibromyalgia. Disabil Rehabil. 2005, 27 (12): 695-701. 10.1080/09638280400009063.CrossRefPubMed
46.
Munguia-Izquierdo D, Legaz-Arrese A, Mannerkorpi K: Transcultural adaptation and psychometric properties of a Spanish-language version of physical activity instruments for patients with fibromyalgia. Arch Phys Med Rehabil. 2011, 92 (2): 284-294. 10.1016/j.apmr.2010.10.019.CrossRefPubMed
47.
Rosenberg DE, Norman GJ, Wagner N, Patrick K, Calfas KJ, Sallis JF: Reliability and validity of the Sedentary Behavior Questionnaire (SBQ) for adults. J Phys Act Health. 2010, 7 (6): 697-705.PubMed
48.
Spittaels H, Foster C, Oppert JM, Rutter H, Oja P, Sjostrom M, De Bourdeaudhuij I: Assessment of environmental correlates of physical activity: development of a European questionnaire. Int J Behav Nutr Phys Act. 2009, 6: 39-10.1186/1479-5868-6-39.CrossRefPubMedPubMedCentral
49.
Spittaels H, Verloigne M, Gidlow C, Gloanec J, Titze S, Foster C, Oppert JM, Rutter H, Oja P, Sjostrom M: Measuring physical activity-related environmental factors: reliability and predictive validity of the European environmental questionnaire ALPHA. Int J Behav Nutr Phys Act. 2010, 7 (1): 48-10.1186/1479-5868-7-48.CrossRefPubMedPubMedCentral
50.
Smets EM, Garssen B, Bonke B, De Haes JC: The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995, 39 (3): 315-325. 10.1016/0022-3999(94)00125-O.CrossRefPubMed
51.
Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ: The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989, 28 (2): 193-213. 10.1016/0165-1781(89)90047-4.CrossRefPubMed
52.
Bigatti SM, Hernandez AM, Cronan TA, Rand KL: Sleep disturbances in fibromyalgia syndrome: relationship to pain and depression. Arthritis Rheum. 2008, 59 (7): 961-967. 10.1002/art.23828.CrossRefPubMedPubMedCentral
53.
Munguia-Izquierdo D, Legaz-Arrese A: Assessment of the effects of aquatic therapy on global symptomatology in patients with fibromyalgia syndrome: a randomized controlled trial. Arch Phys Med Rehabil. 2008, 89 (12): 2250-2257. 10.1016/j.apmr.2008.03.026.CrossRefPubMed
54.
Alonso J, Prieto L, Anto JM: The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results. Med Clin (Barc). 1995, 104 (20): 771-776.
55.
Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4: 561-571. 10.1001/archpsyc.1961.01710120031004.CrossRefPubMed
56.
Beck AT, Steer RA, Brown GK: BDI-II. 2006, Inventario de depresión de beck. Buenos Aires: Editorial Paidos
57.
STAI: Manual del Cuestionario de Ansiedad Estado-Rasgo. Edited by: Spielberger CD, Gorsuch RL, Lushene RE. 2002, Madrid: TEA Ediciones
58.
Fernandez-Berrocal P, Extremera N, Ramos N: Validity and reliability of the Spanish modified version of the trait meta-mood scale. Psychol Rep. 2004, 94 (3 Pt 1): 751-755.CrossRefPubMed
59.
Watson D, Clark LA, Tellegen A: Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988, 54 (6): 1063-1070.CrossRefPubMed
60.
Sandín B, Chorot P, Lostao L, Joiner TE, Santed MA, Valiente RM: Escalas PANAS de afecto positivo y negativo: validación factorial y convergencia transcultural. Psicothema. 1999, 14: 333-339.
61.
Diener E, Emmons RA, Larsen RJ, Griffin S: The satisfaction with life scale. J Pers Assess. 1985, 49 (1): 71-75. 10.1207/s15327752jpa4901_13.CrossRefPubMed
62.
Atienza FL, Pons D, Balaguer I, García-Merita M: Propiedades Psicométricas de la Escala de Satisfacción con la Vida en Adolescentes. Psicothema. 2000, 12 (32): 314-319.
63.
Scheier MF, Carver CS, Bridges MW: Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the life orientation test. J Pers Soc Psychol. 1994, 67 (6): 1063-1078.CrossRefPubMed
64.
Otero JM, Luengo A, Romero E, Gómez JA, Castro C: Psicología de la Personalidad. 1998, Manual de prácticas. Barcelona: Ariel Practicum
65.
Folstein MF, Folstein SE, McHugh PR: Mini-mental state. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975, 12 (3): 189-198. 10.1016/0022-3956(75)90026-6.CrossRefPubMed
66.
Gronwall DM: Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977, 44 (2): 367-373. 10.2466/pms.1977.44.2.367.CrossRefPubMed
67.
Rey A: L'examen clinique en psychologie. 1958, Paris: Presse Universitaire de France
68.
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N: Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005, 113 (1-2): 9-19. 10.1016/j.pain.2004.09.012.CrossRefPubMed
Metadata
Title
Land- and water-based exercise intervention in women with fibromyalgia: the al-andalus physical activity randomised controlled trial
Authors
Ana Carbonell-Baeza
Jonatan R Ruiz
Virginia A Aparicio
Francisco B Ortega
Diego Munguía-Izquierdo
Inmaculada C Álvarez-Gallardo
Víctor Segura-Jiménez
Daniel Camiletti-Moirón
Alejandro Romero
Fernando Estévez-López
Blanca Samos
Antonio J Casimiro
Ángela Sierra
Pedro A Latorre
Manuel Pulido-Martos
Pedro Femia
Isaac J Pérez-López
Palma Chillón
María J Girela-Rejón
Pablo Tercedor
Alejandro Lucía
Manuel Delgado-Fernández
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2012
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-13-18

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