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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2018

Open Access 01-12-2018 | Study protocol

Facilitating physical activity and reducing symptoms in patients with knee osteoarthritis: study protocol of a randomized controlled trial to test a theory-based PrevOP-psychological adherence program (PrevOP-PAP)

Authors: Nina Knoll, Diana Hilda Hohl, Susannah Motter, Jan Keller, Daniela Lange, Dieter Felsenberg, Peter Martus, Wolfgang Ertel, Ralf Schwarzer

Published in: BMC Musculoskeletal Disorders | Issue 1/2018

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Abstract

Background

The present randomized controlled trial, which is crossed with the “PREVenting the impairment of primary Osteoarthritis by high impact long-term Physical exercise regimen” Main Medical Trial (PrevOP-MMT), aims to evaluate a psychological adherence program (PrevOP-PAP), and is designed to support persons with knee osteoarthritis (OAK) in the uptake and maintenance of regular physical activity to reduce OAK symptoms. The PrevOP-PAP is based on the Health Action Process Approach (HAPA), a social-cognitive theory predicting health behavior change in individuals, extended here by social network characteristics and social exchange processes. It is expected that participants with OAK receiving the PrevOP-PAP will maintain higher levels of regular physical activity throughout a 24-month period and consequently report lower levels of OAK symptoms than participants of an active control condition.

Methods

A total of N = 240 participants with medically verified moderate OAK will be randomly assigned to an intervention condition (PrevOP-PAP-I; 50%) or an active control condition (PrevOP-PAP-CTRL). The PrevOP-PAP-I includes a motivational intervention, repeated self-regulation interventions, and a network creation intervention delivered over 12 months. Modes of intervention delivery include a paper-pencil motivation leaflet with a quiz, a computer-assisted face-to-face intervention, four computer assisted phone-based interventions, and activity calendars. The PrevOP-PAP-CTRL includes the motivational intervention only. Primary outcome will be OAK symptoms. Secondary outcomes include objectively and subjectively measured physical activity and indicators of quality of life. Other outcomes are HAPA-derived self-regulatory indicators as well as proposed social network and social exchange mechanisms of health behavior change. Assessments take place at baseline, 6 months, 12 months, 18 months, and 24 months following baseline.

Discussion

Based on the extended HAPA, this study seeks to reveal the self-regulatory and social mechanisms of the uptake and maintenance of physical activity and their relation to disease symptoms in persons with OAK. The design and evaluation of this program are intended to become a yardstick for future development and implementation of digitalized psychological adherence programs in this population.

Trial registration

German Clinical Trials Register; also available at http://​apps.​who.​int/​trialsearch/​; registration number: DRKS00009677; date of registration: 26 January 2016.
Literature
1.
Bartholdy C, Juhl C, Christensen R, Lund H, Zhang W, Henriksen M. The role of muscle strengthening in exercise therapy for knee osteoarthritis: a systematic review and meta-regression analysis of randomized trials. Semin Arthritis Rheum. 2017;47:9–21.CrossRefPubMed
2.
Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015;49:1554–7.CrossRefPubMed
3.
4.
Gay C, Chabaud A, Guilley E, Coudeyre E. Educating patients about the benefits of physical activity and exercise for their hip and knee osteoarthritis. Systematic literature review. Ann Phys Rehabil Med. 2016;59:174–83.CrossRefPubMed
5.
Rhodes RE, de Bruijn G-J. How big is the physical activity intention-behaviour gap? A meta-analysis using the action control framework. Br J Health Psychol. 2013;18:296–309.CrossRefPubMed
6.
Brown GA. AAOS clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013;21:577–9.PubMed
7.
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthr Cartil. 2014;22:363–88.CrossRefPubMed
8.
9.
Barz M, Lange D, Parschau L, Lonsdale C, Knoll N, Schwarzer R. Self-efficacy, planning, and preparatory behaviours as joint predictors of physical activity: a conditional process analysis. Psychol Health. 2016;31:65–78.CrossRefPubMed
10.
Fleig L, Pomp S, Schwarzer R, Lippke S. Promoting exercise maintenance: how interventions with booster sessions improve long-term rehabilitation outcomes. Rehabil Psychol. 2013;58:323–33.CrossRefPubMed
11.
Focht BC, Garver MJ, Lucas AR, Devor ST, Emery CF, Hackshaw KV, Fairman CM, Bowman J, Rejeski WJ. A group-mediated physical activity intervention in older knee osteoarthritis patients: effects on social cognitive outcomes. J Behav Med. 2017;40:530–7.CrossRefPubMedPubMedCentral
12.
Keller J, Fleig L, Hohl DH, Wiedemann AU, Burkert S, Luszczynska A, Knoll N. Which characteristics of planning matter? Individual and dyadic physical activity plans and their effects on plan enactment. Soc Sci Med. 2017;189:53–62.CrossRefPubMed
13.
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46:81–95.CrossRefPubMed
14.
Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the health action process approach (HAPA). Rehabil Psychol. 2011;56:161–70.CrossRefPubMed
15.
Taylor SS, Oddone EZ, Coffman CJ, Jeffreys AS, Bosworth HB, Allen KD. Cognitive mediators of change in physical functioning in response to a multifaceted intervention for managing osteoarthritis. Int J Behav Med. 2018;25:162–70.CrossRefPubMed
16.
Schwarzer R. Modeling health behavior change. How to predict and modify the adoption and maintenance of health behaviors. Appl Psychol Int Rev. 2008;57:1–29.
17.
Bandura A. Self-efficacy: the exercise of control. New York: Freeman; 1997.
18.
Carver CS, Scheier MF. Control processes and self-organization as complementary principles underlying behavior. Personal Soc Psychol Rev. 2002;6:304–15.CrossRef
19.
Gollwitzer PM. Implementation intentions. Strong effects of simple plans. Am Psychol. 1999;54:493–503.CrossRef
20.
21.
Rosenstock IM. Historical origins of the health belief model. Health Educ Monogr. 1974;2:328–35.CrossRef
22.
Sniehotta FF, Scholz U, Schwarzer R. Bridging the intention-behaviour gap: planning, self-efficacy, and action control in the adoption and maintenance of physical exercise. Psychol Health. 2005;20:143–60.CrossRef
23.
Berli C, Stadler G, Shrout PE, Bolger N, Scholz U. Mediators of physical activity adherence: results from an action control intervention in couples. Ann Behav Med. 2018;52:65–76.PubMed
24.
Evers A, Klusmann V, Ziegelmann JP, Schwarzer R, Heuser I. Long-term adherence to a physical activity intervention: the role of telephone-assisted vs. self-administered coping plans and strategy use. Psychol Health. 2012;27:784–97.CrossRefPubMed
25.
Hagger MS, Luszczynska A. Implementation intention and action planning interventions in health contexts: state of the research and proposals for the way forward. Appl Psychol Health Well Being. 2014;6:1–47.CrossRefPubMed
26.
Kwasnicka D, Presseau J, White M, Sniehotta FF. Does planning how to cope with anticipated barriers facilitate health-related behaviour change? A systematic review. Health Psychol Rev. 2013;7:129–45.CrossRef
27.
Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: a longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006;11:23–37.CrossRefPubMed
28.
Hemphill RC, Martire LM, Polenick CA, Stephens MAP. Spouse confidence and physical function among adults with osteoarthritis: the mediating role of spouse responses to pain. Health Psychol. 2016;35:1059–68.CrossRefPubMedPubMedCentral
29.
Jackson SE, Steptoe A, Wardle J. The influence of partner’s behavior on health behavior change: the English longitudinal study of ageing. JAMA Intern Med. 2015;175:385–92.CrossRefPubMed
30.
Rackow P, Scholz U, Hornung R. Effects of a new sports companion on received social support and physical exercise: an intervention study. Appl Psychol Health Well Being. 2014;6:300–17.CrossRefPubMed
31.
Burkert S, Scholz U, Gralla O, Roigas J, Knoll N. Dyadic planning of health-behavior change after prostatectomy: a randomized-controlled planning intervention. Soc Sci Med. 2011;73:783–92.CrossRefPubMed
32.
Knoll N, Hohl DH, Keller J, Schuez N, Luszczynska A, Burkert S. Effects of dyadic planning on physical activity in couples: a randomized controlled trial. Health Psychol. 2017;36:8–20.CrossRefPubMed
33.
Berli C, Bolger N, Shrout PE, Stadler G, Scholz U. Interpersonal processes of couples' daily support for goal pursuit: the example of physical activity. Personal Soc Psychol Bull. 2018;44:332–44.CrossRef
34.
Hohl DH, Knoll N, Wiedemann A, Keller J, Scholz U, Schrader M, Burkert S. Enabling or cultivating? The role of prostate cancer patients' received partner support and self-efficacy in the maintenance of pelvic floor exercise following tumor surgery. Ann Behav Med. 2015;50:247–58.CrossRef
35.
Lewis MA, Rook KS. Social control in personal relationships: impact on health behaviors and psychological distress. Health Psychol. 1999;18:63–71.CrossRefPubMed
36.
37.
Okun MA, Huff BP, August KJ, Rook KS. Testing hypotheses distilled from four models of the effects of health-related social control. Basic Appl Soc Psych. 2007;29:185–93.CrossRef
38.
Bodenmann G, Randall AK, Falconier MK. Coping in couples: The systemic transactional model (STM). In: Falconier MK, Randall AK, Bodenmann G, Falconier MK, Randall AK, Bodenmann G, editors. Couples coping with stress: a cross-cultural perspective. New York: Routledge/Taylor & Francis Group; 2016. p. 5–22.
39.
Keller J, Burkert S, Wiedemann AU, Luszczynska A, Schrader M, Knoll N. Individual and dyadic planning predicting pelvic floor exercise among prostate cancer survivors. Rehabil Psychol. 2015;60:222–31.CrossRefPubMed
40.
Schiphof D, van den Driest JJ, Runhaar J. Osteoarthritis year in review 2017: rehabilitation and outcomes. Osteoarthr Cartil. 2018;26:326–40.CrossRefPubMed
41.
42.
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986;29:1039–49.CrossRefPubMed
43.
Ajzen I. From intentions to actions: a theory of planned behavior. In: Kuhl J, Beckmann J, editors. Action control: cognition to behavior. Berlin: Springer; 1985. p. 11–39.CrossRef
44.
45.
Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007;116:1081–93.CrossRefPubMed
46.
Scholz U, Sniehotta FF, Schüz B, Oeberst A. Dynamics in self-regulation: plan execution self-efficacy and mastery of action plans. J Appl Soc Psychol. 2007;37:2706–25.CrossRef
47.
Hautzinger M. The CES-D scale: a depression-rating scale for research in the general population. Diagnostica. 1988;34:167–73.
48.
Bellamy N. WOMAC Osteoarthritis Index User Guide, Version V. Brisbane; 2002.
49.
Mäder U, Martin BW, Schutz Y, Marti B. Validity of four short physical activity questionnaires in middle-aged persons. Med Sci Sports Exerc. 2006;38:1255–66.CrossRefPubMed
50.
Bernstein M, Sloutskis D, Kumanyika S, Sparti A, Schutz Y, Morabia A. Data-based approach for developing a physical activity frequency questionnaire. Am J Epidemiol. 1998;147:147–54.CrossRefPubMed
51.
52.
53.
Warner LM, Schüz B, Wolff JK, Parschau L, Wurm S, Schwarzer R. Sources of self-efficacy for physical activity. Health Psychol. 2014;33:1298–308.CrossRefPubMed
54.
Vlachopoulos SP, Michailidou S. Development and initial validation of a measure of autonomy, competence, and relatedness in exercise: the basic psychological needs in exercise scale. Meas Phys Educ Exerc Sci. 2006;10:179–201.CrossRef
55.
Job V, Walton GM, Bernecker K, Dweck CS. Beliefs about willpower determine the impact of glucose on self-control. Proc Natl Acad Sci U S A. 2013;110:14837–42.CrossRefPubMedPubMedCentral
56.
Ochsner S, Knoll N, Stadler G, Luszczynska A, Hornung R, Scholz U. Interacting effects of receiving social control and social support during smoking cessation. Ann Behav Med. 2015;49:141–6.CrossRefPubMed
57.
Graham JW. Missing data analysis: making it work in the real world. Ann Rev Psychol. 2009;60:549–76.CrossRef
58.
Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:–e7586.
59.
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010;1:100–7.CrossRefPubMedPubMedCentral
60.
Podsakoff PM, MacKenzie SB, Lee J-Y, Podsakoff NP. Common method biases in behavioral research: a critical review of the literature and recommended remedies. J Appl Psychol. 2003;88:879–903.CrossRefPubMed
61.
Ajzen I. The directive influence of attitudes on behavior. In: Gollwitzer PM, Bargh JA, Gollwitzer PM, Bargh JA, editors. The psychology of action: linking cognition and motivation to behavior. New York: Guilford Press; 1996. p. 385–403.
62.
Wilding S, Conner M, Sandberg T, Prestwich A, Lawton R, Wood C, Miles E, Godin G, Sheeran P. The question-behaviour effect: a theoretical and methodological review and meta-analysis. Eur Rev Soc Psychol. 2016;27:196–230.CrossRef
63.
Motl RW, McAuley E, Dlugonski D. Reactivity in baseline accelerometer data from a physical activity behavioral intervention. Health Psychol. 2012;31:172–5.CrossRefPubMed
64.
Slootmaker SM, Schuit AJ, Chinapaw MJM, Seidell JC, van Mechelen W. Disagreement in physical activity assessed by accelerometer and self-report in subgroups of age, gender, education and weight status. Int J Behav Nutr Phys Act. 2009;6:17.CrossRefPubMedPubMedCentral
65.
66.
Kenny DA, Kashy DA, Cook WL. Dyadic data analysis. New York: Guilford Press; 2006.
Metadata
Title
Facilitating physical activity and reducing symptoms in patients with knee osteoarthritis: study protocol of a randomized controlled trial to test a theory-based PrevOP-psychological adherence program (PrevOP-PAP)
Authors
Nina Knoll
Diana Hilda Hohl
Susannah Motter
Jan Keller
Daniela Lange
Dieter Felsenberg
Peter Martus
Wolfgang Ertel
Ralf Schwarzer
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2018
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-018-2158-8

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