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BMC Cardiovascular Disorders
Published in: BMC Cardiovascular Disorders 1/2017

Open Access 01-12-2017 | Study protocol

The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) – the study protocol of a randomised, controlled trial

Authors: Sabina Borg, Birgitta Öberg, Lennart Nilsson, Anne Söderlund, Maria Bäck

Published in: BMC Cardiovascular Disorders | Issue 1/2017

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Abstract

Background

To help patients with coronary artery disease (CAD) benefit from the positive health effects attained by exercise-based cardiac rehabilitation (CR), adherence to these programmes according to international guidelines is important. Strategies to increase adherence to exercise-based CR are mainly an unexplored area. The objective of this study is to investigate the effects of a behavioural medicine intervention in physiotherapy, containing goal-setting, self-monitoring and feedback, with the aim of improving rehabilitation outcomes for exercise-based CR, compared with usual care.

Methods

This is a randomised, controlled trial. A total of 160 patients with CAD will be included consecutively at the Coronary Care Unit at a university hospital in Sweden. Patients are randomised 1:1 using sealed envelopes to usual care or a behavioural medicine intervention in physiotherapy, in addition to usual care for 4 months. Outcome assessment at baseline, 4 and 12 months includes submaximal aerobic capacity (primary outcome), exercise adherence, muscle endurance, level of physical activity, biomarkers, anxiety and depression, health-related quality of life, patient enablement and self-efficacy (secondary outcomes).

Discussion

This is the first study to evaluate the role of an integrated behavioural medicine intervention in exercise-based CR in the effects of rehabilitation outcomes. The results of this study will provide valuable information about the effect of these interventions in exercise-based CR and it has the potential to inform and assist in further treatment in secondary prevention for patients with CAD.

Trial registration

The study include all items from the World Health Organization Trial Registration Data Set. Trial registration number: NCT02895451, 2016-08-16, retrospectively registered.
Literature
1.
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, et al. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014;129(3):399–410.CrossRefPubMed
2.
Bjorck L, Rosengren A, Bennett K, Lappas G, Capewell S. Modelling the decreasing coronary heart disease mortality in Sweden between 1986 and 2002. Eur Heart J. 2009;30(9):1046–56.CrossRefPubMed
3.
Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, Giles WH, Capewell S. Explaining the decrease in U.S. deaths from coronary disease, 1980-2000. New England J Med. 2007;356(23):2388–98.CrossRef
4.
Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D, American Heart Association Exercise CR, et al. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association exercise, cardiac rehabilitation, and prevention committee, the council on clinical Cardiology; the councils on cardiovascular nursing, epidemiology and prevention, and nutrition, physical activity, and metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007;115(20):2675–82.CrossRefPubMed
5.
Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, et al. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013;128(8):873–934.CrossRefPubMed
6.
Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep (Washington, DC : 1974). 1985;100(2):126–31.
7.
Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016;1:CD001800.
8.
Lawler PR, Filion KB, Eisenberg MJ. Efficacy of exercise-based cardiac rehabilitation post-myocardial infarction: a systematic review and meta-analysis of randomized controlled trials. Am Heart J. 2011;162(4):571–584.e572.CrossRefPubMed
9.
Whalley B, Thompson DR, Taylor RS. Psychological interventions for coronary heart disease: cochrane systematic review and meta-analysis. Int J Behav Med. 2014;21(1):109–21.CrossRefPubMed
10.
Kavanagh T, Mertens DJ, Hamm LF, Beyene J, Kennedy J, Corey P, Shephard RJ. Prediction of long-term prognosis in 12 169 men referred for cardiac rehabilitation. Circulation. 2002;106(6):666–71.CrossRefPubMed
11.
Conraads VM, Deaton C, Piotrowicz E, Santaularia N, Tierney S, Piepoli MF, Pieske B, Schmid JP, Dickstein K, Ponikowski PP, et al. Adherence of heart failure patients to exercise: barriers and possible solutions: a position statement of the study group on exercise training in heart failure of the heart failure Association of the European Society of Cardiology. Eur J Heart Fail. 2012;14(5):451–8.CrossRefPubMed
12.
Karmali KN, Davies P, Taylor F, Beswick A, Martin N, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2014;6:Cd007131.
13.
Sharp J, Freeman C. Patterns and predictors of uptake and adherence to cardiac rehabilitation. J Cardiopulmonary Rehabilitation Prev. 2009;29(4):241–7.CrossRef
14.
Jernberg T. SWEDEHEART årsrapport 2016. In: Matador kommunikation AB; 2016.
15.
Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009;28(6):690–701.CrossRefPubMed
16.
Moher D, Schulz KF, Altman D, Group C. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005;1(1):40–5.CrossRef
17.
Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982;92(1):111–35.PubMed
18.
19.
Bandura A. Social cognitive theory of self-regulation. Organizational Behav Hum Decision Processes. 1991;50:248–87.CrossRef
20.
Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health Psychol. 2008;27(3):379–87.CrossRefPubMed
21.
Guiraud T, Granger R, Gremeaux V, Bousquet M, Richard L, Soukarie L, Babin T, Labrunee M, Sanguignol F, Bosquet L, et al. Telephone support oriented by accelerometric measurements enhances adherence to physical activity recommendations in noncompliant patients after a cardiac rehabilitation program. Arch Phys Med Rehabil. 2012;93(12):2141–7.CrossRefPubMed
22.
Chen KY, Janz KF, Zhu W, Brychta RJ. Redefining the roles of sensors in objective physical activity monitoring. Med Sci Sports Exerc. 2012;44(1 Suppl 1):S13–23.CrossRefPubMedPubMedCentral
23.
Bassett DR Jr, Rowlands A, Trost SG. Calibration and validation of wearable monitors. Med Sci Sports Exerc. 2012;44(1 Suppl 1):32–8.CrossRef
24.
Duncan K, Pozehl B, Norman JF, Hertzog M. A self-directed adherence management program for patients with heart failure completing combined aerobic and resistance exercise training. Applied nursing research : ANR. 2011;24(4):207–14.CrossRefPubMed
25.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1(8476):307–10.CrossRefPubMed
26.
Exercise tests in relation to cardiovascular function. Report of a WHO meeting. World Health Organization Tech Rep Ser 1968, 388:1-30.
27.
Michelsen S. Reproducibility of cumulative work, heart rate and blood pressure response during stepwise versus continuous load increment during a maximal bicycle ergometer test. Scand J Clin Lab Invest. 1990;50(4):409–15.CrossRefPubMed
28.
Borg G. Borg's perceived exertion and pain scales. Champaign: Human Kinetics; 1998.
29.
Cider A, Carlsson S, Arvidsson C, Andersson B, Sunnerhagen KS. Reliability of clinical muscular endurance tests in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2006;5(2):122–6.CrossRefPubMed
30.
31.
Butte NF, Ekelund U, Westerterp KR. Assessing physical activity using wearable monitors: measures of physical activity. Med Sci Sports Exerc. 2012;44(1 Suppl 1):S5–12.CrossRefPubMed
32.
33.
Plasqui G, Westerterp KR. Physical activity assessment with accelerometers: an evaluation against doubly labeled water. Obesity (Silver Spring, Md). 2007;15(10):2371–9.CrossRef
34.
Santos-Lozano A, Marin PJ, Torres-Luque G, Ruiz JR, Lucia A, Garatachea N. Technical variability of the GT3X accelerometer. Med Eng Phys. 2012;34(6):787–90.CrossRefPubMed
35.
Bouchard C, Tremblay A, Leblanc C, Lortie G, Savard R, Theriault G. A method to assess energy expenditure in children and adults. Am J Clin Nutr. 1983;37(3):461–7.PubMed
36.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRefPubMed
37.
Norris CM, Ljubsa A, Hegadoren KM. Gender as a determinant of responses to a self-screening questionnaire on anxiety and depression by patients with coronary artery disease. Gender Med. 2009;6(3):479–87.CrossRef
38.
Stafford L, Berk M, Jackson HJ. Validity of the hospital anxiety and depression scale and patient health questionnaire-9 to screen for depression in patients with coronary artery disease. Gen Hosp Psychiatry. 2007;29(5):417–24.CrossRefPubMed
39.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–83.CrossRefPubMed
40.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol group. Ann Med. 2001;33(5):337–43.CrossRefPubMed
41.
Failde I, Ramos I. Validity and reliability of the SF-36 health survey questionnaire in patients with coronary artery disease. J Clin Epidemiol. 2000;53(4):359–65.CrossRefPubMed
42.
Schweikert B, Hahmann H, Leidl R. Validation of the EuroQol questionnaire in cardiac rehabilitation. Heart. 2006;92(1):62–7.CrossRefPubMed
43.
Roost M, Zielinski A, Petersson C, Strandberg EL. Reliability and applicability of the patient enablement instrument (PEI) in a Swedish general practice setting. BMC Fam Pract. 2015;16:31.CrossRefPubMedPubMedCentral
44.
Resnick B, Jenkins LS. Testing the reliability and validity of the self-efficacy for exercise scale. Nurs Res. 2000;49(3):154–9.CrossRefPubMed
45.
Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS: Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016;(1):Cd001800. doi:10.​1002/​14651858.​CD001800.​pub3.
46.
Cederbom S, Rydwik E, Soderlund A, Denison E, Frandin K, von Heideken WP. A behavioral medicine intervention for older women living alone with chronic pain - a feasibility study. Clin Interv Aging. 2014;9:1383–97.CrossRefPubMedPubMedCentral
47.
Holm S, Ljungman G, Asenlof P, Linton SJ, Soderlund A. Treating youth in pain: comparing tailored behavioural medicine treatment provided by physical therapists in primary care with physical exercises. Eur J Pain. 2016;20(4):626–38.CrossRefPubMed
Metadata
Title
The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) – the study protocol of a randomised, controlled trial
Authors
Sabina Borg
Birgitta Öberg
Lennart Nilsson
Anne Söderlund
Maria Bäck
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2017
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-017-0557-7

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