Improving Physical Activity in Rehabilitation

NCT03264924 | Completed

• 1 other identifier: LiverpoolHeartNHS
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac rehabilitation is a programme of exercise and health advice for people recovering from heart disease. Pulmonary rehabilitation is a similar programme for people with chronic lung disease. For both groups of patients, taking part in rehabilitation can lead to improvements in health and well-being. However, only 30% of patients complete their agreed rehabilitation programme. This costs the NHS millions of pounds every year. This project aims to investigate whether a motivational-based intervention, underpinned by self-determination theory and motivational interviewing, will enable staff to encourage more patients to take part in physical activity (PA). Staff will be trained with the new communication skills and will then deliver the rehabilitation programme. The session content will not change, just the way in which staff speak to patients. This will be a two-phase study. Phase A will take a qualitative approach collect patient and staff feedback about the current rehabilitation programme, before using this information to develop and pilot the intervention. Phase B will then assess the feasibility of the intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part in the phase B will be required to complete an interview and questionnaire at three time points. Patients' personal opinions of the programmes will be extremely important in discovering what can be done to improve rehabilitation for future participants. The main objectives will be to look at whether the intervention increases the number of patients taking part in physical activity. The investigators plan to establish how much physical activity patients take part in whilst they are in rehabilitation, as well as once they have left the programme. This is why participants will be interviewed three and six months after they have finished their rehabilitation programme.

Conditions

Cardiovascular Diseases; Pulmonary Disease; Chronic Obstructive Pulmonary Disease

Keywords

physical activity; motivation; behaviour change

Outcome Measures

Primary Outcomes (1)

• Percentage enrolment and attendance to rehabilitation

  Measure of percentage enrolment and attendance to rehabilitation.

  June 2018-February 2019.

Secondary Outcomes (9)

• Qualitative Impact Evaluation

  June 2018-February 2019. Interviews will be conducted upon discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge

• Treatment Self Regulation Questionnaire (Exercise)

  June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.

• International Physical Activity Questionnaire Short Version (IPAQ)

  June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.

• EuroQol, five dimensions, three levels (EQ-5D-3L)

  June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.

• Perceived Competence Scale (Exercising Regularly)

  June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.

Study Arms (4)

Phase A, Study One

Semi-structured interviews to investigate staff and patients' experiences of participating and facilitating cardiac and pulmonary rehabilitation.

Phase A, Study Two

Focus group with rehabilitation stakeholders to discuss perceived feasibility and acceptability of the intervention design.

Phase A, Study Three

Pilot of the intervention, using a group of exercise physiologists external to the community rehabilitation services.

Behavioral: IPAIR

Phase B

Community rehabilitation service staff will participate in the intervention. Patients will then participate in the rehabilitaiton programme. Physical activity levels of patients will be recorded throughout the rehabilitation programme and for six months post-discharge. Qualitative and quantitative follow-up sessions will patients will take place at discharge (8 weeks after start of rehabilitation), and three and six months post-discharge.

Behavioral: IPAIR

Interventions

IPAIR BEHAVIORAL

Motivational interview training

Also known as: Motivational interview training

Phase A, Study Three; Phase B

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac and pulmonary rehabilitation patients and staff.

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Edge Hill University: collaborator

Study Sites (1)

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

Related Publications (23)

• Arnold E, Bruton A, Ellis-Hill C. Adherence to pulmonary rehabilitation: A qualitative study. Respir Med. 2006 Oct;100(10):1716-23. doi: 10.1016/j.rmed.2006.02.007. Epub 2006 Mar 22.

  PMID: 16554147 BACKGROUND

• Bjarnason-Wehrens B, Bott D, Benesch L, Bischoff KO, Buran-Kilian B, Gysan D, Hollenstein U, Mayer-Berger W, Wilkniss R, Sauer G. Long-term results of a three-week intensive cardiac out-patient rehabilitation program in motivated patients with low social status. Clin Res Cardiol. 2007 Feb;96(2):77-85. doi: 10.1007/s00392-007-0461-0. Epub 2006 Dec 14.

  PMID: 17160566 BACKGROUND

• British Heart Foundation. (2015). The National Audit of Cardiac Rehabilitation Annual Statistical Report 2015. London. Retrieved from http://www.cardiacrehabilitation.org.uk/docs/2007.pdf

  BACKGROUND

• British Thoracic Society (BTS). (2013). BTS Guideline on Pulmonary Rehabilitation in Adults. An International Journal of Respiratory Medicine, 68(2), ii1-31. https://doi.org/10.1136/thoraxjnl-2013-203808

  BACKGROUND

• Chan DK, Lonsdale C, Ho PY, Yung PS, Chan KM. Patient motivation and adherence to postsurgery rehabilitation exercise recommendations: the influence of physiotherapists' autonomy-supportive behaviors. Arch Phys Med Rehabil. 2009 Dec;90(12):1977-82. doi: 10.1016/j.apmr.2009.05.024.

  PMID: 19969157 BACKGROUND

• Clark RA, Conway A, Poulsen V, Keech W, Tirimacco R, Tideman P. Alternative models of cardiac rehabilitation: a systematic review. Eur J Prev Cardiol. 2015 Jan;22(1):35-74. doi: 10.1177/2047487313501093. Epub 2013 Aug 13.

  PMID: 23943649 BACKGROUND

• De Amici D, Klersy C, Ramajoli F, Brustia L, Politi P. Impact of the Hawthorne effect in a longitudinal clinical study: the case of anesthesia. Control Clin Trials. 2000 Apr;21(2):103-14. doi: 10.1016/s0197-2456(99)00054-9.

  PMID: 10715508 BACKGROUND

• Deci, E. L., & Ryan, R. M. (2008). Facilitating optimal motivation and psychological well-being across life's domains. Canadian Psychology/Psychologie Canadienne, 49(1), 14-23. https://doi.org/10.1037/0708-5591.49.1.14

  BACKGROUND

• Hardcastle SJ, Fortier M, Blake N, Hagger MS. Identifying content-based and relational techniques to change behaviour in motivational interviewing. Health Psychol Rev. 2017 Mar;11(1):1-16. doi: 10.1080/17437199.2016.1190659. Epub 2016 Jun 2.

  PMID: 27189713 BACKGROUND

• Hospes G, Bossenbroek L, Ten Hacken NH, van Hengel P, de Greef MH. Enhancement of daily physical activity increases physical fitness of outclinic COPD patients: results of an exercise counseling program. Patient Educ Couns. 2009 May;75(2):274-8. doi: 10.1016/j.pec.2008.10.005. Epub 2008 Nov 25.

  PMID: 19036552 BACKGROUND

• Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.

  PMID: 18824488 BACKGROUND

• Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9.

  PMID: 16472039 BACKGROUND

• National Institute for Health and Clinical Excellence (NICE). (2013). Cardiac rehabilitation services: commissioning guide. London.

  BACKGROUND

• Ntoumanis N, Thogersen-Ntoumani C, Quested E, Hancox J. The effects of training group exercise class instructors to adopt a motivationally adaptive communication style. Scand J Med Sci Sports. 2017 Sep;27(9):1026-1034. doi: 10.1111/sms.12713. Epub 2016 Jun 10.

  PMID: 27283879 BACKGROUND

• Prestwich, A., Webb, T. L., & Conner, M. (2015). Using theory to develop and test interventions to promote changes in health behaviour: Evidence, issues, and recommendations. Current Opinion in Psychology, 5(February), 1-5. https://doi.org/10.1016/j.copsyc.2015.02.011

  BACKGROUND

• Rahman RJ, Thogersen-Ntoumani C, Thatcher J, Doust J. Changes in need satisfaction and motivation orientation as predictors of psychological and behavioural outcomes in exercise referral. Psychol Health. 2011 Nov;26(11):1521-39. doi: 10.1080/08870446.2010.538849. Epub 2011 Jun 16.

  PMID: 22111661 BACKGROUND

• Russell KL, Bray SR. Promoting self-determined motivation for exercise in cardiac rehabilitation: the role of autonomy support. Rehabil Psychol. 2010 Feb;55(1):74-80. doi: 10.1037/a0018416.

  PMID: 20175637 BACKGROUND

• Silva MN, Vieira PN, Coutinho SR, Minderico CS, Matos MG, Sardinha LB, Teixeira PJ. Using self-determination theory to promote physical activity and weight control: a randomized controlled trial in women. J Behav Med. 2010 Apr;33(2):110-22. doi: 10.1007/s10865-009-9239-y. Epub 2009 Dec 11.

  PMID: 20012179 BACKGROUND

• Singh SJ, Smith DL, Hyland ME, Morgan MD. A short outpatient pulmonary rehabilitation programme: immediate and longer-term effects on exercise performance and quality of life. Respir Med. 1998 Sep;92(9):1146-54. doi: 10.1016/s0954-6111(98)90410-3.

  PMID: 9926171 BACKGROUND

• Speake H, Copeland RJ, Till SH, Breckon JD, Haake S, Hart O. Embedding Physical Activity in the Heart of the NHS: The Need for a Whole-System Approach. Sports Med. 2016 Jul;46(7):939-46. doi: 10.1007/s40279-016-0488-y.

  PMID: 26942468 BACKGROUND

• Teixeira PJ, Carraca EV, Markland D, Silva MN, Ryan RM. Exercise, physical activity, and self-determination theory: a systematic review. Int J Behav Nutr Phys Act. 2012 Jun 22;9:78. doi: 10.1186/1479-5868-9-78.

  PMID: 22726453 BACKGROUND

• The Academy of Medical Royal Colleges. (2015). Exercise: The miracle cure and the role of the doctor in promoting it. Report from the Academy of Medical Royal Colleges. London. Retrieved from http://www.aomrc.org.uk

  BACKGROUND

• Yohannes AM, Doherty P, Bundy C, Yalfani A. The long-term benefits of cardiac rehabilitation on depression, anxiety, physical activity and quality of life. J Clin Nurs. 2010 Oct;19(19-20):2806-13. doi: 10.1111/j.1365-2702.2010.03313.x. Epub 2010 Aug 24.

  PMID: 20738450 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Adrian W Midgley, PhD

  Liverpool Heart and Chest Hospital NHS Foundation Trust/ Edge Hill University

  PRINCIPAL INVESTIGATOR

• Bashir Matata, PhD

  Liverpool Heart and Chest Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: August 29, 2017
• Study Start: July 24, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: February 20, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)