Physical Activity Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- University of Lincoln
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Acceptability of the intervention
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of this feasibility study is to identify the acceptability of an intervention designed to promote physical activity following pulmonary rehabilitation for individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants in the intervention group will be provided with pedometers and step diaries and added to a WhatsApp group with other graduates of pulmonary rehabilitation for 52 weeks.
Detailed Description
Evidence suggests that physical activity is not maintained following pulmonary rehabilitation for individuals with COPD. Peer social support, feedback about physical progression and recognition of opportunities to stay active following pulmonary rehabilitation have been identified as facilitators to physical activity following pulmonary rehabilitation. The proposed feasibility study has incorporated these factors into the intervention. This is a mixed-methods study including a feasibility cluster randomised controlled trial and a qualitative process evaluation. Clusters will be pulmonary rehabilitation programmes across Lincolnshire Community Health Services, NHS Trust (n=8), randomly allocated to the Intervention or Control. Patients in the Intervention group will receive a multi component intervention following pulmonary rehabilitation (pedometer, step diary and WhatsApp) and patients in the Control group will receive standard care following pulmonary rehabilitation. The primary objective is to identify and report the acceptability of the intervention for patients. The secondary objectives are to: 1) gather information on recruitment and consent rates of patients who are eligible and willing to participate, and to monitor retention of participants throughout the study; 2) understand the patients' and health care professionals' experience and views of the intervention and research procedures; 3) identify and report intervention fidelity throughout the study; 4) provide an estimate of likely changes in the proposed primary outcome for the full randomised controlled trial (average daily step count at 52 weeks following pulmonary rehabilitation) and other secondary health outcomes; 5) obtain the necessary statistical parameters to inform sample size calculations in a future definitive cluster randomised controlled trial. The results from the feasibility study will inform the design of a definitive trial, including whether the specific intervention has the potential to promote physical activity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cluster level
- •Pulmonary rehabilitation programmes within Lincolnshire Community Health Services (NHS trust).
- •Permission from the lead healthcare professionals of the pulmonary rehabilitation programme for the programme to be involved in the study.
- •Patient level
- •Adults (age range: 30-100 years) with COPD who are enrolled in pulmonary rehabilitation within Lincolnshire Community Health Services (NHS trust).
- •Provide informed consent for their outcome data to be collected.
- •Patients (for telephone interviews)
- •Have access to a telephone.
- •Adults (age range: 30-100 years) with COPD who are enrolled in pulmonary rehabilitation within Lincolnshire community health services (NHS trust).
- •Provide informed consent to participate in a telephone interview (including patients who do/do not consent for their outcome data to be collected).
Exclusion Criteria
- •Cluster level
- •Pulmonary rehabilitation programmes which are not within Lincolnshire Community Health Services (NHS trust).
- •The lead health care professionals of the pulmonary rehabilitation programmes are unwilling for the programme to be involved in the study.
- •Patient level
- •Not enrolled on a pulmonary rehabilitation programme within Lincolnshire Community Health Services (NHS trust) or those who drop out of pulmonary rehabilitation following enrolment.
- •Unable/unwilling to provide informed consent for their outcome data to be collected.
- •Involved in another research study including the use of an intervention to promote physical activity.
- •Patients (telephone interviews)
- •Do not have access to a telephone.
- •Not enrolled on a pulmonary rehabilitation programme within Lincolnshire Community Health Services (NHS trust) or those who drop out of pulmonary rehabilitation following enrolment.
Outcomes
Primary Outcomes
Acceptability of the intervention
Time Frame: 55 weeks
The number of patients who comply with the intervention will be measured
Secondary Outcomes
- Recruitment rates(Up to 26 weeks (approximately))
- Consent rates(Up to 26 weeks (approximately))
- Attrition rates(Up to 55 weeks (study completion))
- Semi-structured telephone interviews with subsets of patients(At relevant intervals up to 55 weeks (study completion))
- Focus groups with health care professionals(At relevant intervals up to 55 weeks (study completion))
- Content of anonymised WhatsApp chat(At 4 week intervals, up to 55 weeks (study completion))
- WhatsApp Checklist(At 4 week intervals, up to 55 weeks (study completion))
- Step diary (self-reported)(55 weeks (study completion))
- Activity levels(During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation)
- PROactive tool(During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation)
- Sleep levels(Baseline, 12 and 52 weeks after pulmonary rehabilitation)
- Sleep (self-reported sleep habits)(During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation)
- Incremental Shuttle Walk Test (ISWT)(During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation)
- Chronic Respiratory Questionnaire (CRQ)(During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation)
- Hospital Anxiety and Depression Scale (HADS)(During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation)