Clinical trial NCT03660644: Physical Activity Following Pulmonary Rehabilitation in COPD
Official title: Physical Activity Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Physical Activity
Keywords: COPD
Physical Activity
Pulmonary rehabilitation
Lead sponsor: University of Lincoln
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
name: British Lung Foundation
name: University College, London
name: University of Oxford
First posted: 2018-09-06
Enrollment: 74
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Health care professionals

* Involved in delivering the pulmonary rehabilitation programmes allocated to the Intervention Group within Lincolnshire Community Health Services (NHS trust).
* Provide informed consent to participate in a focus group.

WhatsApp group leaders

* Volunteers (who were members of local COPD support groups, whom held the position of Chair, Treasurer or Secretary, or were ordinary members, and in general, sufficiently stable to be a proactive and regular member of the group)
* Provide informed consent to lead the WhatsApp groups.

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.
* Unable/unwilling to provide informed consent to participate in a telephone interview.

Health care professionals

* Not involved in delivering the pulmonary rehabilitation programmes allocated to the Intervention Group.
* Unable/unwilling to provide informed consent to participate in a focus group.

WhatsApp group leaders

* Not volunteers (and have not been involved in local COPD support groups, have not held the position of Chair, Treasurer or Secretary, have not been ordinary members, and in general, are not sufficiently stable to be a proactive and regular member of the group)
* Unable/unwilling to provide informed consent to lead the WhatsApp groups.

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: 55 weeks
Secondary outcomes:
measure: Recruitment rates
timeFrame: Up to 26 weeks (approximately)
measure: Consent rates
timeFrame: Up to 26 weeks (approximately)
measure: Attrition rates
timeFrame: Up to 55 weeks (study completion)
measure: Semi-structured telephone interviews with subsets of patients
timeFrame: At relevant intervals up to 55 weeks (study completion)
measure: Focus groups with health care professionals
timeFrame: At relevant intervals up to 55 weeks (study completion)
measure: Content of anonymised WhatsApp chat
timeFrame: At 4 week intervals, up to 55 weeks (study completion)
measure: WhatsApp Checklist
timeFrame: At 4 week intervals, up to 55 weeks (study completion)
measure: Step diary (self-reported)
timeFrame: 55 weeks (study completion)
measure: Activity levels
timeFrame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
measure: PROactive tool
timeFrame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
measure: Sleep levels
timeFrame: Baseline, 12 and 52 weeks after pulmonary rehabilitation
measure: Sleep (self-reported sleep habits)
timeFrame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
measure: Incremental Shuttle Walk Test (ISWT)
timeFrame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
measure: Chronic Respiratory Questionnaire (CRQ)
timeFrame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: NHS pulmonary rehabilitation clinics across Lincolnshire
state: Lincolnshire
Study officials:
affiliation: University of Lincoln
name: Hayley Robinson, MSc
role: PRINCIPAL_INVESTIGATOR
References: