Physical Activity Following Pulmonary Rehabilitation in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-13

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Physiotherapists will be aware of the allocation of the programmes (not possible to blind) as they will be involved with delivering information/training of the intervention components. However, a researcher blinded to group allocation will perform the quantitative analysis.

Study Groups

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WhatsApp, Pedometer and Step Diary

Pedometer, step diary and WhatsApp following pulmonary rehabilitation

Group Type EXPERIMENTAL

WhatsApp, Pedometer and Step Diary

Intervention Type BEHAVIORAL

Participants will be provided with a daily step diary and added to a group chat on WhatsApp. The group chat will be populated by other members of pulmonary rehabilitation programme (cluster) and the WhatsApp group leader will encourage participants to keep active. Participants will be encouraged to record the number of steps walked in a paper diary at the end of each day (i.e. prior to bedtime). This diary will simply have three columns: day of the week; number of steps; comments (optional).

The intervention will last 52 weeks.

Control

Usual care following pulmonary rehabilitation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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WhatsApp, Pedometer and Step Diary

Participants will be provided with a daily step diary and added to a group chat on WhatsApp. The group chat will be populated by other members of pulmonary rehabilitation programme (cluster) and the WhatsApp group leader will encourage participants to keep active. Participants will be encouraged to record the number of steps walked in a paper diary at the end of each day (i.e. prior to bedtime). This diary will simply have three columns: day of the week; number of steps; comments (optional).

The intervention will last 52 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No