NHS pulmonary rehabilitation clinics across Lincolnshire
Lincoln, Lincolnshire, United Kingdom
NCT Number: NCT03660644
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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Notify Me30 year–100 year
All sexes
Interventional
Not applicable
Lincoln, Lincolnshire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cluster level
Patient level
Patients (for telephone interviews)
Health care professionals
WhatsApp group leaders
Exclusion criteria
Cluster level
Patient level
Patients (telephone interviews)
Health care professionals
WhatsApp group leaders
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.
Time frame: 55 weeks
The number of patients who comply with the intervention will be measured
Time frame: Up to 26 weeks (approximately)
The time taken to achieve planned sample size (clusters, participants) will be measured
Time frame: Up to 26 weeks (approximately)
The number of eligible patients willing to consent to take part in the study will be measured
Time frame: Up to 55 weeks (study completion)
The number of patients who withdraw from the study will be measured
Time frame: At relevant intervals up to 55 weeks (study completion)
Patients' experience/views of the research procedures and intervention will be measured
Time frame: At relevant intervals up to 55 weeks (study completion)
Healthcare professionals' experience/views of the research procedures and intervention will be measured
Time frame: At 4 week intervals, up to 55 weeks (study completion)
The WhatsApp chats will be sent to the research team to measure intervention fidelity.
Time frame: At 4 week intervals, up to 55 weeks (study completion)
The WhatsApp checklists will be sent to the research team to measure the intervention fidelity.
Time frame: 55 weeks (study completion)
Patients' step diaries will be collected to assess the intervention fidelity.
Time frame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
Activity levels will be measured by an activity monitor (Actigraph wGT3X-BT). Physical activity will be specified for:
Time frame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
The PROactive tool measures both physical activity amount (from the activity monitor) and physical activity difficulty to compute a reliable measure of physical activity in COPD.
Time frame: Baseline, 12 and 52 weeks after pulmonary rehabilitation
Sleep will be measured by an activity monitor (Actigraph wGT3X-BT).
Sleep will be specified for:
Time frame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
In conjunction with wearing an activity monitor, participants will report the:
Time frame: During pulmonary rehabilitation (baseline), 12 and 52 weeks after pulmonary rehabilitation
The ISWT will measure participants functional capacity.
Time frame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
The CRQ will measure patients' disease specific quality of life.
Time frame: During pulmonary rehabilitation (baseline); 12 and 52 weeks after pulmonary rehabilitation
HADS will measure patients' psychological well-being.
University of Lincoln
Other
Physical Activity Following Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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