Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— LIVELYOfficial title:
PhysicaL actIvity interVention vErsus puLmonarY Rehabilitation in COPD: The LIVELY COPD Project.
Verified date | August 2017 |
Source | University of Ulster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to assess the feasibility of conducting a trial to
investigate the effectiveness of a physical activity intervention (physical activity
consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in
improving physical activity in COPD.
Objectives are:
(i) to assess the feasibility (patient recruitment, adherence, drop-outs and adverse events)
of delivering a physical activity intervention in the COPD patient population versus
pulmonary rehabilitation; (ii) to explore users perceptions relating to satisfaction and
benefits of a physical activity intervention versus pulmonary rehabilitation; (iii) to
investigate between and within group change in physical activity, exercise capacity, quality
of life, self-efficacy and changes in the transtheoretical model with the physical activity
intervention versus pulmonary rehabilitation; and (iv) to examine the cost of delivering a
physical activity intervention versus pulmonary rehabilitation for patients with COPD.
The hypothesis for this study is that it will be feasible to conduct a trial that will
investigate the effectiveness of a physical activity intervention (physical activity
consultation and a pedometer-based walking programme) compared to pulmonary rehabilitation
for improving physical activity in COPD. The study will provide important information about
interventions designed to promote and maintain physical activity, improve patient outcomes
and increase patients' choice relating to exercise and physical activity interventions. It
will provide a rationale and data for an adequately powered clinical trial evaluating the
effects of a physical activity intervention.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 19, 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. The Patient must be referred to pulmonary rehabilitation. 2. The Patient must have a Primary diagnosis of COPD 3. The Patient must have a good understanding of written English (as reported by the individual patient) 4. The Patient must be in a stable phase (not on antibiotics at the time of assessment with the ISWT), and deemed clinically stable by the clinical pulmonary rehabilitation team. Exclusion Criteria: 1. The inability to safely take part in a walking programme or pulmonary rehabilitation (e.g. unstable angina, neurological, spinal or skeletal dysfunction affecting ability to exercise) 2. The inability to comprehend or follow instructions (e.g. dementia). 3. Clinically unstable (Pulmonary exacerbation or any change in symptoms and medication in the last 4 weeks) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast | Co Antrim |
United Kingdom | Western Health and Social Care Trust | Enniskillen |
Lead Sponsor | Collaborator |
---|---|
University of Ulster | Belfast Health and Social Care Trust, Katholieke Universiteit Leuven, Queen's University, Belfast, Western Health and Social Care Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor. | The activity monitor is worn for 7 consecutive full days prior to the intervention, and 7 full days immediately after the intervention. | Baseline and at 6-weeks for PR group and 12-weeks for PA group | |
Secondary | Change from baseline in time spent in physical activity and in sitting using the International Physical Activity Questionnaire | Baseline and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation | ||
Secondary | Change from baseline in exercise Capacity using the Incremental Shuttle Walk Test | Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation | ||
Secondary | Change from baseline in Quality of Life using the EuroQOL-5D | Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation | ||
Secondary | Change from baseline in Quality of Life using the COPD Assessment Test | Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation | ||
Secondary | Stage of change in terms of physical activity using the Stages of Change Questionnaire | The Stages of Change Questionnaire is the temporal part of the transtheoretical model. It will be used to determine the current stage of change the participant is at in terms of their physical activity behaviour. | Baseline, and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation | |
Secondary | Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire | Marcus's Self-Efficacy Questionnaire is a component of the transtheoretical model which will provide more detailed information on each individual's confidence to undertake physical activity in different situations. | Baseline and at 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation | |
Secondary | Patients' perceptions of both interventions will be obtained via semi-structured interviews. | Information will be collected with regards patient satisfaction with their exercise/activity, information regarding ease of execution, safety and tolerability of the programmes and the outcome measures, views about continuing exercise and suggestions for improving the programmes. | At 6-weeks for PR group and 12-weeks for PA group | |
Secondary | Feasibility of the interventions | For both interventions information will be collected on recruitment and retention, dropouts, adherence and adverse events which will be necessary to establish feasibility. | End of study | |
Secondary | Global Rating of Change Questionnaire | This is a numerical rating scale about their patient's perception of any change in their physical activity | At 6-weeks for PR group and 12-weeks for PA group, and follow up at 18 (PR group) and 24 (PA group) weeks post randomisation | |
Secondary | Physical activity will be assessed using step counts recorded with an Actigraph activity monitor. | At 18 (PR group) and 24 (PA group) weeks post randomisation |
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