Clinical trial NCT02161393: Physical Activity Versus Pulmonary Rehabilitation in COPD
Official title: PhysicaL actIvity interVention vErsus puLmonarY Rehabilitation in COPD: The LIVELY COPD Project.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Physical Activity
Pulmonary Rehabilitation
Chronic obstructive pulmonary disease
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: Western Health and Social Care Trust
name: Queen's University, Belfast
name: KU Leuven
First posted: 2014-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A survey of pulmonary rehabilitation programmes mirrored the results of other UK studies and highlighted that there are not enough programmes available; currently in the UK less than 1.5% of patients with COPD receive pulmonary rehabilitation per year. Only a proportion of patients are targeted i.e. those with moderate to severe disease. The majority of programmes are outpatient-based and are supervised by clinicians. This structured and supervised format of pulmonary rehabilitation does not meet the needs of all patients with high numbers of dropouts and non-adherence; yet alternative options for increasing physical activity for patients with COPD currently do not seem to be offered.

A home-based pedometer-driven walking intervention offers an alternative method of delivering physical activity training that could be provided to larger numbers of patients, at a lower cost and with flexibility around life commitments. It would also provide patients with more choice when deciding whether to participate in exercise or physical activity.

To date no study has compared a home-based walking intervention to structured, supervised pulmonary rehabilitation or the patient preferences or cost of the two programmes. For this reason, there is a need to compare a home-based-walking intervention to the standard method of providing patients with physical activity training, i.e. pulmonary rehabilitation. Therefore this study is essential as it will assess the feasibility of conducting a trial to investigate the efficacy of a physical activity intervention (physical activity consultation and a pedometer-based walking programme) versus pulmonary rehabilitation in improving physical activity in COPD.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
timeFrame: Baseline and at 6-weeks for PR group and 12-weeks for PA group
Secondary outcomes:
measure: Change from baseline in time spent in physical activity and in sitting using the International Physical Activity Questionnaire
timeFrame: 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
measure: Change from baseline in exercise Capacity using the Incremental Shuttle Walk Test
timeFrame: 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
measure: Change from baseline in Quality of Life using the EuroQOL-5D
timeFrame: 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
measure: Change from baseline in Quality of Life using the COPD Assessment Test
timeFrame: 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
measure: Stage of change in terms of physical activity using the Stages of Change Questionnaire
timeFrame: 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
measure: Confidence to undertake physical activity using Marcus's Self-Efficacy Questionnaire
timeFrame: 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
measure: Patients' perceptions of both interventions will be obtained via semi-structured interviews.
timeFrame: At 6-weeks for PR group and 12-weeks for PA group
measure: Feasibility of the interventions
timeFrame: End of study
measure: Global Rating of Change Questionnaire
timeFrame: 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
measure: Physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
timeFrame: At 18 (PR group) and 24 (PA group) weeks post randomisation
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
state: Co Antrim
city: Enniskillen
country: United Kingdom
facility: Western Health and Social Care Trust
Study officials:
affiliation: University of Ulster
name: Brenda O'Neill, PhD
role: PRINCIPAL_INVESTIGATOR
References: