PhysicaL actIvity interVention vErsus puLmonarY Rehabilitation in COPD: The LIVELY COPD Project.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Patient must be referred to pulmonary rehabilitation.
- •The Patient must have a Primary diagnosis of COPD
- •The Patient must have a good understanding of written English (as reported by the individual patient)
- •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.
排除标准
- •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)
- •The inability to comprehend or follow instructions (e.g. dementia).
- •Clinically unstable (Pulmonary exacerbation or any change in symptoms and medication in the last 4 weeks)
研究组 & 干预措施
Physical Activity Intervention
12 week home-based walking programme consisting of weekly physical activity consultations and a pedometer-driven walking programme
干预措施: Physical Activity Intervention (Behavioral)
Pulmonary Rehabilitation Programme
6-week supervised outpatient programme consisting of twice-weekly exercise sessions and once-weekly education sessions.
干预措施: Pulmonary Rehabilitation Programme (Behavioral)
结局指标
主要结局
Change from baseline in physical activity will be assessed using step counts recorded with an Actigraph activity monitor.
时间窗: Baseline and at 6-weeks for PR group and 12-weeks for PA group
The activity monitor is worn for 7 consecutive full days prior to the intervention, and 7 full days immediately after the intervention.
次要结局
- Stage of change in terms of physical activity using the Stages of Change 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)
- Confidence to undertake physical activity using Marcus's Self-Efficacy 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)
- 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)
- Patients' perceptions of both interventions will be obtained via semi-structured interviews.(At 6-weeks for PR group and 12-weeks for PA group)
- Global Rating of Change Questionnaire(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)
- 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)
- 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)
- 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)
- 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)
- Feasibility of the interventions(End of study)
研究者
Brenda O'Neill
Senior Lecturer in Physiotherapy
University of Ulster