The Efficacy of a Physical Activity Enhancing Programme Using Activity Monitors With Set Targets and Feedback for Enhancing Physical Activity Levels in Patients With COPD Attending Pulmonary Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from Baseline in Physical Activity in Daily Life (PADL) levels at 12 weeks.
研究概览
简要总结
Patients with Chronic Obstructive Pulmonary Disease are characterised by a sedentary lifestyle. This contributes to increase the number of hospitalizations and mortality. Changing this lifestyle is a major objective of the management of these patients. Pulmonary rehabilitation helps patients to increase their fitness, but modifying a longstanding sedentary habit is more difficult to achieve. This project aims at modifying patients' long term physical activity with a physical activity coaching programme. This will help patients to transform the benefits of pulmonary rehabilitation into a healthier active lifestyle and contribute to reduce hospitalizations, increase quality of life and survival.
详细描述
Study Design:
For logistical purposes, the study is divided into two work packages (WP): 1) Pilot study of DirectLife activity monitor in the daily routine of patients with COPD (WP1), which is a cross-sectional study; 2) Physical activity enhancing programme - main project (WP2), which is a randomized controlled trial. Both studies will be performed at Leith's Community Treatment Centre (LCTC) and its satellites (Midlothian Community Hospital (Bonnyrigg) & St Johns Hospital (Livingston) - Edinburgh). Only patients with COPD referred to pulmonary rehabilitation at LCTC and its satellites will be recruited for this study. The standard care treatment (exercise training) is exactly the same in all sites, and it is delivered by the same team of physiotherapists.At the satellite units it would still be the direct care that approach the participants. The recruiting procedure will be the same as that of the original study.
Written and signed consent will be taken prior to the inclusion of each patient. The study will explain the protocol and all the procedures they may undergo during study period before they sign the informed consent. With at least 24 hours in advance and before considering patients to take part in the study, we will send them the patient information sheet explaining the project and all the procedures involved.
WP1: This WP aims at establishing the best wearing position of the DirectLife activity monitor in 20 patients with COPD in their daily routine at home. As the DirectLife was only validated in healthy subjects, this is an important step to understand how this device works in daily routine, which is the best position to wear it, and also how feasible it is to use in patients with COPD.
This WP will be conducted prior to the beginning of WP2 and participants will sign a consent form to participate in the study. Twenty COPD patients will undertake the following assessments: pulmonary function (spirometry), exercise capacity (ISWT and ESWT), quality of life (CRQ), dyspnoea sensation (MRC scale) and physical activity in daily life.
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
- None
入排标准
- 年龄范围
- 30 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2013) referred for pulmonary rehabilitation;
- •Clinical stability concerning pulmonary infections or acute exacerbations within last four weeks;
- •Absence of recent Myocardial Infarction (within last 3 months), unstable angina, other significant cardiac problems, SBP > 180 mmHg, DBP > 100 mmHg or tachycardia (higher than 100 bpm);
- •Absence of significant orthopaedic, neurological, cognitive and/or psychiatric impairment restricting mobility;
- •Not following any exercise programme in the last 6 months.
排除标准
- •Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator;
- •Respiratory diseases other than COPD (e.g. asthma);
- •COPD exacerbations within 4 weeks prior to Visit 1;
- •Cognitive impairment and inability to give informed consent, as judged by the investigator;
- •Involvement in the planning and/or conduct of the study;
- •Participants should not be taking part in any other studies.
研究组 & 干预措施
Physical activity enhancing programme
Usual care + physical activity enhancing programme (PAEP) (Study group, [S]), which includes both pulmonary rehabilitation programme plus the PAEP using an activity monitor (DirectLife) with set targets of physical activity levels to stimulate and increase physical activity in daily life.
干预措施: Physical activity enhancing programme (Behavioral)
Control
Usual care (control, [C]) that includes only the pulmonary rehabilitation programme with the use of an activity monitor (DirectLife) in daily routine without any feedback or incentive to increase physical activity in daily life.
干预措施: Usual care (Other)
结局指标
主要结局
Change from Baseline in Physical Activity in Daily Life (PADL) levels at 12 weeks.
时间窗: 12 weeks
The assessment of physical activity in daily life will be conducted with a validated activity monitor to assess physical activity levels (PAL) in patients with COPD, the triaxial Actigraph GT3x accelerometer. This is a small (4.6cm x 3.3cm x 1.5cm), lightweight (19 grams) and portable device that is worn around the hip to assess movement and provide several outputs reflecting PADL (i.e. raw acceleration, energy expenditure, MET rates, steps taken, physical activity intensity, subject position) by its triaxial sensor, tracking the body motion every time subjects move up, down, forwards, backwards and sideways. By measuring the acceleration of these movements, it calculates how much energy subjects used to make them. The device will be used by the patients for at least 10 hours/day during the evaluation period of one week simultaneously with the baseline assessment of PAL conducted by the DirectLife.
Change from Baseline in Physical Activity in Daily Life (PADL) levels at 24 weeks.
时间窗: 24 weeks
The assessment of physical activity in daily life will be conducted with a validated activity monitor to assess physical activity levels (PAL) in patients with COPD, the triaxial Actigraph GT3x accelerometer. This is a small (4.6cm x 3.3cm x 1.5cm), lightweight (19 grams) and portable device that is worn around the hip to assess movement and provide several outputs reflecting PADL (i.e. raw acceleration, energy expenditure, MET rates, steps taken, physical activity intensity, subject position) by its triaxial sensor, tracking the body motion every time subjects move up, down, forwards, backwards and sideways. By measuring the acceleration of these movements, it calculates how much energy subjects used to make them. The device will be used by the patients for at least 10 hours/day during the evaluation period of one week simultaneously with the baseline assessment of PAL conducted by the DirectLife.
次要结局
- Change from Baseline in Exercise Capacity at 24 weeks.(24 weeks)
- Change from Baseline in Peripheral Muscle Strength at 12 weeks.(12 weeks)
- Change from Baseline in Health Related Quality of Life (HRQoL) at 12 weeks.(12 weeks)
- Change from Baseline in Peripheral Muscle Strength at 24 weeks.(24 weeks)
- Change from Baseline in Health Related Quality of Life (HRQoL) at 24 weeks.(24 weeks)
- Change from Baseline in Degree of Dyspnoea at 12 weeks.(12 weeks)
- Change from Baseline in Exercise Capacity at 12 weeks.(12 weeks)
- Change from Baseline in Degree of Dyspnoea at 24 weeks.(24 weeks)
- Change from Baseline in Anxiety and Depression levels at 12 weeks.(12 weeks)
- Change from Baseline in psychological status at 12 weeks(12 weeks)
- Change from Baseline in psychological status at 24 weeks(24 weeks)
- Change from Baseline in Systemic inflammation at 12 weeks(12 weeks)
- Change from Baseline in Acute Exacerbation rate at 12 weeks.(12 weeks.)
- Change from Baseline in Acute Exacerbations rate at 24 weeks.(24 weeks.)
- Change from Baseline in Anxiety and Depression levels at 24 weeks.(24 weeks)