Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind randomised implementation trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 465
- 试验地点
- 4
- 主要终点
- 1.Exercise capacity measured by the Endurance Shuttle Walking Test (ESWT) assessed post-PR intervention period.
研究概览
简要总结
Low- and middle-income countries (LMICs) account for 80% of the total burden of chronic respiratory diseases (CRDs) and mortality. CRDs are the second most common cause of all deaths in India and contributed to almost 30% of all deaths and DALYs due to CRDs globally in 2019. CRDs and their symptoms can be controlled with treatment including medications and exercises. Pulmonary rehabilitation (PR) is a well-established non-pharmacological treatment option used in management of CRDs which has shown to improve symptom control and lung function. PR is a comprehensive, multidisciplinary, individually tailored intervention that overcomes the deconditioning induced by CRDs through endurance and muscle-strengthening exercises combined with education and coping mechanisms for breathlessness. However, most of the evidence is from high-income countries. This is a multi-country implementation trial in low- and middle-income country (LMIC) settings which will evaluate the effectiveness of centre and home-based PR over usual care, besides evaluating cost effectiveness, feasibility and sustainability.
This trial will be conducted across four centres and three countries with K V Kuppam block of RUHSA department being the study setting for CMC centre in India. A total of 465 study participants (confirmed cases of CRD, diagnosed by physician) will take part in this study with 120 participants from CMC centre who will be recruited after taking written informed consent and optimisation of treatment. They will be randomised to three groups -
1. Centre-PR: a programme of exercise and education twice a week for 8 weeks at a PR Centre
2. Home-PR: a programme of exercise and education twice a week for 8 weeks in their own homes, supervised remotely by video-call/telephone
3. Usual Care: usual clinical care. At the end of the trial, this group will be offered their choice of Centre-PR or Home-PR
Before the start of PR, we will assess exercise capacity (Primary outcome) through Endurance Shuttle Walk test (ESWT) with minimum clinically important difference (MCID) of 174 seconds. The key secondary outcomes measured will be quality of life (HRQoL), breathlessness (mMRC dyspnoea scale), anxiety and depression (HADS), activities of daily living and physical activity (GPAQ). This will be repeated at 12 weeks and at 6 months to assess the impact of PR and measure whether benefits are maintained, respectively. We will measure the feasibility and acceptability through qualitative process evaluation and health economic impact through cost-effectiveness analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Assessed by referring physician as having persistent and functionally limiting respiratory symptoms (mMRC ≥2) after optimization of pharmacological therapy.
- •Resident locally and willing to engage with either Centre-PR and Home-PR schedules if randomized to either of these groups.
- •Willing and able to provide written informed consent.
排除标准
- •People with non-respiratory causes for the symptoms (stable co-morbidity may be included if clinically appropriate).
- •Active TB infection.
- •Any condition that would increase risk (e.g. uncontrolled cardiac disease) interfere with PR (e.g. neurological disorders, severe arthritis, dementia) or be inappropriate (very severe frailty, end-of-life) 4) On-going, or completed PR (including other exercise program) within previous 18 months.
- •Living in the same house as another participant.
结局指标
主要结局
1.Exercise capacity measured by the Endurance Shuttle Walking Test (ESWT) assessed post-PR intervention period.
时间窗: 1. Baseline before randomization (T0) | 2. At 12 weeks after completion of PR intervention (T+12; between 10-14 weeks) | 3. At 6 months following intervention (T+26; between 24-30 weeks)
2.HRQoL will be measured with the 50-item St Georges Respiratory Questionnaire (SGRQ).
时间窗: 1. Baseline before randomization (T0) | 2. At 12 weeks after completion of PR intervention (T+12; between 10-14 weeks) | 3. At 6 months following intervention (T+26; between 24-30 weeks)
3.Breathless will be assessed with the modified MRC Dyspnoea Scale (mMRC) ranging from 0-4.
时间窗: 1. Baseline before randomization (T0) | 2. At 12 weeks after completion of PR intervention (T+12; between 10-14 weeks) | 3. At 6 months following intervention (T+26; between 24-30 weeks)
4.The common co-morbid symptoms of anxiety and depression will be assessed with the Hospital Anxiety and Depression Score (HADS).
时间窗: 1. Baseline before randomization (T0) | 2. At 12 weeks after completion of PR intervention (T+12; between 10-14 weeks) | 3. At 6 months following intervention (T+26; between 24-30 weeks)
5.The impact of breathlessness on activities of daily living such as washing and dressing will be assessed with the London Chest Activities of Daily Living (LCADL).
时间窗: 1. Baseline before randomization (T0) | 2. At 12 weeks after completion of PR intervention (T+12; between 10-14 weeks) | 3. At 6 months following intervention (T+26; between 24-30 weeks)
6.The Global Physical Activity Questionnaire (GPAQ) assesses physical activity in the domains of work, leisure, or travel.
时间窗: 1. Baseline before randomization (T0) | 2. At 12 weeks after completion of PR intervention (T+12; between 10-14 weeks) | 3. At 6 months following intervention (T+26; between 24-30 weeks)
次要结局
未报告次要终点
研究者
Dr Biswajit Paul
Christian Medical College, Vellore