Relative Effect of Home-based Telerehabilitation Compared to Center-based Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease: A Multicenter Randomized Controlled Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Endurance time
研究概览
简要总结
Background and study aims:
Chronic obstructive pulmonary disease is a leading cause of mortality worldwide. Pulmonary rehabilitation is recommended for patients to improve dyspnea, exercise capacity, and quality of life. Paradoxically, as few as 5 to 10% of eligible patients undergo pulmonary rehabilitation due to barriers such as transportation difficulties and limited availability of pulmonary rehabilitation centers. Home-based pulmonary rehabilitation using advanced telehealth technologies (telerehabilitation) may offer a solution to improve access.
This study aims to compare the relative effectiveness of a home-based telerehabilitation program with center-based program. The primary objective is to assess changes in exercise endurance capacity, measured by endurance time, before and after participation of the rehabilitation program.
Who can participate?
Adults between 45 and 80 years old who are referred for pulmonary rehabilitation and have a confirmed diagnosis of chronic obstrucitve pulmonary disease (GOLD stage II to IV) at any of the participating centers are eligible to participate, whether or not they use oxygen during exercise. Participants must live at home with another adult who is present during exercise sessions. They must not have experienced any exacerbation in the month prior to study inclusion, nor have participated in a pulmonary rehabilitation program within the past year. Participants must not have any scheduled surgery within the next four months, including surgery for lung cancer resection. They must not have active cancer, and must not present any contraindication to exercise or any condition that would limit their ability to use the telerehabilitation system.
Eligible participants must be beneficiaries of a social security system and must have read and understood the information letter and signed the informed consent form.
What does the study involve?
This is a multi-center, randomized controlled trial with two groups:
Center-based rehabilitation group: Participants will attend 24 sessions over eight weeks (three sessions per week) at the center. The program includes an initial session of therapeutic education and exercise training, followed by 24 rehabilitation sessions, and a final assessment with educational reinforcement.
Home-based rehabilitation group: Participants will have 24 sessions at home over the same period (eight weeks). The program includes an initial in-center assessment session, followed by 24 rehabilitation sessions and a final in-center session for assessment. They will be provided with equipment such as a cycle ergometer, pulse oximeter, physical activity tracker, and a tablet application (TELEREHAPP) to guide and monitor their home-based exercises. Regular phone contact with healthcare professionals will be maintained for support.
All participants will undergo assessments before and after the program, including a constant work rate endurance test on a cycle ergometer to measure exercise endurance capacity.
What are the possible benefits and risks of participating?
Participants may experience improved physical fitness, which could lead to better dyspnea management and better quality of life. Risks may include muscle soreness, fatigue, or injury related to exercise, independently of group allocation. All exercise sessions will be supervised or monitored to minimize these risks. Participants will receive instructions on how to perform exercises safely and will be encouraged to report any adverse effects promptly.
详细描述
Chronic obstructive pulmonary disease is a disabling respiratory condition and a leading cause of mortality worldwide. Suggested treatments are mainly symptomatic and aim to stabilize the progression of the disease. However, a major consequence of COPD is reduced exercise tolerance, which can lead patients to avoid physical activity, further inducing progressive muscle deconditioning and disabling dyspnea.
Pulmonary rehabilitation is recommended by leading international respiratory societies as a core component of the treatment for people with chronic obstructive pulmonary disease. The effectiveness of pulmonary rehabilitation is well established, with numerous studies showing that it improves dyspnea, exercise capacity, quality of life, as well as it reduces mortality and hospital length of stay following exacerbations.
Paradoxically, as few as 5 to 10% of eligible patients undergo pulmonary rehabilitation. Some known barriers to uptake include transportation difficulties and the limited availability of PR centers.
Telerehabilitation may offer an alternative to traditional center-based programs. Results from studies evaluating the clinical benefits of telerehabilitation suggest that it is non-inferior to traditional center-based pulmonary rehabilitation. However, the clinical outcomes reported for the control groups (center-based programs) in these studies were lower than those reported in the reference meta-analysis by McCarthy et al. (2015), which established the benefits of pulmonary rehabilitation, making interpretation of the results difficult. For these reasons, it remains important to continue investigating and comparing these two different modalities.
This study primarily aims to evaluate the relative effect of a 24-session home-based telerehabilitation program compared to a center-based program in patients with chronic obstructive pulmonary disease. The primary outcome is the change in endurance exercise capacity. Secondary outcomes include changes in maximal exercise capacity, functional capacity, quadriceps maximal isometric strength, functional dyspnea, physical activity, sleep quality, self-efficacy, patient autonomy, quality of life, psychological and health status, and cognitive function. Additional outcomes include adherence, environmental impact, a health economic analysis, and a 1-year follow-up to assess hospitalizations, exacerbations, and mortality as well as others outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician wil be blinded to group allocation.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 80 years
- •Confirmed diagnosis of chronic obstructive pulmonary disease, GOLD stage II to IV
- •Stable condition (no exacerbation in the last month prior to participation)
- •Referred to a pulmonary rehabilitation program
- •With or without oxygen during exercise
- •No pulmonary rehabilitation program in the last 12 months prior to participation
- •Living at home with another adult present during exercise sessions
- •Affiliated with a health insurance system
- •Able to read and understand the information letter and sign the consent form
- •Non-inclusion criteria:
- •Referred to pulmonary rehabilitation before lung cancer surgery
- •Referred to pulmonary rehabilitation before lung volume reduction surgery scheduled within the next four months
- •Visual, cognitive, or auditory impairments incompatible with participation in a tele-pulmonary rehabilitation program
- •Orthopedic, neurological, cardiovascular, or neuromuscular conditions limiting exercise training on a cycle ergometer
- •Active cancer
- •Unable to provide informed consent
- •Under legal guardianship or curatorship
- •Pregnant or breastfeeding women
- •Exclusion Criterion:
- •Withdrawal of consent
排除标准
- 未提供
结局指标
主要结局
Endurance time
时间窗: 2 months
Endurance time will be assessed during a constant work rate endurance test (75% of peak power output) on a cycle ergometer before and after the prehabilitation program and after 1 year of the enrollement date. The pre-specified minimal clinically important difference is set at 105 seconds.
次要结局
- Endurance time(One year)
- Peak oxygen uptake(2 months)
- Peak power output(2 months)
- Functional capacity(One year)
- Quadriceps muscle isometric strength(One year)
- Quality of life - Saint George's Respiratory Questionnaire(One year)
- Quality of life - Euro-Qol five-dimension five-level questionnaire(One year)
- Functional dyspnea(One year)
- Intensity of dyspnea during exercise(One year)
- Intensity of lower limb fatigue during exercise(One year)
- Sensory dimension of dyspnea following exercise(One year)
- Affective dimension of dyspnea following exercise(One year)
- Health status(One year)
- Symptoms of anxiety(One year)
- Symptoms of depression(One year)
- Cognitive function(One year)
- Objective physical activity(One year)
- Sleep quality - Pittsburg sleep quality index(One year)
- Sleep quality - Visual analog scale(One year)
- Auto-efficacy(One year)
- Autonomy support in health care settings(One year)
- Adherence to exercise training(2 months)
- Adherence to self management(2 months)
- Environmental impact(2 months)
- Exacerbations(One year)
- Hospitalization rate(One year)
- Death rate(One year)
- Health economic evaluation - Cost(One year)
- Health economic evaluation - Incremental cost utility ratio(One year)
- Health economic evaluation - Incremental cost effectiveness ratio(One year)