Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.
In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.
详细描述
Exclusion criteria:
- Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- Patients with significant and unstable cardiovascular disease.
- Inability to understand and/or answer questionnaires.
- Refusal to use a smartphone or digital device.
- Unable to access an internet connection at home.
Analysis:
- The main analysis will be the univariate intention-to-treat analysis of the primary outcome.
- Secondary analyzes will include:
- Analysis with intention to treat secondary endpoints.
- Multivariate analysis of the efficiency criteria.
- Univariate and multivariate medico - economic cost - utility analyzes, with their respective sensitivity analyzes.
Protocol:
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
盲法说明
This study will be an Open study.
For the primary outcome the analysis will be blind to the investigator
入排标准
- 年龄范围
- 40 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COPD according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) creteria.
- •Presence of an incompletely reversible obstructive ventilatory disorder defined by a report VEMS / CVF lower than the lower limit of normal post-bronchodilator.
- •Patient on RR for four weeks in respiratory rehabilitation center.
- •Aged between 40 and 78 years.
排除标准
- •Presence of contraindications for exercise training (neuromuscular disease, orthopedic cause).
- •Patients with significant and unstable cardiovascular disease.
- •Inability to understand and/or answer questionnaires.
- •Refusal to use a smartphone or digital device.
- •Unable to access an internet connection at home.
结局指标
主要结局
Quality of Life of chronic obstructive pulmonary disease patients after a 1-year téléherabilitaion versus standard care program, after an initial short-term pulmonary rehabilitation program
时间窗: 12 months
Quality of life assessed by the Saint Georges Respiratory Questionnaire. Three scores are calculated for the components: Symptoms; Activities; Impacts. A Total SCORE is also calculated. The minimum significant difference is 4 points.
次要结局
- Predictive model of physical activity behavior(At 12 months)
- Physical Activity behaviors.(12 months)
- Post-intentional variables(6 months)
- Pre-intentional variables(baseline)