Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease: Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of lost to follow up patients
研究概览
简要总结
Systematic sclerosis (SSc) is a potentially severe disease characterized by various visceral involvements including lung. The investigators hypothesize that a respiratory rehabilitation program specifically designed for people with systematic sclerosis with early lung disease could help to decrease respiratory deficiencies, improve aerobic capacity and prevent activity limitations and participation restrictions.
Before testing the effectiveness of such a program, a pilot study is needed to assess its feasibility and optimize its content.
Participants will have 1 supervised session in the outpatient rehabilitation department. Each patient will then perform the home personalized exercises program for 3 months.
The feasibility of the program will be assessed at 3 months using patients' adherence to the program (assessed by the number of lost to follow-up, the number of questionnaires not completed, the amount of aerobic activity and the amount of home personalized exercises, treatment burden, adverse effects and quality of life.
详细描述
SSc is responsible for a reduced life expectancy. The prognosis depends on the presence of severe visceral damage and more particularly on the presence of interstitial lung damage, pulmonary arterial hypertension or specific cardiac damage which represent the 3 main causes of mortality in SSc.
The importance of rehabilitation in SSc has been confirmed by the latest INSERM Collective Expertise 2019). The objectives of functional rehabilitation in SSc are to prevent and/or reduce the specific (cutaneous, oral, cardiorespiratory, musculoskeletal) and non-specific (exercise deconditioning, fatigue, anxiety and depression) impairments frequently characterizing the evolution of the disease. Based on the latest practice recommendations for the diagnosis and treatment of idiopathic pulmonary fibrosis, people with a confirmed diagnosis of idiopathic pulmonary fibrosis and significant exercise and activity limitations should follow a respiratory rehabilitation program.
The value of a specific respiratory rehabilitation program for people with SSc is then a matter of interest. A pilot study is needed to assess the feasibility and optimize the content of a rehabilitation program. The investigators aimed to study the feasibility of a personalized home-based respiratory rehabilitation program in people with SSc with early lung disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemic sclerosis according to ACR/EULAR 2013 criteria
- •Lung involvement, with FCV > 70% on PFT
排除标准
- •Inability to understand French
- •Pregnancy or breastfeeding
- •Arterial pulmonary hypertension > 35 mmHg and unexplained dyspnoea or arterial pulmonary hypertension > 40 mmHg
- •Major musculoskeletal impairment incompatible with physical activity
- •other pulmonary disease decreasing FCV
- •Pathological EKG
- •Oxygen saturation at rest or during physical activity < 90%
- •FCV < 70%
研究组 & 干预措施
Home based exercises
1 supervised session in the outpatient rehabilitation department with respiratory, aerobic and muscles strengthening exercises, followed by 3 months of self-manage personalized home exercises program. Cardiac frequency and adherence to exercise will be monitored using an activity tracker (Garmin© watch).
干预措施: Rehabilitation (Other)
结局指标
主要结局
Number of lost to follow up patients
时间窗: 3 months
Adherence to treatment
Self-reported adherence
时间窗: 3 months
Adherence to treatment
Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)
时间窗: 3 months
Adherence to treatment / Burden of program
Check-list to report side effects
时间窗: 3 months
Adherence to treatment
Amount of aerobic work recorded using a connected watch
时间窗: 3 months
Adherence to treatment / Amount of aerobic work recorded using a connected watch with heart rate monitor
Amount of exercises self-reported in a logbook
时间窗: 3 months
Adherence to treatment
Number of uncompleted questionnaires
时间窗: 3 months
Adherence to treatment
Exercise Adherence Rating Scale (EARS) questionnaire
时间窗: 3 months
Adherence to treatment / Amount of exercises
次要结局
- Diffusing capacity(3 months)
- Health Assessment Questionnaire (HAQ)(3 months)
- 12-Items short form survey questionnaire (SF-12)(3 months)
- Maximal oxygen consumption during a 6 minute walking test(3 months)
- Saint Georges hospital questionnaire(3 months)
- Lung volume(3 months)