A Pilot Study to Evaluate the Implantation and the Impact of a Hybrid Telerehabilitation Program Based on Cardiopulmonary Rehabilitation Principles for People With Post-COVID Affection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Fatigue and post-exercise malaise
研究概览
简要总结
Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of patients with COVID-19 report persistent symptoms up to 8 months after the infection. There are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate the acceptability and the potential impact of the program on treating patients with functional limitations and persistent fatigue symptoms. It's a pre and post-study without a control group.
详细描述
Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of patients with COVID-19 report persistent symptoms up to 8 months after the infection. There are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate the acceptability and the potential impact of the program on treating patients with functional limitations and persistent fatigue symptoms. It's a pre and post-study without a control group. The intervention will be based on cardiopulmonary rehabilitation principles and will be administered for 12 weeks. Fatigue, post-exertional malaise, and functional/exercise capacities will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living in the community
- •Living near Sherbrooke (<50km)
- •Having a diagnostic of COVID-19 confirmed (PCR) and post-COVID syndrome (according to the World Health Organization criteria)
- •Being aged between 25 and 65 years old
- •Having access to internet at home
- •Living with a family member/caregiver or having a telephone or a medical alert system (in case of emergency)
- •Reporting persistent fatigue symptoms according to the Fatigue Severity Scale (FSS) (score≥4/7)
- •Reporting functional limitations according to the Post-COVID-19 Functional Status scale (PCFS (score ≥2/4);
- •Being able to give free and informed consent (adequate understanding of the study protocol);
- •Agreeing to perform a pulmonary function test, an exercise stress test, and an ergospirometric exercise test (adequate understanding of steps and procedures);
- •Having a low exercise capacity and moderate-to-severe cardiovascular risk <7 metabolic equivalent of a task (MET) or ≤9 if significant reduction of self-reported exercise tolerance according to the stress test performed on a treadmill - Cornell protocol);
- •Having no other potential explanatory causes for fatigue or reduced exercise capacity according to medical evaluation
排除标准
- •Cognitive impairment: Mini-Mental State Examination (MMSE) ≤24/30
- •Inability to perform or understand study procedures
- •Medical contraindication
结局指标
主要结局
Fatigue and post-exercise malaise
时间窗: 12 weeks
This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.
Acceptability
时间窗: 12 weeks
The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.
The feasibility of the program
时间窗: 12 weeks
This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % who completed the intervention (retention rate) and % completed session/anticipated session (adherence). The security of the program will be evaluated by the number of falls or near fall. Technical difficulty
次要结局
- Heart rate variability (resting)(12 weeks)
- Functional capacity(12 weeks)
- Exercise capacity(12 weeks)
- Lower-limb endurance (estimated)(12 weeks)