Pilot Study Evaluating the Feasibility and Appropriateness of a Telerehabilitation Exercise Program in People With Post-COVID-19 Sequelae: a Single-center Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The feasibility of study procedures
研究概览
简要总结
The goal of this study pilot randomized controlled study is to evaluate the feasibility of the study procedures and to compare the preliminary efficacy of a rehabilitation program given in a "remote" (telerehabilitation) or "face-to-face" model for adult patients who had confirmed SARS-CoV-2 infection and still have symptoms after eight weeks of infection. The main question it aims to answer is:
- Are the study procedures feasible?
- Will the two groups have similar results for the preliminary efficacy outcomes?
Researchers will compare group telerehabilitation to a face-to-face group to see if it's comparable.
Participants will:
- Take part in a 60-minute training session, 3 times a week in person or remotely
- Visit the clinic before starting the training program and after 8 weeks of training
- Keep a diary of their symptoms, if any
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (≥18 years)
- •confirmed SARS-CoV-2 infection defined by positive polymerase chain reaction (PCR) testing and/or antigen test results
- •referred to the pneumology clinic for a modified British Medical Research Council (mMRC) dyspnea score of 2-3 after a minimum of eight weeks of infection
- •VO₂max of less than 80% of the predicted value
- •receiving a medical prescription for rehabilitation following initial assessment by a pulmonologist
- •being able to walk independently
- •providing informed consent
- •having a good internet connection (i.e., a minimum download speed of 4 Mbps and an upload speed of 4 Mbps)
- •being in possession of a computer or tablet equipped with a camera enabling videoconferencing.
排除标准
- •requiring in-hospital rehabilitation at discharge
- •evidence of medical instability (i.e., moderate or severe cardiac disease, ischemic or severe hemorrhagic stroke, or neurodegenerative disease, unstable fracture)
- •history of severe cognitive or mental impairment
- •already enrolled in another rehabilitation program
结局指标
主要结局
The feasibility of study procedures
时间窗: 8 weeks
This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % of participants who drop out or withdraw from a study (attrition rate), % completed session (adherence rate); number of adverse events and % of participants satisfaction.
次要结局
- Lower-limb endurance(8 weeks)
- Change in Clinical Frailty(8 weeks)
- Exercise capacity(8 weeks)
- Walking capacity(8 weeks)
- Physical performance(8 weeks)
- Change in Independence in activities of daily living(8 weeks)
- Change in Quality of life(8 weeks)
研究者
Marie-Claude Lehoux
Principal Investigator
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec