Investigator-blinded Randomized Controlled Trial Examining the Safety and Feasibility of Different Exercise Training Programs in Patients Who Have Survived COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse effects
研究概览
简要总结
This current protocol encompasses an investigator-blinded randomized exercise intervention in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.
The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.
详细描述
The study is a randomized crossover trial testing the feasibility and safety of three different training protocols in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.
The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.
The study consists of 4 visits with 1 baseline session (a medical screening and fitness test) and 3 different training sessions. Each training is separated by 1-week washout, to account for potential confounding by leisure activity performed just before the training, patients will be wearing activity watches (Polar).
Feasibility and safety evaluation will be based on 1) how tolerable and enjoyable the training was based on a subjective questionnaire (Likert Scale) 2) compliance to the prescribed exercise protocol with regard to duration and intensity and 3) experienced side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are randomly allocated following successful completion of the baseline measurements. A researcher, that is not involved in testing or training procedures, generates a computer-generated block randomization schedule with balanced permutations. To ascertain allocation concealment, the block sizes will not be disclosed. The schedule is forwarded to a research assistant, who is not involved in any study procedures and stored on a password protected computer. Following the baseline measurements, the participants are given consecutive numbers. These are forwarded to the research assistant, who returns the corresponding allocation sequence to the study coordinator. The participants are blinded for treatment allocation until treatment assignment. However, following the initial two treatments blinding of the participants is no longer possible. All study personal involved with data collection will be blinded during baseline testing.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 40 years
- •A laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 6 months after hospital discharge
- •≤10 L oxygen requirement during hospitalization
排除标准
- •Present atrial fibrillation
- •Diagnosed with acute myocarditis
- •Health conditions that prevent participating in the exercise intervention
- •Patients who cannot undergo MR scans (e.g. kidney disease or metallic implants)
- •Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
结局指标
主要结局
Adverse effects
时间窗: Through study completion, an average of 3 months
Adverse effect which leads to termination of the exercise training, registered as a binary outcome (yes/no)
10-point Likert scale
时间窗: Through study completion, an average of 3 months
the 10-point Likert scale, which evaluates enjoyment and perceived tolerance of each training protocol at the end of each training session using a 10-point Likert scale, which is one of the most fundamental and frequently used psychometric tools in social science research. Patients have to indicate the degree to which they agreed with the following statement before training: "How motivated are you for today's training?" following two statements after the training: "How enjoyable have today´s training session been?" and "How tolerant has today´s training been?" A higher number describes better agreement.
Participant adherence to the training dose
时间窗: Through study completion, an average of 3 months
Percentage completed exercise of the total duration
Participant adherence to the training intensity
时间窗: Through study completion, an average of 3 months
Percentage of the exercise session spent at a heart rate above 85% of maximal heart rate
次要结局
- Rate of perceived exertion(The secondary outcome measure will be evaluated through study completion, an average of 3 months)
- Post COVID-19 Functional scale(The secondary outcome measure will be evaluated through study completion, an average of 3 months)
研究者
Regitse Christensen
Principal investigator
Rigshospitalet, Denmark