Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection: Research Protocol for Randomized Controlled Trial (CovExc)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Functional walking capacity
研究概览
简要总结
With the COVID-19 pandemic, the number of patients to be treated in rehabilitation increased .
Hospitalization for severe infection can induce muscular atrophy and muscular dysfunction that persists for several months and rehabilitation capacities may be exceeded.
Exercises in eccentric mode could be performed, inducing greater muscular hypertrophy, muscle strength, power and speed than concentric exercises.
The goal of this study was to compare functional recovery at 2 months after a training program in eccentric and concentric mode after severe COVID-19.
An effective rehabilitation could help reduce costs and duration of care.
详细描述
This is a prospective, open, controlled randomized study (2 x 60 individuals) performed in 3 centers. Participants will perform 24 exercise sessions on cycloergometer (3 sessions/week, 8 weeks). The experimental group (eccentric) will perform 5 habituation sessions: the initial power of the exercise will be set to 10 Watts and then increased by 10% each session, depending on the muscle tolerance. The training power must correspond to 3 times that of the control group to obtain a similar metabolic stimulation. The control group (concentric) will perform exercise training at an intensity of 60% of the reserve heart rate determined during an initial cardiorespiratory test. The primary outcome will be the change in distance covered during the 6-min walk test between the initial assessment and month 2. Secondary outcomes will include study of sarcopenia, muscle strength, general and muscular fatigue, quality of life, blood metabolomic data, ex vitro data for mitochondrial and histo-biochemical functionality from muscle biopsies of the Vastus Lateralis.
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
Evaluations will be carried out with blinding by investigators different from those involved in the exercise training sessions. Patients will be blinded to the training mode hypothesis.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 80 years old
- •Diagnosed for SARS-CoV-2 infection (COVID-19) requiring a rehabilitation program at least 1 month after the hospitalization
- •Autonomy in daily life activities 1 month after diagnosis
- •Able to walk for 6 min (discontinuous walking possible)
- •Giving informed written consent to participate in the study
- •Health insurance coverage
排除标准
- •Cardiovascular or respiratory contraindication to the rehabilitation program
- •Difficulty to perform an eccentric exercise on a seated ergometer
- •Pregnant or breastfeeding
- •Under guardianship, curatorship or deprived of liberty
- •Taking antivitamin K anticoagulation (muscle biopsy)
- •Refusal to participate
研究组 & 干预措施
Eccentric group
The experimental group (eccentric) will perform 5 habituation sessions: the initial power of the exercise will be set to 10 Watts and then increased by 10% each session, depending on the muscle tolerance. The training power must correspond to 3 times that of the control group to obtain a similar metabolic stimulation and will be adapted according to the pain felt at the end of the session.
干预措施: Rehabilitation by Eccentric exercises (Other)
Concentric group
The control group (concentric) will perform exercise training at an intensity of 60% of the reserve heart rate determined during an initial cardiorespiratory test. The power will be adjusted weekly to stay within the target heart rate range.
干预措施: Rehabilitation by Concentric exercises (Other)
结局指标
主要结局
Functional walking capacity
时间窗: Day 0, Month 1, Month 2 and Month 6
Average change from baseline walking capacity measured by the 6-minutes walk test (6MWT), expressed in meters. All patients will be asked to cover the longest distance over a 30-meters distance in 6 min with or without stopping and with standardized verbal encouragements according to standard recommendations; to take into account a learning effect, the test will be performed twice, with the longer distance retained, expressed in meters. To prevent adverse effect, pulsed oxygen saturation (% of pSO²) and heart rate (heartbeat per minute) will be monitored continuously throughout the test by using a digital oximeter.
次要结局
- Capillary to fibre ratio.(Day 0, Month 2 (post-training))
- Evaluating the global fatigability by Modified Fatigue Impact Scale (MFIS)(Day 0, Month 2 and Month 6)
- Evaluating of lower extremity functioning by Short Physical Performance Battery (SPPB) score(Day 0, Month 2 and Month 6)
- Evaluating the fatigability of the quadriceps by Quadriceps Intermittent Fatigue (QIF) test(Day 0, Month 2)
- O2 uptake Efficiency during walk test(Day 0, Month 2 (post-training))
- Metabolomic Profile(Day 0, Month 2 (post-training))
- Cross sectional area measurement(Day 0, Month 2 (post-training))
- Evaluating the maximum muscle strength of the quadriceps by Quadriceps Isometric Maximum Strength (QIMS) test(Day 0, Month 2)
- Satellite cell number(Day 0, Month 2 (post-training))
- Neuromuscular activation(Day 0, Month 2 (post-training))
- Quadriceps muscular Oxygen Tissue Saturation(Day 0, Month 2 (post-training))
- Creatine Kinase (CPK)(Month 2 (post-training))
- Evaluating functional capacities with EuroQol - 5 Dimensions (EQ-5D) questionnaire(Day 0, Month 2 and Month 6)
- Evaluating the handgrip strength by standard handgrip strength test(Day 0, Month 2)
- C-reactive protein (CRP)(Month 2 (post-training))
- C-reactive protein (CRP)(Day 0)
- Creatine Kinase (CPK)(Day 0)
- Creatine Kinase (CPK)(Day 7 (post-training))
- C-reactive protein (CRP)(Day 7 (post-training))