Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection: Research Protocol for Randomized Controlled Trial (CovExc)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Functional walking capacity
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Functional walking capacity
Time Frame: 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.
Secondary Outcomes
- 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))
- Capillary to fibre ratio.(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 the global fatigability by Modified Fatigue Impact Scale (MFIS)(Day 0, Month 2 and Month 6)
- 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))