Clinical trial NCT04649086: Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection
Official title: Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection: Research Protocol for Randomized Controlled Trial (CovExc)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
Sarcopenia
Muscle Weakness
Keywords: Covid19
Sarcopenia
Muscle Weakness
Eccentric exercises
Rehabilitation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: GIRCI Auvergne Rhône-Alpes
name: Ministry of Health, France
First posted: 2020-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All included participants will be randomly assigned (1:1) using the REDCap software, , at the experimental group or the control group.

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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional walking capacity
timeFrame: Day 0, Month 1, Month 2 and Month 6
Secondary outcomes:
measure: Evaluating of lower extremity functioning by Short Physical Performance Battery (SPPB) score
timeFrame: Day 0, Month 2 and Month 6
measure: Evaluating the maximum muscle strength of the quadriceps by Quadriceps Isometric Maximum Strength (QIMS) test
timeFrame: Day 0, Month 2
measure: Evaluating the fatigability of the quadriceps by Quadriceps Intermittent Fatigue (QIF) test
timeFrame: Day 0, Month 2
measure: Evaluating the global fatigability by Modified Fatigue Impact Scale (MFIS)
timeFrame: Day 0, Month 2 and Month 6
measure: Evaluating functional capacities with EuroQol - 5 Dimensions (EQ-5D) questionnaire
timeFrame: Day 0, Month 2 and Month 6
measure: Evaluating the handgrip strength by standard handgrip strength test
timeFrame: Day 0, Month 2
measure: Metabolomic Profile
timeFrame: Day 0, Month 2 (post-training)
measure: Cross sectional area measurement
timeFrame: Day 0, Month 2 (post-training)
measure: Capillary to fibre ratio.
timeFrame: Day 0, Month 2 (post-training)
measure: Satellite cell number
timeFrame: Day 0, Month 2 (post-training)
measure: Neuromuscular activation
timeFrame: Day 0, Month 2 (post-training)
measure: Quadriceps muscular Oxygen Tissue Saturation
timeFrame: Day 0, Month 2 (post-training)
measure: O2 uptake Efficiency during walk test
timeFrame: Day 0, Month 2 (post-training)
measure: Creatine Kinase (CPK)
timeFrame: Day 0
measure: Creatine Kinase (CPK)
timeFrame: Day 7 (post-training)
measure: Creatine Kinase (CPK)
timeFrame: Month 2 (post-training)
measure: C-reactive protein (CRP)
timeFrame: Day 0
measure: C-reactive protein (CRP)
timeFrame: Day 7 (post-training)
measure: C-reactive protein (CRP)
timeFrame: Month 2 (post-training)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Maxime GROLIER, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Clermont-Ferrand
name: Emmanuel COUDEYRE, MD, PhD
role: STUDY_DIRECTOR
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