Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection (CovExc)

University Hospital, Clermont-Ferrand

Status: Terminated

Conditions: Muscle Weakness; Covid19; Sarcopenia

Treatments: Other: Rehabilitation by Eccentric exercises; Other: Rehabilitation by Concentric exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT04649086

2020-A01201-38 (Other Identifier)

PHRCI 2020 COSTE (CovExc)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Eccentric group

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation by Eccentric exercises

Concentric group

Active Comparator group

Description:

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.

Treatment:

Other: Rehabilitation by Concentric exercises