NCT04649086

Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection

Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection: Research Protocol for Randomized Controlled Trial (CovExc)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19
• Sarcopenia
• Muscle Weakness

Interventions

Type	Name	Description
OTHER	Rehabilitation by Eccentric exercises	Participants will perform 24 exercises sessions (30 minutes) with cycloergometer in eccentric mode (while resisting against self-paced pedaling), inducing a greater muscular hypertrophy as compared with concentric mode, the mechanical stimulation being 3 to 4 times greater at the same level metabolic stimulation.
OTHER	Rehabilitation by Concentric exercises	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.

Timeline

• Start date: 2020-06-05
• Primary completion: 2022-01-07
• Completion: 2022-01-07
• First posted: 2020-12-02
• Last updated: 2024-02-15

Locations

3 sites across 1 country: France