Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection

NCT04649086 | Terminated

• 2 other identifiers: PHRCI 2020 COSTE (CovExc)2020-A01201-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19; Sarcopenia; Muscle Weakness

Keywords

Covid19; Sarcopenia; Muscle Weakness; Eccentric exercises; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Functional walking capacity

  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.

  Day 0, Month 1, Month 2 and Month 6

Secondary Outcomes (19)

• Evaluating of lower extremity functioning by Short Physical Performance Battery (SPPB) score

  Day 0, Month 2 and Month 6

• Evaluating the maximum muscle strength of the quadriceps by Quadriceps Isometric Maximum Strength (QIMS) test

  Day 0, Month 2

• Evaluating the fatigability of the quadriceps by Quadriceps Intermittent Fatigue (QIF) test

  Day 0, Month 2

• 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

Study Arms (2)

Eccentric group

EXPERIMENTAL

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.

Other: Rehabilitation by Eccentric exercises

Concentric group

ACTIVE COMPARATOR

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.

Other: Rehabilitation by Concentric exercises

Interventions

Rehabilitation by Eccentric exercises OTHER

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.

Eccentric group

Rehabilitation by Concentric exercises OTHER

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.

Concentric group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• GIRCI Auvergne Rhône-Alpes: collaborator
• Ministry of Health, France: collaborator

Study Sites (3)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Dijon

Dijon, 21000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Related Publications (7)

• Zhang P, Li J, Liu H, Han N, Ju J, Kou Y, Chen L, Jiang M, Pan F, Zheng Y, Gao Z, Jiang B. Long-term bone and lung consequences associated with hospital-acquired severe acute respiratory syndrome: a 15-year follow-up from a prospective cohort study. Bone Res. 2020 Feb 14;8:8. doi: 10.1038/s41413-020-0084-5. eCollection 2020.

  PMID: 32128276 BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Connolly B, Salisbury L, O'Neill B, Geneen L, Douiri A, Grocott MP, Hart N, Walsh TS, Blackwood B. Exercise rehabilitation following intensive care unit discharge for recovery from critical illness: executive summary of a Cochrane Collaboration systematic review. J Cachexia Sarcopenia Muscle. 2016 Dec;7(5):520-526. doi: 10.1002/jcsm.12146. Epub 2016 Sep 16.

  PMID: 27891297 BACKGROUND

• van Zanten ARH, De Waele E, Wischmeyer PE. Nutrition therapy and critical illness: practical guidance for the ICU, post-ICU, and long-term convalescence phases. Crit Care. 2019 Nov 21;23(1):368. doi: 10.1186/s13054-019-2657-5.

  PMID: 31752979 BACKGROUND

• Wu Y, Xu X, Chen Z, Duan J, Hashimoto K, Yang L, Liu C, Yang C. Nervous system involvement after infection with COVID-19 and other coronaviruses. Brain Behav Immun. 2020 Jul;87:18-22. doi: 10.1016/j.bbi.2020.03.031. Epub 2020 Mar 30.

  PMID: 32240762 BACKGROUND

• Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.

  PMID: 17133183 BACKGROUND

• Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685.

  PMID: 18840842 BACKGROUND

MeSH Terms

Conditions

COVID-19; Sarcopenia; Muscle Weakness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Study Officials

• Maxime GROLIER, MD, MSc

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• Emmanuel COUDEYRE, MD, PhD

  CHU de Clermont-Ferrand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: December 2, 2020
• Study Start: June 5, 2020
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: February 15, 2024

Record last verified: 2021-05

Locations

FR (3)