Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients

NCT06271122 | Completed

• 1 other identifier: COMPET-1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease associated with various comorbidities, including muscle weakness (MW), which is very worrying due to its negative impact on patients' quality of life and survival. To address this issue, muscle strengthening is incorporated into pulmonary rehabilitation programs. However, its effectiveness is unclear, as although there is an average improvement in muscle strength, one in two patients does not show a clinically relevant improvement. To understand this non-response, it is crucial to examine the effect of muscle strengthening programs on the two main determinants of force production: the muscle and the central command. Muscle adaptations following a muscle strengthening program are well-documented, showing improvements in muscle function (cross-sectional area, lean mass, etc.). Conversely, only one study has investigated central adaptations after a muscle strengthening program, clearly demonstrating a lack of effect. The investigators hypothesize that patients showing no improvement in muscle strength after pulmonary rehabilitation (non-responders) have a significantly lower level of voluntary activation before starting the program compared to responding patients (responders).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Muscle weakness; Voluntary activation; Pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• Central voluntary activation assessed by transcranial magnetic stimulation (TMS)

  Difference in central voluntary activation (NAVcentral), representative of central command, between responders and non-responders at the beginning of a pulmonary rehabilitation program.

  Before and after pulmonary rehabilitation (Day 1 and day 28)

Secondary Outcomes (5)

• Muscle excitability assessed by femoral magnetic stimulation (FMS)

  Before and after pulmonary rehabilitation (Day 1 and day 28)

• Contractile properties assessed by femoral magnetic stimulation (FMS)

  Before and after pulmonary rehabilitation (Day 1 and day 28)

• Corticospinal excitability assessed by transcranial magnetic stimulation (TMS)

  Before and after pulmonary rehabilitation (Day 1 and day 28)

• Intra-cortical inhibitions transcranial magnetic stimulation (TMS)

  Before and after pulmonary rehabilitation (Day 1 and day 28)

• Voluntary activation assessed by femoral magnetic stimulation (FMS)

  Before and after pulmonary rehabilitation (Day 1 and day 28)

Study Arms (1)

Voluntary activation assessed by magnetic stimulation group

EXPERIMENTAL

The inclusion visit (V0) will be conducted at the beginning of the stay. On Day 1 (D+1), the patients will undergo the first visit (V1), during which specific evaluations (maximal quadriceps force test, transcranial and femoral magnetic stimulation) will be performed. Subsequently, the patients will follow the standard 4-week PR program. On Day 28 (D+28), patients will undergo the second visit (V2), during which they will undergo the same evaluations as those performed in V1.

Other: Voluntary activation assessed by magnetic stimulation

Interventions

Voluntary activation assessed by magnetic stimulation OTHER

Visits V1 (Day 1) and V2 (Day 28) are identical. The dominant leg will be tested, the patient positioned on the ergometer and EMG electrodes placed on the quadriceps. The familiarization for femoral magnetic stimulation (FMS) will begin, the stimulation site identified and the supramaximality verified. After a warm up, the subject will perform 3 maximal voluntary isometric contractions (MVIC; 5s, rest = 30s), 3 MVIC reaching maximal force as quickly as possible, and 4 MVIC during which magnetic stimulation (intensity = 100%) will be applied during the contraction and 2 seconds after the contraction ends. For transcranial magnetic stimulation, the stimulation area and intensity will be determined. After that, the patient will perform 3 CMIV at 100%, 75%, 50% and 35% of CMIV. During each contraction, magnetic stimulation will be delivered during the force plateau.

Voluntary activation assessed by magnetic stimulation group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 40 to 80 years
• Patients admitted to a 4-week inpatient pulmonary rehabilitation program
• Patients diagnosed with COPD (Stage I to IV) according to internationally recognized criteria determined by the GOLD
• Patients able to understanding, speaking, reading, and writing French
• Patients for whom informed consent will be obtained after a maximum 24-hour reflection period
• Patients affiliated with a French social security system or beneficiaries of such a system

You may not qualify if:

• Diagnosis of neurological and/or cerebrovascular disease corresponding to code 8 of the International Classification of Diseases (ICD-11)
• Possession of any invasive metallic medical devices (pacemaker, prosthesis, etc.) except for dental prostheses (crowns and bridges).
• Epileptic risk factors (chronic alcoholism, brain surgery, recent head trauma)
• Orthopedic conditions that may affect the completion of protocol tests and assessments
• Recent exacerbation (within 4 weeks)
• Adults protected by law or patients under guardianship or conservatorship
• Individuals deprived of liberty by a judicial or administrative decision
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Korian: lead

Study Sites (1)

Clinique du Souffle La Vallonie

Lodève, 34700, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Muscle Weakness

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Nelly Heraud

  Director of research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 21, 2024
• Study Start: January 18, 2024
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)