Clinical trial NCT06271122: Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients
Official title: Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Muscle weakness
Voluntary activation
Pulmonary rehabilitation
Lead sponsor: Korian
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease. Beyond respiratory symptoms, COPD is linked to comorbidities like muscle weakness (MW), significantly worrying due to its impact on patients' quality of life and survival. MW affects 32% to 57% of patients, predominantly in the lower limbs, contributing to exercise intolerance, reduced quality of life, and increased healthcare costs.

To address MW, muscle strengthening is incorporated into pulmonary rehabilitation (PR) programs. Despite significant average improvements in quadriceps muscle strength reported in the literature, a recent study highlight that 50% of patients did not clinically enhance their strength and were called non-responders (NR).

To understand this non-response, it's crucial to investigate the impact of muscle strengthening programs on the determinants of strength loss. While muscle atrophy was initially considered a major factor, studies have shown that muscle mass does not entirely explain the loss of strength. Impairment of motor control has emerged as a significant secondary determinant of muscle strength loss.

Peripheral muscle adaptations, including increased muscle surface and lean thigh mass, are well-documented. However, regarding motor control adaptations, a single study using a reference method on the quadriceps indicates a lack of effect of PR programs on central control. This observation suggests that non-responders in terms of strength may exhibit impaired motor control from the onset of the PR program.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Patients in a period of relative exclusion compared to another protocol
* Adults protected by law or patients under guardianship or conservatorship
* Individuals deprived of liberty by a judicial or administrative decision
* Pregnant or breastfeeding women

Primary outcomes:
measure: Central voluntary activation assessed by transcranial magnetic stimulation (TMS)
timeFrame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Secondary outcomes:
measure: Muscle excitability assessed by femoral magnetic stimulation (FMS)
timeFrame: Before and after pulmonary rehabilitation (Day 1 and day 28)
measure: Contractile properties assessed by femoral magnetic stimulation (FMS)
timeFrame: Before and after pulmonary rehabilitation (Day 1 and day 28)
measure: Corticospinal excitability assessed by transcranial magnetic stimulation (TMS)
timeFrame: Before and after pulmonary rehabilitation (Day 1 and day 28)
measure: Intra-cortical inhibitions transcranial magnetic stimulation (TMS)
timeFrame: Before and after pulmonary rehabilitation (Day 1 and day 28)
measure: Voluntary activation assessed by femoral magnetic stimulation (FMS)
timeFrame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Other outcomes:
Locations:
city: Lodève
country: France
facility: Clinique du Souffle La Vallonie
Study officials:
affiliation: Director of research
name: Nelly Heraud
role: STUDY_DIRECTOR
References: