NCT06271122Completed
Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients
Source: ClinicalTrials.gov · Last updated 29 Jul 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 19 Jan 2024
- Start date
- 18 Jan 2024
- Primary completion date
- 26 Jul 2024
- Lead sponsor
- Korian
- Diseases
- COPD
- NCT number
- NCT06271122
What you commit to
- Study type: Interventional
- Participants enrolled: 41
- From 18 Jan 2024 to the primary completion date, 26 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Epileptic risk factors (chronic alcoholism, brain surgery, recent head trauma)
Other illness
- Diagnosis of neurological and/or cerebrovascular disease corresponding to code 8 of the International Classification of Diseases (ICD-11)
- Orthopedic conditions that may affect the completion of protocol tests and assessments
Other
- Possession of any invasive metallic medical devices (pacemaker, prosthesis, etc.) except for dental prostheses (crowns and bridges).
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique du Souffle la Vallonie Coordinator of this site? Confirm its status | Lodève | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.