Chronic Obstructive Pulmonary DiseaseNCT06271122
Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients
A study testing Voluntary activation assessed by magnetic stimulation in people with Chronic Obstructive Pulmonary Disease, run by Korian at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Voluntary activation assessed by magnetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2024to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Adults protected by law or patients under guardianship or conservatorship
- Individuals deprived of liberty by a judicial or administrative decision
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Voluntary activation assessed by magnetic stimulation
- Keywords
- COPD, Muscle weakness, Voluntary activation, Pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary activation assessed by magnetic stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Voluntary activation assessed by magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after pulmonary rehabilitation (Day 1 and day 28)
Secondary outcomes (5)
Muscle excitability assessed by femoral magnetic stimulation (FMS)
Change in M waves's variables between responders and non-responders at the beginning and the end of the pulmonary rehabilitation program.
Measured: Before and after pulmonary rehabilitation (Day 1 and day 28)
Contractile properties assessed by femoral magnetic stimulation (FMS)
Change in twitch's variables between responders and non-responders at the beginning and the end of the pulmonary rehabilitation program.
Measured: Before and after pulmonary rehabilitation (Day 1 and day 28)
Corticospinal excitability assessed by transcranial magnetic stimulation (TMS)
Change in MEP's variables between responders and non-responders at the beginning and the end of the pulmonary rehabilitation program.
Measured: Before and after pulmonary rehabilitation (Day 1 and day 28)
Intra-cortical inhibitions transcranial magnetic stimulation (TMS)
Change in MEP's silent period, representative of intra-cortical inhibitions, between responders and non-responders at the beginning and the end of the pulmonary rehabilitation program.
Measured: Before and after pulmonary rehabilitation (Day 1 and day 28)
Voluntary activation assessed by femoral magnetic stimulation (FMS)
Change in voluntary activation (central and peripheral) between responders and non-responders at the beginning and the end of the pulmonary rehabilitation program.
Measured: Before and after pulmonary rehabilitation (Day 1 and day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start18 Jan 2024
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly Heraud, Study director, Director of research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271122
- Sponsor's protocol ID
- COMPET-1
- Status last verified
- Jul 2024
- First submitted
- 19 Jan 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients
- ClinicalTrials.gov ID
- NCT06271122
- Acronym / sponsor ID
- COMPET-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Muscle weakness, Voluntary activation, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- KorianUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voluntary activation assessed by magnetic stimulation group | Experimental | Other: Voluntary activation assessed by magnetic stimulationThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voluntary activation assessed by magnetic stimulationVisits 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. | Other | Voluntary activation assessed by magnetic stimulation group |
Primary outcome
Central voluntary activation assessed by transcranial magnetic stimulation (TMS)
Time frame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Difference in central voluntary activation (NAVcentral), representative of central command, between responders and non-responders at the beginning of a pulmonary rehabilitation program.
5 secondary outcomes
Muscle excitability assessed by femoral magnetic stimulation (FMS)
Time frame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Contractile properties assessed by femoral magnetic stimulation (FMS)
Time frame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Corticospinal excitability assessed by transcranial magnetic stimulation (TMS)
Time frame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Intra-cortical inhibitions transcranial magnetic stimulation (TMS)
Time frame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Voluntary activation assessed by femoral magnetic stimulation (FMS)
Time frame: Before and after pulmonary rehabilitation (Day 1 and day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly Heraud study director
Director of research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voluntary activation assessed by magnetic stimulation in people with Chronic Obstructive Pulmonary Disease, run by Korian at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central voluntary activation assessed by transcranial magnetic stimulation (TMS) (time frame: Before and after pulmonary rehabilitation (Day 1 and day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.