Fatigue is a prevalent symptom in Chronic Obstructive Pulmonary Disease (COPD) that limits patients in their daily living activities. It is now well established that COPD patients may have altered neuromuscular functions compared to healthy individuals. However, the different studies conducted on muscle fatigue in COPD have been done independently of any cognitive solicitation, yet present in most of daily living activities. Therefore, the aim of this research is to evaluate the impact of the disease on neuromuscular fatigue during dual-task situation (simultaneous accomplishment of a muscle contraction and a cognitive task). A better understanding of fatigue in COPD will promote the development of new perspectives in patient management.
The hypothesis is that COPD patients will exhibit increased fatigue level (compared to healthy subjects), particularly during dual-task situation. It is assumed that the higher negative effect associated with the dual-task will be related to different neurophysiological mechanisms (i.e., neuromuscular fatigue, autonomic nervous system activity, mental fatigue).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Other: Single then dual task situation Other: Dual then single task situation | Not Applicable |
This study will include three experimental sessions for both COPD patients and healthy participants. These experimental sessions will be performed on three separate days. Each session will last between 1.5 and 2 hours.
The first session will correspond to a familiarization session with the different tests that will be performed during the two next sessions. During this first session, different functional tests will be also performed : 1-minute sit-to-stand tests and postural tests, with and without a concomitant cognitive task.
The second and third sessions will correspond to experimental sessions during which the participants will accomplish a fatiguing task in single or dual-task situation (randomized order). The cognitive task will be a memory cognitive task, called n-back task. The fatiguing tasks will involve submaximal isometric contractions of the knee extensors performed until task failure. The neuromuscular fatigue will be evaluated regularly during the fatiguing tasks (i.e. about each minute) using the magnetic stimulation of the femoral nerve in order to assess to central and peripheral determinants of the neuromuscular fatigue. Moreover, the autonomic nervous system activity (via cardiac recordings), perceived exertion and cognitive performance (in dual-task situation) will be continuously recorded during the fatiguing tasks. Before and after each fatiguing tasks, several questionnaires will be completed (i.e. mood, motivation, subjective workload) in order to evaluate the psychological determinants of performance.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD) |
| Actual Study Start Date : | September 16, 2020 |
| Estimated Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | September 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Evaluation of fatigue level in BPCO patients (condition 1) |
Other: Single then dual task situation
Firstly, the participants have to perform the fatiguing task in simple task condition (control condition, i.e., muscle contraction alone). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same fatiguing task with a concomitant memory cognitive task (i.e. dual-task condition).
|
| Experimental: Evaluation of fatigue level in BPCO patients (condition 2) |
Other: Dual then single task situation
Firstly, the participants have to perform the fatiguing task in dual-task condition (i.e. muscle fatiguing contraction with a concomitant memory cognitive task). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same muscle fatiguing task without a concomitant memory cognitive task (i.e. control condition).
|
| Active Comparator: Evaluation of fatigue in control patients (condition 1) |
Other: Single then dual task situation
Firstly, the participants have to perform the fatiguing task in simple task condition (control condition, i.e., muscle contraction alone). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same fatiguing task with a concomitant memory cognitive task (i.e. dual-task condition).
|
| Active Comparator: Evaluation of fatigue in control patients (condition 2) |
Other: Dual then single task situation
Firstly, the participants have to perform the fatiguing task in dual-task condition (i.e. muscle fatiguing contraction with a concomitant memory cognitive task). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same muscle fatiguing task without a concomitant memory cognitive task (i.e. control condition).
|
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
COPD patients :
Healthy volunteers :
Exclusion Criteria:
COPD patients :
Healthy volunteers:
| Contact: Anaïs MAUGARD | 04 94 14 55 29 ext +33 | Anais.maugardlandre@ch-toulon.fr |
| France | |
| Université de Toulon, laboratoires LAMHESS et IAPS | Not yet recruiting |
| La Garde, Var, France, 83130 | |
| Contact: Jean-Marc VALLIER 04 94 14 27 57 ext +33 jean-marc.vallier@univ-tln.fr | |
| Hôpital d'Instruction des Armées Sainte-Anne | Recruiting |
| Toulon, Var, France, 83000 | |
| Contact: Nicolas PALEIRON, MD 04 83 16 24 23 ext +33 nicolas.paleiron@intradef.gouv.fr | |
| Study Director: | Jean-Marc VALLIER, MD PhD | Université de Toulon |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 19, 2019 | ||||
| First Posted Date ICMJE | July 23, 2019 | ||||
| Last Update Posted Date | November 17, 2020 | ||||
| Actual Study Start Date ICMJE | September 16, 2020 | ||||
| Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Endurance time differences between simple and dual-task conditions, in COPD patients compared to healthy participants [ Time Frame: 7 days ] The endurance times will correspond to the duration of the fatiguing tasks (simple and dual-task). The endurance time differences between simple and dual-task conditions will be calculated as follows : Endurance time in simple task condition - Endurance time in dual-task condition = Difference of endurance time.
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neuromuscular Fatigue in COPD | ||||
| Official Title ICMJE | Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Brief Summary |
Fatigue is a prevalent symptom in Chronic Obstructive Pulmonary Disease (COPD) that limits patients in their daily living activities. It is now well established that COPD patients may have altered neuromuscular functions compared to healthy individuals. However, the different studies conducted on muscle fatigue in COPD have been done independently of any cognitive solicitation, yet present in most of daily living activities. Therefore, the aim of this research is to evaluate the impact of the disease on neuromuscular fatigue during dual-task situation (simultaneous accomplishment of a muscle contraction and a cognitive task). A better understanding of fatigue in COPD will promote the development of new perspectives in patient management. The hypothesis is that COPD patients will exhibit increased fatigue level (compared to healthy subjects), particularly during dual-task situation. It is assumed that the higher negative effect associated with the dual-task will be related to different neurophysiological mechanisms (i.e., neuromuscular fatigue, autonomic nervous system activity, mental fatigue). |
||||
| Detailed Description |
This study will include three experimental sessions for both COPD patients and healthy participants. These experimental sessions will be performed on three separate days. Each session will last between 1.5 and 2 hours. The first session will correspond to a familiarization session with the different tests that will be performed during the two next sessions. During this first session, different functional tests will be also performed : 1-minute sit-to-stand tests and postural tests, with and without a concomitant cognitive task. The second and third sessions will correspond to experimental sessions during which the participants will accomplish a fatiguing task in single or dual-task situation (randomized order). The cognitive task will be a memory cognitive task, called n-back task. The fatiguing tasks will involve submaximal isometric contractions of the knee extensors performed until task failure. The neuromuscular fatigue will be evaluated regularly during the fatiguing tasks (i.e. about each minute) using the magnetic stimulation of the femoral nerve in order to assess to central and peripheral determinants of the neuromuscular fatigue. Moreover, the autonomic nervous system activity (via cardiac recordings), perceived exertion and cognitive performance (in dual-task situation) will be continuously recorded during the fatiguing tasks. Before and after each fatiguing tasks, several questionnaires will be completed (i.e. mood, motivation, subjective workload) in order to evaluate the psychological determinants of performance. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||
| Condition ICMJE | Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Intervention ICMJE |
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
64 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 30, 2021 | ||||
| Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: COPD patients :
Healthy volunteers :
Exclusion Criteria: COPD patients :
Healthy volunteers:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04028973 | ||||
| Other Study ID Numbers ICMJE | 2019-CHITS-03 2019-A01986-51 ( Other Identifier: IdRCB by ANSM ) |
||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | ||||
| Study Sponsor ICMJE | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | ||||
| Collaborators ICMJE | Université de Toulon | ||||
| Investigators ICMJE |
|
||||
| PRS Account | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | ||||
| Verification Date | November 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||