- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201522
The Effect of Respiratory Training on Exercise Tolerance in COPD (ERTET)
The Effect of Respiratory Training With Normocapnic Hyperpnea on Exercise Tolerance in COPD
Exercise intolerance is one of the key disabling factors in patients with chronic obstructive pulmonary disease (COPD). Although multifactorial, exercise intolerance involves physiological interactions between respiratory and locomotor muscles that may contribute to further reducing exercise tolerance in COPD. The respiratory muscle work during exercise is closely related to breathing and could induce respiratory muscle fatigue in patients with COPD.
Respiratory muscle training is an intervention strategy that is sometimes proposed for some patients with COPD, especially whose with inspiratory muscle weakness. It was reported that inspiratory muscle training improves inspiratory muscle endurance and strength, dyspnea and exercise tolerance. There are two types of inspiratory muscle training, inspiratory muscle training against a resistive loading and normocapnic hyperpnoea. The advantage of normocapnic hyperpnoea compared to resistive training is the possibility to simulate the exercise ventilation level while maintaining stable the partial pressure of arterial carbon dioxide and end-tidal pressure of carbon dioxide and to solicit the inspiratory and expiratory muscles together, which could increase respiratory muscle tolerance and avoid their fatigue during whole-body exercise.
Therefore, the aim of this project is to study the effect of normocapnic hyperpnoea training on exercise tolerance in patients with COPD.
We hypothesize that greater improvement in cycling exercise tolerance will be observed following 6-weeks normocapnic hyperpnoea training compared to a sham intervention in patients with COPD.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ferid Oueslati, PhD
- Phone Number: 3012 +1 (418) 656-8711
- Email: ferid.oueslati@criucpq.ulaval.ca
Study Contact Backup
- Name: Didier Saey, Pht, PhD
- Phone Number: 2614 +1 (418) 656-8711
- Email: Didier.Saey@rea.ulaval.ca
Study Locations
-
-
-
Québec, Canada, G1V 4G5
- Recruiting
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
-
Principal Investigator:
- François Maltais, MD
-
Contact:
- Ferid Oueslati, PhD
- Phone Number: 3012 +14186568711
- Email: ferid.oueslati@criucpq.ulaval.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 40 years;
- Chronic airflow obstruction : FEV1/FVC < 0.7, FEV1 of 30 to 80% predicted, after bronchodilation;
Exclusion Criteria:
- Inability to perform a cycling exercise;
- Diagnosed of one of more comorbidities that may limit exercise tolerance : cardiovascular, metabolic, endocrine, gastrointestinal, renal, neurological or rheumatologically disease;
- Recent COPD exacerbation (< 3 months);
- Recent cancer;
- A daily dose of Prednisone > 10 mg;
- Hypoxemia at rest or during exercise: PaO2 < 60 mmHg or SpO2 ≤ 88%;
- Body mass index > 30 kg/m²;
- Pregnancy;
- Skinfold at intercostal or vastus lateralis muscle > 1.5 cm.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Training intervention
The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance
|
Patients will perform for 6-weeks, 15 min twice daily, 5 days a week at 60% of the peak of minute ventilation, at home by means of a respiratory device (SpiroTiger, Idiag, Fehraltorf, CH).
|
Sham Comparator: Sham intervention
The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance in the training group compared to the sham group.
|
Patients will perform for 6-weeks, 15 min twice daily, 5 days a week at rest's minute ventilation, at home by means of a respiratory device (SpiroTiger, Idiag, Fehraltorf, CH).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in exercise tolerance (time [seconds])
Time Frame: Baseline (week 0), 7 weeks
|
Constant workrate cycling exercise time at 75% of power peak.
|
Baseline (week 0), 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minute ventilation responses (flow [L/min])
Time Frame: Baseline (week 0), 7 weeks
|
Minute ventilation during the constant workrate cycling exercise will be determined using a portable gas analysis system.
|
Baseline (week 0), 7 weeks
|
Change in respiratory muscle strength (pressure [cm H2O])
Time Frame: Baseline (week 0), 7 weeks
|
Maximal inspiratory and expiratory pressures will be assessed with a portable manometer before and at end the constant workrate cycling exercise.
|
Baseline (week 0), 7 weeks
|
Change in muscle oxygenation (from baseline [%])
Time Frame: Baseline (week 0), 7 weeks
|
Deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of intercostal and vastus lateralis muscle during the constant workrate cycling exercise
|
Baseline (week 0), 7 weeks
|
Change in cardiac output (flow [L/min])
Time Frame: Baseline (week 0), 7 weeks
|
Arterial blood pressures and cardiac output will be non-invasively measured by a finger photoplethysmography device during the constant workrate cycling exercise
|
Baseline (week 0), 7 weeks
|
Isometric muscle strength (force [Kg])
Time Frame: Baseline (week 0), 7 weeks
|
Maximum voluntary isometric contraction with twitch tension induced by supramaximal magnetic stimulation of the femoral nerve will be realized before and 15 minutes after the constant workrate cycling exercise.
|
Baseline (week 0), 7 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francois Maltais, MD, Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER 21411
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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