The Effect of Respiratory Training on Exercise Tolerance in COPD (ERTET)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Normocapnic hyperpnoea intervention
Sham intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Respiratory training, COPD, Muscle oxygenation, Muscle fatigue, Oxygen kinetic, Exercise tolerance
Eligibility Criteria
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.
Sites / Locations
- Institut universitaire de cardiologie et de pneumologie de QuébecRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Training intervention
Sham intervention
Arm Description
The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance
The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance in the training group compared to the sham group.
Outcomes
Primary Outcome Measures
Change in exercise tolerance (time [seconds])
Constant workrate cycling exercise time at 75% of power peak.
Secondary Outcome Measures
Minute ventilation responses (flow [L/min])
Minute ventilation during the constant workrate cycling exercise will be determined using a portable gas analysis system.
Change in respiratory muscle strength (pressure [cm H2O])
Maximal inspiratory and expiratory pressures will be assessed with a portable manometer before and at end the constant workrate cycling exercise.
Change in muscle oxygenation (from baseline [%])
Deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of intercostal and vastus lateralis muscle during the constant workrate cycling exercise
Change in cardiac output (flow [L/min])
Arterial blood pressures and cardiac output will be non-invasively measured by a finger photoplethysmography device during the constant workrate cycling exercise
Isometric muscle strength (force [Kg])
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.
Full Information
NCT ID
NCT04201522
First Posted
November 26, 2019
Last Updated
December 16, 2019
Sponsor
Laval University
Collaborators
Oueslati, Ferid, PhD, Saey, Didier, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT04201522
Brief Title
The Effect of Respiratory Training on Exercise Tolerance in COPD
Acronym
ERTET
Official Title
The Effect of Respiratory Training With Normocapnic Hyperpnea on Exercise Tolerance in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Oueslati, Ferid, PhD, Saey, Didier, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Respiratory training, COPD, Muscle oxygenation, Muscle fatigue, Oxygen kinetic, Exercise tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a randomized, controlled, parallel-group trial.
Masking
Participant
Masking Description
Patients will be randomized to training group or sham group.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training intervention
Arm Type
Active Comparator
Arm Description
The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance
Arm Title
Sham intervention
Arm Type
Sham Comparator
Arm Description
The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance in the training group compared to the sham group.
Intervention Type
Other
Intervention Name(s)
Normocapnic hyperpnoea intervention
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in exercise tolerance (time [seconds])
Description
Constant workrate cycling exercise time at 75% of power peak.
Time Frame
Baseline (week 0), 7 weeks
Secondary Outcome Measure Information:
Title
Minute ventilation responses (flow [L/min])
Description
Minute ventilation during the constant workrate cycling exercise will be determined using a portable gas analysis system.
Time Frame
Baseline (week 0), 7 weeks
Title
Change in respiratory muscle strength (pressure [cm H2O])
Description
Maximal inspiratory and expiratory pressures will be assessed with a portable manometer before and at end the constant workrate cycling exercise.
Time Frame
Baseline (week 0), 7 weeks
Title
Change in muscle oxygenation (from baseline [%])
Description
Deoxyhemoglobin/myoglobin concentrations measured by near-infrared spectroscopy of intercostal and vastus lateralis muscle during the constant workrate cycling exercise
Time Frame
Baseline (week 0), 7 weeks
Title
Change in cardiac output (flow [L/min])
Description
Arterial blood pressures and cardiac output will be non-invasively measured by a finger photoplethysmography device during the constant workrate cycling exercise
Time Frame
Baseline (week 0), 7 weeks
Title
Isometric muscle strength (force [Kg])
Description
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.
Time Frame
Baseline (week 0), 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferid Oueslati, PhD
Phone
+1 (418) 656-8711
Ext
3012
Email
ferid.oueslati@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Didier Saey, Pht, PhD
Phone
+1 (418) 656-8711
Ext
2614
Email
Didier.Saey@rea.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Maltais, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferid Oueslati, PhD
Phone
+14186568711
Ext
3012
Email
ferid.oueslati@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
François Maltais, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Respiratory Training on Exercise Tolerance in COPD
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