Pulmonary Disease, Chronic ObstructiveERTETNCT04201522
The Effect of Respiratory Training on Exercise Tolerance in COPD
A study testing Normocapnic hyperpnoea intervention in people with Pulmonary Disease, Chronic Obstructive, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Normocapnic hyperpnoea intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2017to Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years;
- Chronic airflow obstruction : FEV1/FVC < 0.7, FEV1 of 30 to 80% predicted, after bronchodilation;
Who cannot join
- 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%;
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- Body mass index > 30 kg/m²;
- Pregnancy;
- Skinfold at intercostal or vastus lateralis muscle > 1.5 cm.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
Ferid Oueslati, PhD, +14186568711 ext. 3012, ferid.oueslati@criucpq.ulaval.ca
François Maltais, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Normocapnic hyperpnoea intervention, Sham intervention
- Keywords
- Respiratory training, COPD, Muscle oxygenation, Muscle fatigue, Oxygen kinetic, Exercise tolerance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normocapnic hyperpnoea interventionOther
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 interventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Training intervention | Active comparator | The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance Receives: Other: Normocapnic hyperpnoea intervention |
| Sham intervention | Sham comparator | The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance in the training group compared to the sham group. Receives: Other: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise tolerance (time [seconds])
Constant workrate cycling exercise time at 75% of power peak.
Measured: Baseline (week 0), 7 weeks
Secondary outcomes (5)
Minute ventilation responses (flow [L/min])
Minute ventilation during the constant workrate cycling exercise will be determined using a portable gas analysis system.
Measured: Baseline (week 0), 7 weeks
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.
Measured: Baseline (week 0), 7 weeks
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
Measured: Baseline (week 0), 7 weeks
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
Measured: Baseline (week 0), 7 weeks
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.
Measured: Baseline (week 0), 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start14 Mar 2017
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, controlled, parallel-group trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Oueslati, Ferid, PhD, Saey, Didier, M.D.
- Responsible party
- Principal investigator, Francois Maltlais, Laval University
- Investigators
- François Maltais, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201522
- Sponsor's protocol ID
- CER 21411
- Acronym
- ERTET
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 17 Dec 2019
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Training With Normocapnic Hyperpnea on Exercise Tolerance in COPD
- ClinicalTrials.gov ID
- NCT04201522
- Acronym / sponsor ID
- ERTET / CER 21411
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Respiratory training, COPD, Muscle oxygenation, Muscle fatigue, Oxygen kinetic, Exercise tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Oueslati, Ferid, PhD, Saey, Didier, M.D.
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 17 Dec 2019 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a randomized, controlled, parallel-group trial.
| Arm | Type | Receives |
|---|---|---|
| Training intervention | Active comparator | Other: Normocapnic hyperpnoea interventionThe effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance |
| Sham intervention | Sham comparator | Other: Sham interventionThe effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance in the training group compared to the sham group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 40 years;
- Chronic airflow obstruction : FEV1/FVC < 0.7, FEV1 of 30 to 80% predicted, after bronchodilation;
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| Normocapnic hyperpnoea interventionPatients 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). | Other | Training intervention |
| Sham interventionPatients 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). | Other | Sham intervention |
Primary outcome
Change in exercise tolerance (time [seconds])
Time frame: Baseline (week 0), 7 weeks
Constant workrate cycling exercise time at 75% of power peak.
5 secondary outcomes
Minute ventilation responses (flow [L/min])
Time frame: Baseline (week 0), 7 weeks
Change in respiratory muscle strength (pressure [cm H2O])
Time frame: Baseline (week 0), 7 weeks
Change in muscle oxygenation (from baseline [%])
Time frame: Baseline (week 0), 7 weeks
Change in cardiac output (flow [L/min])
Time frame: Baseline (week 0), 7 weeks
Isometric muscle strength (force [Kg])
Time frame: Baseline (week 0), 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Individual participant dataSharing planned: No
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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.
François Maltais, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normocapnic hyperpnoea intervention in people with Pulmonary Disease, Chronic Obstructive, run by Laval University at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferid Oueslati, PhD (+1 (418) 656-8711 ext. 3012, ferid.oueslati@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise tolerance (time [seconds]) (time frame: Baseline (week 0), 7 weeks). 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 17 Dec 2019.