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The Effect of Respiratory Training on Exercise Tolerance in COPD

NCT ID: NCT04201522

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-14

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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Respiratory training COPD Muscle oxygenation Muscle fatigue Oxygen kinetic Exercise tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a randomized, controlled, parallel-group trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients will be randomized to training group or sham group.

Study Groups

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Training intervention

The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance

Group Type ACTIVE_COMPARATOR

Normocapnic hyperpnoea intervention

Intervention Type OTHER

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 intervention

The effect of 6-weeks of respiratory training with normocapnic hyperpnoea on exercise tolerance in the training group compared to the sham group.

Group Type SHAM_COMPARATOR

Sham intervention

Intervention Type OTHER

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).

Interventions

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Normocapnic hyperpnoea intervention

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

Sham intervention

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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oueslati, Ferid, PhD

UNKNOWN

Sponsor Role collaborator

Saey, Didier, M.D.

INDIV

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Francois Maltlais

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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François Maltais, MD

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Locations

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Institut universitaire de cardiologie et de pneumologie de Québec

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ferid Oueslati, PhD

Role: CONTACT

Phone: +1 (418) 656-8711

Email: [email protected]

Didier Saey, Pht, PhD

Role: CONTACT

Phone: +1 (418) 656-8711

Email: [email protected]

Facility Contacts

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Ferid Oueslati, PhD

Role: primary

Other Identifiers

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CER 21411

Identifier Type: -

Identifier Source: org_study_id