Recruiting

Respiratory Training

Sponsor:

Laval University

Code:

NCT04201522

Conditions

Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Normocapnic hyperpnoea intervention

Sham intervention

Study Details

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study ID

NCT04201522

Start date

Mar 14, 2017

Status verified date

Dec, 2019

Completion date

Feb, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Training intervention

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

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.

Interventions

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).

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).

Primary outcome measure

  • Change in exercise tolerance (time [seconds]) [ Time Frame: Baseline (week 0), 7 weeks ]

Central Contacts and Locations

Locations

Institut universitaire de cardiologie et de pneumologie de Québec

Recruiting

Québec, Canada, G1V 4G5

Contacts

Principal Investigator:

François Maltais, MD

More Information

Sponsor

Laval University

Last update posted

Dec 17, 2019

Last verified

Dec, 2019

Keywords

  • Respiratory training
  • COPD
  • Muscle oxygenation
  • Muscle fatigue
  • Oxygen kinetic
  • Exercise tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2019-12-17.