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: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Normocapnic hyperpnoea intervention; Other: Sham intervention

• Study Type: Interventional
• Enrollment (Anticipated): 40
• 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

• Canada
  • 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: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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	Other: 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 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise tolerance (time [seconds])	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])	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])	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 [%])	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])	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])	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: Laval University
• Collaborators: Saey, Didier, M.D.; Oueslati, Ferid, PhD
• 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): March 14, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: COPD; Exercise tolerance; Respiratory training; Muscle oxygenation; Muscle fatigue; Oxygen kinetic
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CER 21411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No