The Effect of Respiratory Training on Exercise Tolerance in COPD

NCT04201522 | Unknown

• 1 other identifier: CER 21411
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in exercise tolerance (time [seconds])

  Constant workrate cycling exercise time at 75% of power peak.

  Baseline (week 0), 7 weeks

Secondary Outcomes (5)

• Minute ventilation responses (flow [L/min])

  Baseline (week 0), 7 weeks

• Change in respiratory muscle strength (pressure [cm H2O])

  Baseline (week 0), 7 weeks

• Change in muscle oxygenation (from baseline [%])

  Baseline (week 0), 7 weeks

• Change in cardiac output (flow [L/min])

  Baseline (week 0), 7 weeks

• Isometric muscle strength (force [Kg])

  Baseline (week 0), 7 weeks

Study Arms (2)

Training intervention

ACTIVE COMPARATOR

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

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.

Other: Sham intervention

Interventions

Normocapnic hyperpnoea intervention 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).

Training intervention

Sham intervention 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).

Sham intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years;
• Chronic airflow obstruction : FEV1/FVC \< 0.7, FEV1 of 30 to 80% predicted, after bronchodilation;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Oueslati, Ferid, PhD: collaborator
• Saey, Didier, M.D.: collaborator

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François Maltais, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferid Oueslati, PhD

CONTACT

+1 (418) 656-8711; ferid.oueslati@criucpq.ulaval.ca

Didier Saey, Pht, PhD

CONTACT

+1 (418) 656-8711; Didier.Saey@rea.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomized to training group or sham group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: The study is a randomized, controlled, parallel-group trial.

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 17, 2019
• Study Start: March 14, 2017
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)