Prevention of Post-exercise Muscle Fatigue and Effect on Exercise Training in Severe Patients With COPD.

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

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-25

Study Completion Date

2019-01-14

Brief Summary

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In patients with severe Chronic Obstructive Pulmonary Disease (COPD), exercise tolerance is severely impaired due to a ventilatory limitation, levelling off the intensity of exercise. This reduces the physiological benefit of pulmonary rehabilitation. In these patients, it is then proposed to add an Inspiratory Pressure Support (IPS) in order to increase the intensity and the duration of every training session. In a preliminary study, the investigators showed that IPS applied during an exhaustive cycling exercise allowed to prevent the onset of post-exercise quadriceps fatigue evaluated by the endurance time to isotonic quadriceps contractions (TlimQ).

The aim of this study is to determine the relationship between the prevention of post-exercise fatigue (TlimQ) and the change in training load (intensity x time x number of sessions) during a pulmonary rehabilitation programme. At the beginning of the training programme, 25 patients will be evaluated for TlimQ after a cycling exercise (70% maximal workload) with and without IPS in random order. The training load was then monitored at every exercise session of the programme.

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Detailed Description

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Conditions

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Obstructive Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Inspiratory help then sham ventilation

The initial evaluation is performed using an Inspiratory Pressure Support. After the training, the final evaluation is performed using an Inspiratory help (sham ventilation).

Group Type EXPERIMENTAL

Inspiratory help then sham ventilation

Intervention Type DEVICE

The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.

Sham ventilation then Inspiratory help

The initial evaluation is performed using an inspiratory help (sham ventilation).

After the training, the final evaluation is performed using an Inspiratory Pressure Support.

Group Type EXPERIMENTAL

Sham ventilation then Inspiratory help

Intervention Type DEVICE

The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.

Interventions

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Inspiratory help then sham ventilation

The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.

Intervention Type DEVICE

Sham ventilation then Inspiratory help

The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Severe COPD patients in stable condition (Gold class 3 or 4)
* Ventilatory limitation to exercise during the incremental cardiopulmonary exercise test (at least one of the following criteria) :
* No breathing reserve
* Exercise hypoventilation (increase arterial PCO2\> 5 mmHg)
* Maximal workload \<50 Watts

Exclusion Criteria

* IPS not tolerated during a preliminary cycling exercise test
* Enable to perform the exercise tests or the rehabilitation programme
* Decline to participate

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No