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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Obstructive Lung Diseases

Treatments: Device: Sham ventilation then Inspiratory help; Device: Inspiratory help then sham ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02506504

2014-A00145-42 (Other Identifier)

1308189

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Inspiratory help then sham ventilation

Experimental group

Description:

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

Treatment:

Device: Inspiratory help then sham ventilation

Sham ventilation then Inspiratory help

Experimental group

Description:

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

Treatment:

Device: Sham ventilation then Inspiratory help