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

Not Applicable

Completed

• Conditions: Obstructive Lung Diseases
• Interventions: Device: Inspiratory help then sham ventilation; Device: Sham ventilation then Inspiratory help

• Registration Number: NCT02506504
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-25
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Primary Completion: 2018-10-22
• Study Completion: 2019-01-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory help then sham ventilation	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).
Sham ventilation then Inspiratory help	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.

Primary Outcome Measures

Name	Time	Method
Strength of the correlation between the change of TlimQ (min) and the training load calculated as intensity (in watts) x duration of the session (minute) x number of sessions	Visit 24 (week 8)	At the beginning of the programme, we evaluate the influence of IPS on TlimQ (visits 2 and 3). After the training period, we repeated the same evaluations (visits 23 and 24). Then, we will compare this difference before and after the training period, and we will seek for a relation with the training load.

Secondary Outcome Measures

Name	Time	Method
variation of TlimQ after a cycling exercice untill fatigue without IPS at the beginning and the end of pulmonary rehabilitation evaluated by the endurance time to isotonic quadriceps contractions	Visit 24 (week 8)
relationship between the change in the endurance to cycling exercise without and with IPS and the change in TlimQ	Visit 24 (week 8)	we will compare the difference in endurance to exercise with IPS and the difference in endurance to isotonic quadriceps contractions
variation TlimQ of post-exercise without and with IPS	Visit 3 (week 1)	We compare the endurance time to isotonic quadriceps contractions after a cycling exercice until exhaustion with and without IPS, at the beginning of the training period.
relationship between the change in the endurance to cycling exercise with IPS and the change in TlimQ	Visit 24 (week 8)	we will seek for a relationship between the changes in the endurance time to cycling exercise without or with IPS and the variation in endurance to isotonic quadriceps contractions following cycling exercise
variation of TlimQ after a cycling exercice untill fatigue with IPS at the beginning and the end of pulmonary rehabilitation evaluated by the endurance time to isotonic quadriceps contractions	Visit 24 (week 8)

Trial Locations

Locations (3)

Clinique Cardio-pneumologique de Durtol; 🇫🇷 Durtol, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France