Clinical trial NCT02506504: Prevention of Post-exercise Muscle Fatigue and Effect on Exercise Training in Severe Patients With COPD.
Official title: Prevention of Post-exercise Muscle Fatigue Using a Non Invasive Ventilation and Effect on Exercise Training in Severe Patients With COPD. QUADRIVEND Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Lung Diseases
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Visit 24 (week 8)
Secondary outcomes:
measure: variation TlimQ of post-exercise without and with IPS
timeFrame: Visit 3 (week 1)
measure: relationship between the change in the endurance to cycling exercise without and with IPS and the change in TlimQ
timeFrame: Visit 24 (week 8)
measure: relationship between the change in the endurance to cycling exercise with IPS and the change in TlimQ
timeFrame: Visit 24 (week 8)
measure: 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
timeFrame: Visit 24 (week 8)
measure: 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
timeFrame: Visit 24 (week 8)
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Durtol
country: France
facility: Clinique Cardio-pneumologique de Durtol
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Jean-Claude BARTHELEMY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: