Prevention of Post-exercise Muscle Fatigue Using a Non Invasive Ventilation and Effect on Exercise Training in Severe Patients With COPD. QUADRIVEND Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 6
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: Inspiratory help then sham ventilation (Device)
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.
Intervention: Sham ventilation then Inspiratory help (Device)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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))
- variation TlimQ of post-exercise without and with IPS(Visit 3 (week 1))
- relationship between the change in the endurance to cycling exercise with IPS and the change in TlimQ(Visit 24 (week 8))
- 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))