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Clinical Trials/NCT02506504
NCT02506504
Completed
Not Applicable

Prevention of Post-exercise Muscle Fatigue Using a Non Invasive Ventilation and Effect on Exercise Training in Severe Patients With COPD. QUADRIVEND Study

Centre Hospitalier Universitaire de Saint Etienne3 sites in 1 country22 target enrollmentJune 25, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Lung Diseases
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
22
Locations
3
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
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2014
End Date
January 14, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

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))

Study Sites (3)

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