Prevention of Post-exercise Muscle Fatigue and Effect on Exercise Training in Severe Patients With COPD. (QUADRIVEND)
Primary Purpose
Obstructive Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Inspiratory help then sham ventilation
Sham ventilation then Inspiratory help
Sponsored by
About this trial
This is an interventional other trial for Obstructive Lung Diseases
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
Sites / Locations
- CHU de Clermont-Ferrand
- Clinique Cardio-pneumologique de Durtol
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Inspiratory help then sham ventilation
Sham ventilation then Inspiratory help
Arm 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).
The initial evaluation is performed using an inspiratory help (sham ventilation). After the training, the final evaluation is performed using an Inspiratory Pressure Support.
Outcomes
Primary Outcome Measures
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
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
variation TlimQ of post-exercise without and with IPS
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 without and with IPS and the change in TlimQ
we will compare the difference in endurance to exercise with IPS and the difference in endurance to isotonic quadriceps contractions
relationship between the change in the endurance to cycling exercise with IPS and the change in TlimQ
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 without IPS at the beginning and the end of pulmonary rehabilitation evaluated by the endurance time to isotonic quadriceps contractions
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
Full Information
NCT ID
NCT02506504
First Posted
July 16, 2015
Last Updated
April 1, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02506504
Brief Title
Prevention of Post-exercise Muscle Fatigue and Effect on Exercise Training in Severe Patients With COPD.
Acronym
QUADRIVEND
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2014 (undefined)
Primary Completion Date
October 22, 2018 (Actual)
Study Completion Date
January 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Lung Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory help then sham ventilation
Arm Type
Experimental
Arm 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).
Arm Title
Sham ventilation then Inspiratory help
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Inspiratory help then sham ventilation
Intervention Description
The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.
Intervention Type
Device
Intervention Name(s)
Sham ventilation then Inspiratory help
Intervention Description
The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Visit 24 (week 8)
Secondary Outcome Measure Information:
Title
variation TlimQ of post-exercise without and with IPS
Description
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.
Time Frame
Visit 3 (week 1)
Title
relationship between the change in the endurance to cycling exercise without and with IPS and the change in TlimQ
Description
we will compare the difference in endurance to exercise with IPS and the difference in endurance to isotonic quadriceps contractions
Time Frame
Visit 24 (week 8)
Title
relationship between the change in the endurance to cycling exercise with IPS and the change in TlimQ
Description
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
Time Frame
Visit 24 (week 8)
Title
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
Time Frame
Visit 24 (week 8)
Title
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
Time Frame
Visit 24 (week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude BARTHELEMY, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Clinique Cardio-pneumologique de Durtol
City
Durtol
ZIP/Postal Code
63000
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Post-exercise Muscle Fatigue and Effect on Exercise Training in Severe Patients With COPD.
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