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

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

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 Overview

• Status: Completed
• Conditions: Obstructive Lung Diseases
• Intervention / Treatment: Device: Inspiratory help then sham ventilation; Device: Sham ventilation then Inspiratory help

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Durtol, France, 63000
    • Clinique Cardio-pneumologique de Durtol
  • Saint-Etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Inspiratory help then sham ventilation; 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.
Experimental: 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.	Device: Sham ventilation then Inspiratory help; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 24 (week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 3 (week 1)
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	Visit 24 (week 8)
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	Visit 24 (week 8)
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)
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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start: June 25, 2014
• Primary Completion (Actual): October 22, 2018
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: 1308189; 2014-A00145-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No