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

NCT02506504 | Completed

• 2 other identifiers: 13081892014-A00145-42
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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.

Conditions

Obstructive Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• variation TlimQ of post-exercise without and with IPS

  Visit 3 (week 1)

• relationship between the change in the endurance to cycling exercise without and with IPS and the change in TlimQ

  Visit 24 (week 8)

• 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 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)

Study Arms (2)

Inspiratory help then sham ventilation

EXPERIMENTAL

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

Sham ventilation then Inspiratory help

EXPERIMENTAL

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

Interventions

Inspiratory help then sham ventilation DEVICE

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.

Inspiratory help then sham ventilation

Sham ventilation then Inspiratory help DEVICE

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.

Sham ventilation then Inspiratory help

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• IPS not tolerated during a preliminary cycling exercise test
• Enable to perform the exercise tests or the rehabilitation programme
• Decline to participate

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Clinique Cardio-pneumologique de Durtol

Durtol, 63000, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Claude BARTHELEMY, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 23, 2015
• Study Start: June 25, 2014
• Primary Completion: October 22, 2018
• Study Completion: January 14, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)