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Completed

NCT Number: NCT02506504

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

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.

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Key information

Conditions

Obstructive Lung Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

    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

  1. variation TlimQ of post-exercise without and with IPS

    Time frame: Visit 3 (week 1)

    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.

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

    Time frame: Visit 24 (week 8)

    we will compare the difference in endurance to exercise with IPS and the difference in endurance to isotonic quadriceps contractions

  3. relationship between the change in the endurance to cycling exercise with IPS and the change in TlimQ

    Time frame: Visit 24 (week 8)

    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

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: QUADRIVEND

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jul 23, 2015
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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