Pulmonary Disease, Chronic Obstructive Clinical Trial
— MITOXITRAINOfficial title:
Mitochondrial Adaptations and Oxidative Stress With High Intensity Interval Training During Pulmonary Rehabilitation
Pulmonary rehabilitation (PR) is a validated treatment in patients with Chronic Obstructive Pulmonary Disease (COPD), improving exercise tolerance, quality of life and dyspnea. However, 20 to 30% of patients did not respond to PR and particularly those with chronic hypoxaemia. In most disabled patients, High Intensity Interval training (HIIT) is an alternative to perform exercise training with similar gain in exercise capacity than continuous exercise training. In patients with exercise-induced oxygen desaturation, the repetitions of hypoxia/resaturation phases during intermittent exercise could result in bursts of oxidative stress and induce positive or detrimental effect on mitochondrial function according to the importance in the oxidant stimulus. Few data have ascertained the benefit of HIIT on mitochondrial oxidative capacity (Vmax) in healthy subjects compared to continuous exercise training but no data are available in COPD patients with exercise-induced desaturation, and the change in oxidative stress in such training regimen. The investigators hypothesize that the repetitive bursts of oxidative stress and the improved antioxidant capacity in the course of the training sessions would stimulate mitochondrial adaptations to a larger extent after HIIT than continuous exercise training in severe COPD patients with hypoxemia. Moreover, they will assess the relationship between the change in oxidative stress in blood and in muscle. The clinical relevance of this study will be to ascertain the benefit and the safety of HITT in this subgroup of COPD patients in whom benefit of PR is often weak.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - COPD diagnosed according to Global Obstructive Lung Diagnosis criteria; no exacerbation of COPD in the last month - Referred for a pulmonary rehabilitation program - Exercise-induced oxygen desaturation during a CardioPulmonary Exercise Test, defined as a decrease of oxygen saturation by pulse oximetry >4% from resting value. - Written informed consent - Negative pregnancy test whenever applicable. Exclusion Criteria: - Acute exacerbation of COPD during the last 4 weeks - Physical or psychological inability to perform exercise tests - Life-threatening cardiac events contra-indicating exercise training - Anticoagulant treatment (muscle biopsy) - Pregnant or breastfeeding womenFemmes - Subject with curator, deprived of freedoms or in safeguard of justice - Non covered by the french social security system |
Country | Name | City | State |
---|---|---|---|
France | CHU de Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vmax variation | variation of maximal mitochondrial O2 consumption ( pmol O2.s-1.mg-1) ( with exercise training in both groups | from the beginning to the end of the exercise training program (maximum duration 3 months) | |
Secondary | blood oxidative stress variation | variation with exercise training in both groups of blood oxidative stress, with a composite score obtained by the plasmatic levels of superoxide dismutase, gluthation peroxydase, xanthine oxidase, catalase and myeloperoxidase | from the beginning to the end of the exercise training program (maximum duration 3 months) | |
Secondary | mVO2 variation | variation of muscle oxidative capacity measured by NIRS(affinity constant, min-1) with exercise training in both groups | from the beginning to the end of the exercise training program (maximum duration 3 months) | |
Secondary | Cardiac output variations | variations with exercise training in both groups of cardiac output (L.min-1) measurements during endurance cycling exercise | from the beginning to the end of the exercise training program (maximum duration 3 months) | |
Secondary | Respiratory variations | variations with exercise training in both groups of minute ventilation (L.min-1) measurements during endurance cycling exercise | from the beginning to the end of the exercise training program (maximum duration 3 months) | |
Secondary | muscle oxygen variations | variations with exercise training in both groups of tissue index oxygenation (TIO,%) measured by Near Infrared Spectroscopy during endurance cycling exercise | from the beginning to the end of the exercise training program (maximum duration 3 months) |
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