Pulmonary Disease, Chronic ObstructiveMITOXITRAINNCT05858463
High Intensity Interval Training and Muscle Adaptations During PR
A study testing Modality of exercise training in people with Pulmonary Disease, Chronic Obstructive and Mitochondrial Alteration, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Mitochondrial Alteration, Oxygen Deficiency
- What is being tested?
- Modality of exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Frédéric Costes
About this study
Official 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.
Read the detailed description
The investigators will conduct an open-label randomized controlled trial in 2 parallel groups of COPD patients referred for a pulmonary rehabilitation programme (PR). After inclusion the patients will be randomized in HIIT (IG) or continuous groups (CG). Two visits will be planned before and 2 immediately after completion of PR, with similar tests.
- A cycling endurance test performed until exhaustion CG: exercise at 75% of predetermined maximal workload (Wmax) IG: 1 min at Wmax followed with 1 min unloaded pedaling, up to a maximal duration of 30 minutes. During this test, oxygen consumption, minute ventilation, cardiac output (thoracic impedance), pulse oxygen saturation and muscle oxygen saturation (NIRS) will be recorded continuously. Markers of oxidative stress will be measured before and at the end of the cycling test (5 ml blood).
- The mitochondrial oxidative capacity of the quadriceps will be measured on a separate day. A 20 mg biopsy of the vastus lateralis will be obtained under local anaesthesia using a biopsy needle. Maximal mitochondrial oxygen consumption (Vmax) will be measured on fresh permeabilized fibers (10 mg) using high resolution respirometry (Oroboros®), and 10 mg will be frozen for determination of oxidative markers. Vmax was also determined non invasively by the recovery of muscle oxygen saturation (NIRS) during repetitive brief arterial occlusions (according to the method described by Ryan and coll).
As part of PR, the participants will complete 20 sessions of exercise training (HIIT or continuous). The exercise intensity will be adapted weekly according to the participant's sensation. In the IG, the sessions will not exceed 40 min (20 min of active exercise).
- Being tested
- Modality of exercise training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modality of exercise trainingOther
muscle adaptations following intermittent high intensity interval exercise training and continuous low intensity exercise training
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | High Intensity Interval training: 1 min at maximal workload followed by 1 min rest, repeated during a maximum of 40 min. Receives: Other: Modality of exercise training |
| Control group | Active comparator | Low intensity continuous exercise training set at the level of the ventilatory threshold, lasting for a maximum of 40 min Receives: Other: Modality of exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vmax variation
variation of maximal mitochondrial O2 consumption ( pmol O2.s-1.mg-1) ( with exercise training in both groups
Measured: from the beginning to the end of the exercise training program (maximum duration 3 months)
Secondary outcomes (5)
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
Measured: from the beginning to the end of the exercise training program (maximum duration 3 months)
mVO2 variation
variation of muscle oxidative capacity measured by NIRS(affinity constant, min-1) with exercise training in both groups
Measured: from the beginning to the end of the exercise training program (maximum duration 3 months)
Cardiac output variations
variations with exercise training in both groups of cardiac output (L.min-1) measurements during endurance cycling exercise
Measured: from the beginning to the end of the exercise training program (maximum duration 3 months)
Respiratory variations
variations with exercise training in both groups of minute ventilation (L.min-1) measurements during endurance cycling exercise
Measured: from the beginning to the end of the exercise training program (maximum duration 3 months)
muscle oxygen variations
variations with exercise training in both groups of tissue index oxygenation (TIO,%) measured by Near Infrared Spectroscopy during endurance cycling exercise
Measured: from the beginning to the end of the exercise training program (maximum duration 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study startSep 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison of 2 exercise training strategies
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Costes, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858463
- Sponsor's protocol ID
- AOI 2022 COSTES
- Other IDs
- 2022-A02468-35
- Acronym
- MITOXITRAIN
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Adaptations and Oxidative Stress With High Intensity Interval Training During Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT05858463
- Acronym / sponsor ID
- MITOXITRAIN / AOI 2022 COSTES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct an open-label randomized controlled trial in 2 parallel groups of COPD patients referred for a pulmonary rehabilitation programme (PR). After inclusion the patients will be randomized in HIIT (IG) or continuous groups (CG). Two visits will be planned before and 2 immediately after completion of PR, with similar tests.
- A cycling endurance test performed until exhaustion CG: exercise at 75% of predetermined maximal workload (Wmax) IG: 1 min at Wmax followed with 1 min unloaded pedaling, up to a maximal duration of 30 minutes. During this test, oxygen consumption, minute ventilation, cardiac output (thoracic impedance), pulse oxygen saturation and muscle oxygen saturation (NIRS) will be recorded continuously. Markers of oxidative stress will be measured before and at the end of the cycling test (5 ml blood).
- The mitochondrial oxidative capacity of the quadriceps will be measured on a separate day. A 20 mg biopsy of the vastus lateralis will be obtained under local anaesthesia using a biopsy needle. Maximal mitochondrial oxygen consumption (Vmax) will be measured on fresh permeabilized fibers (10 mg) using high resolution respirometry (Oroboros®), and 10 mg will be frozen for determination of oxidative markers. Vmax was also determined non invasively by the recovery of muscle oxygen saturation (NIRS) during repetitive brief arterial occlusions (according to the method described by Ryan and coll).
As part of PR, the participants will complete 20 sessions of exercise training (HIIT or continuous). The exercise intensity will be adapted weekly according to the participant's sensation. In the IG, the sessions will not exceed 40 min (20 min of active exercise).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparison of 2 exercise training strategies
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Modality of exercise trainingHigh Intensity Interval training: 1 min at maximal workload followed by 1 min rest, repeated during a maximum of 40 min. |
| Control group | Active comparator | Other: Modality of exercise trainingLow intensity continuous exercise training set at the level of the ventilatory threshold, lasting for a maximum of 40 min |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modality of exercise trainingmuscle adaptations following intermittent high intensity interval exercise training and continuous low intensity exercise training | Other | Control group, Intervention group |
Primary outcome
Vmax variation
Time frame: from the beginning to the end of the exercise training program (maximum duration 3 months)
variation of maximal mitochondrial O2 consumption ( pmol O2.s-1.mg-1) ( with exercise training in both groups
5 secondary outcomes
blood oxidative stress variation
Time frame: from the beginning to the end of the exercise training program (maximum duration 3 months)
mVO2 variation
Time frame: from the beginning to the end of the exercise training program (maximum duration 3 months)
Cardiac output variations
Time frame: from the beginning to the end of the exercise training program (maximum duration 3 months)
Respiratory variations
Time frame: from the beginning to the end of the exercise training program (maximum duration 3 months)
muscle oxygen variations
Time frame: from the beginning to the end of the exercise training program (maximum duration 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Costes principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modality of exercise training in people with Pulmonary Disease, Chronic Obstructive and Mitochondrial Alteration, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vmax variation (time frame: from the beginning to the end of the exercise training program (maximum duration 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.