High Intensity Interval Training and Muscle Adaptations During PR

NCT05858463 | Unknown

• 2 other identifiers: AOI 2022 COSTES2022-A02468-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Disease, Chronic Obstructive; Mitochondrial Alteration; Oxygen Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• blood oxidative stress variation

  from the beginning to the end of the exercise training program (maximum duration 3 months)

• mVO2 variation

  from the beginning to the end of the exercise training program (maximum duration 3 months)

• Cardiac output variations

  from the beginning to the end of the exercise training program (maximum duration 3 months)

• Respiratory variations

  from the beginning to the end of the exercise training program (maximum duration 3 months)

• muscle oxygen variations

  from the beginning to the end of the exercise training program (maximum duration 3 months)

Study Arms (2)

Intervention group

EXPERIMENTAL

High Intensity Interval training: 1 min at maximal workload followed by 1 min rest, repeated during a maximum of 40 min.

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

Other: Modality of exercise training

Interventions

Modality of exercise training OTHER

muscle adaptations following intermittent high intensity interval exercise training and continuous low intensity exercise training

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Frédéric Costes

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparison of 2 exercise training strategies

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 15, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-03

Locations

FR (1)