CPOD Patient's Tolerance of Intermittent Exercise With Inter-exercise Recovery Under Normoxic Hypoxia

NCT07072975 | Not Yet Recruiting

• 1 other identifier: PI2025_843_0029
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise retraining improves the prognosis and quality of life of patients with chronic lung or circulatory diseases. However, exercise intolerance may be caused by excessive ventilatory. Exposure to oxygen-replete air reduces this ventilatory overload, improves sleep and enhances responses to exercise. This study examine the impact of the acute manipulation of oxygen availability during inter-exercise recovery period of an intermittent cycling exercise on perceptual responses. this randomized, controlled, study include adult patient with COPD. On separate days, 50 patients with COPD completed four sets of 4-min at 85% of VO2peak intercept by 3-min of passive recovery in two randomized between-sets recovery conditions. Rating exertion perception, gaz exchanges, heart rate, sleep quality and nocturnal heart rate variability were assessed. Hypoxic exposure during inter-repetition recovery phases would reduce the ventilatory load during exercise. What's more, patients would not be forced to perform the sporting gesture in a restricted space or wearing a mask, limiting dyspnea and the perceived difficulty of the effort. Lastly, the induction of hypoxic stress during the re-training session helped to improve patients' sleep.

Conditions

Intermittent Hypoxia; Exercise Recovery; Intermittent Exercise; Rating Exertion Perception; Sleep

Keywords

intermittent hypoxia; exercise recovery; intermittent exercise; rating exertion perception; sleep

Outcome Measures

Primary Outcomes (1)

• Perception Exertion score with CR10

  The modified Borg CR10 RPE scale measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).

  day 1

Secondary Outcomes (1)

• Cardiorespiratory responses to exercise

  day 1

Study Arms (2)

comparator

EXPERIMENTAL

On separate days, 50 patients with COPD completed four sets of 4-min at 85% of VO2peak intercept by 3-min of passive recovery in two randomized between-sets recovery conditions. Rating exertion perception, gaz exchanges, heart rate, sleep quality and nocturnal heart rate variability were assessed.

Other: Normobaric hypoxia

sham

SHAM COMPARATOR

Other: normoxic condition

Interventions

Normobaric hypoxia OTHER

Normobaric hypoxia (inspired oxygen fraction of 12.9%) applied between-sets recovery periods

comparator

normoxic condition OTHER

Between-sets recovery periods under normoxic condition

sham

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• from 40 to 60 years
• follow-up in the pneumology unit of CHU Amiens - Picardie
• Chronic Obstructive Pulmonary Disease stade II
• Body mass index from 20 to 30 kg.m-2
• Tiffeneau index \< 70% of predicted value
• FEV1 from 50 to 80% of predicted values
• Smoking cessation since at least 1 week
• Sedentary or physical active
• Affiliate to social security
• Written consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHRU Amiens

Amiens, 80480, France

Location

Central Study Contacts

Emeric Thiesset, MD

CONTACT

33+322088051; thiesset.emeric@chu-amiens.fr

Study Design

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

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)