Evolution of Pulsed Oxygen Saturation During Interval Training Compared to Continuous Training in COPD Patients

Sponsor
Groupe Hospitalier du Havre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05825638
Collaborator
Medrinal Clement (Other), Combret Yann (Other), Machefert Margaux (Other)
12
1
11.7
1

Study Details

Study Description

Brief Summary

A problem often observed during exercise training is oxygen desaturation exclusively during exercise in some patients. In the case of exercise-induced desaturation, it may be suggested to train these patients in interval training to limit exercise-induced desaturation. Interval training consists of alternating active phases of short duration (often 30 seconds to 1 minute) followed by a short active or passive recovery phase of equivalent duration to the previous phase. Investigators therefore hypothesise that interval training on a cycloergometer or treadmill can limit exercise-induced desaturation in COPD patients.

The aim of the study is to observe the evolution of pulsed oxygen saturation between a continuous training session and a interval training session.

Condition or Disease Intervention/Treatment Phase
  • Other: Continuous training session
  • Other: Interval training session

Study Design

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Evolution of Pulsed Oxygen Saturation Throughout an Interval Training Session Compared to a Continuous Training Session in Patients With Chronic Obstructive Pulmonary Disease With Exercise-induced Oxygen Desaturation.
Actual Study Start Date :
Jan 10, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Continuous training session

Other: Continuous training session
Continuous training consists of a 5 minute warm up, 5 minute cool down and 20 minutes of moderate intensity work. The workload is set at 60% of the patient's maximum power

Interval Training session

Other: Interval training session
Interval training consists of a 5-minute warm-up, a 5-minute cool-down and 20 minutes of alternating 60 seconds of high-intensity work (100% of the maximum power recorded in the incremental test that was carried out when the patient was admitted to the pulmonary rehabilitation department) and 60 seconds of unloaded pedalling or rest.

Outcome Measures

Primary Outcome Measures

  1. Difference in oxygen pulsed saturation [One week]

    Difference in minimum saturation during both exercise, the measurement will be performed with a pulse oximeter (Spirodoc, MIR)

Secondary Outcome Measures

  1. Difference in oxygen pulsed saturation [One week]

    Difference in mean pulsed oxygen saturation and the time spent with a pulsed oxygen saturation below 90% during the two training sessions. The measurement will be performed with a pulse oximeter (Spirodoc, MIR)

  2. Difference in peripheral muscle oxygenation [One week]

    Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology. the measurement will be performed with a Near Infrared spectroscopy (Portamon, Artinis Medical Systems)

  3. Difference in respiratory rate [One week]

    Difference in respiratory rate will be measured breath-by-breath using a portable spirometer (Spirodoc, MIR)

  4. Difference in tidal volume [One week]

    Difference in tidal volume will be measured breath-by-breath using a portable spirometer (Spirodoc, MIR)

  5. Difference in inspiratory capacity [One week]

    Difference in inspiratory capacity will be measured using a portable spirometer (Spirodoc, MIR)

  6. Difference in Dyspnea [One week]

    Dyspnea peak during exercise using the modified Borg scale 0-10, 0 no dyspnea, 10 maximal dyspnea

  7. Difference in muscle discomfort [One week]

    Muscle discomfort peak during exercise using the modified Borg scale 0-10, 0 no dyspnea, 10 maximal dyspnea

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • a diagnosis of COPD

  • participating in a pulmonary rehabilitation programme

  • with an exercise-induced desaturation less than 90%

  • no oxygen supplementation

Exclusion Criteria:
  • Under 18 years of age

  • Pregnant woman

  • Person not affiliated to a health insurance regime or not benefiting from a social security regime

  • Patient under curatorship, guardianship or safeguard of justice

  • Patient speaking a language other than French

  • Patient with severe hypoxaemia (SpO2 ≤ 80%) during exercise

  • Patient having had a moderate or severe exacerbation (hospitalisation for respiratory reasons) in the previous 4 weeks

  • Patients with orthopaedic, rheumatic, vascular or neurological pathology limiting their ability to make an effort

  • Breastfeeding women

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier du Havre Le Havre Normandie France 76290

Sponsors and Collaborators

  • Groupe Hospitalier du Havre
  • Medrinal Clement
  • Combret Yann
  • Machefert Margaux

Investigators

  • Principal Investigator: Guillaume Prieur, PT, PhD, Groupe Hospitalier du Havre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guillaume Prieur, Principal Investigator, Groupe Hospitalier du Havre
ClinicalTrials.gov Identifier:
NCT05825638
Other Study ID Numbers:
  • 2022-A02087-36
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Guillaume Prieur, Principal Investigator, Groupe Hospitalier du Havre

Study Results

No Results Posted as of Apr 24, 2023