- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05825638
Evolution of Pulsed Oxygen Saturation During Interval Training Compared to Continuous Training in COPD Patients
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Normandy
-
Le Havre, Normandy, France, 76290
- Groupe Hospitalier Du Havre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in oxygen pulsed saturation
Time Frame: One week
|
Difference in minimum saturation during both exercise, the measurement will be performed with a pulse oximeter (Spirodoc, MIR)
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in oxygen pulsed saturation
Time Frame: 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)
|
One week
|
|
Difference in peripheral muscle oxygenation
Time Frame: 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)
|
One week
|
|
Difference in respiratory rate
Time Frame: One week
|
Difference in respiratory rate will be measured breath-by-breath using a portable spirometer (Spirodoc, MIR)
|
One week
|
|
Difference in tidal volume
Time Frame: One week
|
Difference in tidal volume will be measured breath-by-breath using a portable spirometer (Spirodoc, MIR)
|
One week
|
|
Difference in inspiratory capacity
Time Frame: One week
|
Difference in inspiratory capacity will be measured using a portable spirometer (Spirodoc, MIR)
|
One week
|
|
Difference in Dyspnea
Time Frame: One week
|
Dyspnea peak during exercise using the modified Borg scale 0-10, 0 no dyspnea, 10 maximal dyspnea
|
One week
|
|
Difference in muscle discomfort
Time Frame: One week
|
Muscle discomfort peak during exercise using the modified Borg scale 0-10, 0 no dyspnea, 10 maximal dyspnea
|
One week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume Prieur, PT, PhD, Groupe Hospitalier Du Havre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A02087-36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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