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

COPD Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825638
• Other study ID #: 2022-A02087-36
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier du Havre
• Contact: Guillaume Prieur, PT, PhD
• Phone: +33617916098
• Email: gprieur.kine[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Desaturation of Blood
• Exercise
• Pulmonary Rehabilitation

Intervention

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
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.

Locations

Country	Name	City	State
France	Groupe Hospitalier du Havre	Le Havre	Normandie

Sponsors (4)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre	Combret Yann, Machefert Margaux, Medrinal Clement

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in oxygen pulsed saturation	Difference in minimum saturation during both exercise, the measurement will be performed with a pulse oximeter (Spirodoc, MIR)	One week
Secondary	Difference in oxygen pulsed saturation	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
Secondary	Difference in peripheral muscle oxygenation	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
Secondary	Difference in respiratory rate	Difference in respiratory rate will be measured breath-by-breath using a portable spirometer (Spirodoc, MIR)	One week
Secondary	Difference in tidal volume	Difference in tidal volume will be measured breath-by-breath using a portable spirometer (Spirodoc, MIR)	One week
Secondary	Difference in inspiratory capacity	Difference in inspiratory capacity will be measured using a portable spirometer (Spirodoc, MIR)	One week
Secondary	Difference in Dyspnea	Dyspnea peak during exercise using the modified Borg scale 0-10, 0 no dyspnea, 10 maximal dyspnea	One week
Secondary	Difference in muscle discomfort	Muscle discomfort peak during exercise using the modified Borg scale 0-10, 0 no dyspnea, 10 maximal dyspnea	One week