NCT05825638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 10, 2023

Last Update Submit

January 18, 2026

Conditions

Keywords

COPDPulmonary rehabilitationInterval training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Difference in oxygen pulsed saturation

    One week

  • Difference in peripheral muscle oxygenation

    One week

  • Difference in respiratory rate

    One week

  • Difference in tidal volume

    One week

  • Difference in inspiratory capacity

    One week

  • +2 more secondary outcomes

Study Arms (2)

Continuous training session

Other: Continuous training session

Interval Training session

Other: Interval training session

Interventions

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.

Interval 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

Continuous training session

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COPD who meet the inclusion criteria will be offered to participate in this study during a pulmonary rehabilitation programme which will take place in the pneumology rehabilitation department of the Le Havre Hospital. If the patient wishes to participate in the study, he/she will be given an information note containing a declaration of non-opposition which he/she will have to complete and sign.

You may qualify if:

  • a diagnosis of COPD
  • participating in a pulmonary rehabilitation programme
  • with an exercise-induced desaturation less than 90%
  • no oxygen supplementation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier du Havre

Le Havre, Normandy, 76290, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Guillaume Prieur, PT, PhD

    Groupe Hospitalier du Havre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2023

First Posted

April 24, 2023

Study Start

January 10, 2023

Primary Completion

September 30, 2025

Study Completion

October 10, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

deidentified participtant data

Shared Documents
SAP, CSR
Time Frame
after publication
Access Criteria
the request shall be sent to Guillaume Prieur (gprieur.kine@gmail.com)

Locations