- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03793504
Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session (WIIRR)
July 15, 2020 updated by: University Hospital, Brest
Cardio-Respiratory Response of an Exercise Training Session With Ergocycle or Treadmill Compared to an Adapted Physical Activity Session on a Wii, in Patients With Pulmonary Disease
the aim of this study is to show that training session with nintendo WII requires the same cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used in pulmonary rehabilitation program.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Morlaix, France, 29672
- CH Morlaix
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with pulmonary disease admitted in pulmonary rehabilitation unit of CHU Brest
Description
Inclusion Criteria:
- patients with pulmonary disease
Exclusion Criteria:
- exacerbation of the pulmonary disease
- Weight >150Kg
- Refusal to participate
- People in pre and post surgical rehabilitation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII
Time Frame: one day
|
heart rate (pulse per minute) at the end of each session
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII
Time Frame: one day
|
dyspnea (borg scale) at the end of each session
|
one day
|
compare lower limb muscle fatigue between a training session on cycle or treadmill and a training session on nintendo WII
Time Frame: one day
|
lower limb muscle fatigue (borg scale) at the end of each session
|
one day
|
compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII
Time Frame: one day
|
SpO2 at the end of each session
|
one day
|
Compare the felt pleasure between a training session on cycle or treadmill and a training session on nintendo WII
Time Frame: one day
|
felt pleasure (likert scale) at the end of each session
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc BEAUMONT, PhD, CHRU de Brest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2019
Primary Completion (Actual)
June 17, 2019
Study Completion (Actual)
June 17, 2019
Study Registration Dates
First Submitted
January 2, 2019
First Submitted That Met QC Criteria
January 3, 2019
First Posted (Actual)
January 4, 2019
Study Record Updates
Last Update Posted (Actual)
July 16, 2020
Last Update Submitted That Met QC Criteria
July 15, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WIIRR (29BRC18.0250)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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