Pulmonary DiseaseWIIRRNCT03793504

Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session

An observational study of Pulmonary Disease, run by University Hospital, Brest at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Disease
How many people: 20 participants
Where: 1 siteFrance
Study dates: 2 Jan 2019to 17 Jun 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients with pulmonary disease admitted in pulmonary rehabilitation unit of CHU Brest

Who may be able to join

patients with pulmonary disease

Who cannot join

exacerbation of the pulmonary disease
Weight >150Kg
Refusal to participate
People in pre and post surgical rehabilitation

Trial locations and contacts

1 site in 1 country.

France1 site

CH Morlaix
Morlaix, 29672

Other trials in France

About this study

Official title: 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

Conditions: Pulmonary Disease
Keywords: pulmonary rehabilitation, exercise, physical activity
Medical subject headings: Lung Diseases, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII
heart rate (pulse per minute) at the end of each session
Measured: one day

Secondary outcomes (4)

compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII
dyspnea (borg scale) at the end of each session
Measured: one day
compare lower limb muscle fatigue between a training session on cycle or treadmill and a training session on nintendo WII
lower limb muscle fatigue (borg scale) at the end of each session
Measured: one day
compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII
SpO2 at the end of each session
Measured: one day
Compare the felt pleasure between a training session on cycle or treadmill and a training session on nintendo WII
felt pleasure (likert scale) at the end of each session
Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 201917 Jun 2019

First posted4 Jan 2019
Study start2 Jan 2019
Primary completion17 Jun 2019
Study completion17 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by University Hospital, BrestThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03793504
Sponsor's protocol ID: WIIRR (29BRC18.0250)
Acronym: WIIRR
Status last verified: Jul 2020
First submitted: 2 Jan 2019
Last updated: 16 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03793504
Acronym / sponsor ID: WIIRR / WIIRR (29BRC18.0250)
Conditions: Pulmonary Disease
Keywords: pulmonary rehabilitation, exercise, physical activity
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University Hospital, BrestUniversity, hospital or other
Study start: 2 Jan 2019 (actual)
Primary completion: 17 Jun 2019 (actual)
Study completion: 17 Jun 2019 (actual)
First posted: 4 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients with pulmonary disease admitted in pulmonary rehabilitation unit of CHU Brest

Key inclusion criteria (1 listed)

patients with pulmonary disease

Key exclusion criteria (4 listed)

exacerbation of the pulmonary disease
Weight >150Kg
Refusal to participate
People in pre and post surgical rehabilitation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

4 secondary outcomes

compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII
Time frame: 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
compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.

Related trials for Pulmonary Disease

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc BEAUMONT, PhD principal investigator

CHRU de Brest

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03793504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.