Obstructive Sleep ApneaS4HNCT03087318
Sport as a Treatment in Chronic Diseases and Healthcare Sustainability
A study testing Physical activity in people with Obstructive Sleep Apnea and Overweight and Obesity, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Overweight and Obesity
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2017to 15 Feb 2018
- Phase
- Interventional
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 y ≤ age ≤ 70 y
- 27 < BMI < 32
- Weight < 120 kg
- Apneic patient (Apnea-hypopnea index > 15/h) treated or not by CPAP (continuous positive airway pressure )
- Be able to practice sport (according to a Cardiologist decision)
- Be able to use the personal health monitoring devices jointly to a personal Touch phone
Show all 9Show fewer
- Consenting patient based around Grenoble France
- Be legally able to give consent
- Person affiliated to social security
Who cannot join
- Being unable to understand, follow objectives and methods due to cognition or language problems
- Pregnant women, feeding and parturient
- Physical activity score > 9, calculated by Baecke's questionnaire (Annex 1)
- Subject under administrative or judicial control, person who are protected under the act.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health
Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.
Read the detailed description
With automation equipment and the comfort, it has brought, less natural physical activities are required and people do not take the time to do some. Therefore, obesity, associated with obstructive sleep apnea (OSA) up to 60% of cases, has become a heavy burden on the society and the healthcare system, besides the fact that it often involves cardiovascular diseases. Assistance is urgently needed and the investigators want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. In order to do that, the investigators will integrate sport in the patient pathway and support in his/her involvement. This last point means that a link between medical and sport specialists should be established, and this is missing today.
This study aims to reconcile the world of patients and the world of sport, by offering a trajectory and an organization that help patients to initiate physical activity.
The investigators plan to measure the physical activity of overweight or moderate obese, apneic patients in the different programs at the end of the 3-month period by physical activity objective parameters: number of steps/day.
The secondary objectives of this study are to:
- Evaluate the effect of the different programs of sport "prescription" on patient motivation, over a 3-month period by a motivational questionnaire.
- Analyze the cost effectiveness of the different programs of sport "prescription" over a 3-month period.
- Evaluate the effect of the different programs of sport "prescription" on weight and blood pressure (BP), assessed by home self-measurements each month, over a 3-month period and recorded in the application.
- Conditions
- Obstructive Sleep Apnea, Overweight and Obesity
- Being tested
- Physical activity
- Keywords
- Obstructive sleep apnea (OSA), Overweight and moderate obesity, Sport prescription, Physical activity
- Medical subject headings
- Sleep Apnea, Obstructive, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Also called Programs of sport "prescription"
Physical activity:
- 3 sessions / week at least
- at least during 30 minutes each session
- at least at 50% of the maximal heart rate measured during the exercise stress testing (from the screening)
- during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation medical center | Experimental | Physical activity:
* 3 sessions / week at least
* at least during 30 minutes each session
* at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening)
* during 3 months. Receives: Behavioral: Physical activity |
| Private sport club | Experimental | Physical activity:
* 3 sessions / week at least
* at least during 30 minutes each session
* at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening)
* during 3 months. Receives: Behavioral: Physical activity |
| Sport association | Experimental | Physical activity:
* 3 sessions / week at least
* at least during 30 minutes each session
* at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening)
* during 3 months. Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The physical activity of overweight or moderate obese OSA patients in the different programs will be estimated by physical activity objective parameters: number of steps/day.
The physical activity of overweight or moderate obese OSA patients in the different programs during the 3-month period will be estimated by physical activity objective parameters: heart rate, physical activity type, motion cadence (number of steps/day), energy expenditure, and sleep stage (measured at the end, by an actigraph integrated in the watch).
Measured: at the end of the 3-month period
Secondary outcomes (3)
Evaluation of the effect of the different programs of sport "prescription" on patient motivation
The evaluation of the effect of the different programs of sport "prescription" on patient motivation will be assessed by a motivational questionnaire.
Measured: over a 3-month period
Cost effectiveness analysis of the different programs of sport "prescription"
Monthly cost of the subscription in the sport association, private sport club and rehabilitation medical center will be collected.
Measured: over a 3-month period.
Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)
Monthly self measurement of weight and BP at home, recorded in the application
Measured: each month, over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start5 Apr 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open, proof of concept study in overweight or moderate obese OSA patients, comparing 3 different programs of sport "prescription": patient's referred to a rehabilitation medical center, to a private sport club or to a sport association.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, MD, PhD, Principal investigator, University Hospital of Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087318
- Sponsor's protocol ID
- 38RC17.047
- Other IDs
- 2017-A00467-46
- Acronym
- S4H
- Status last verified
- Feb 2018
- First submitted
- 16 Mar 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156.
PubMed 28117479Borjesson M, Urhausen A, Kouidi E, Dugmore D, Sharma S, Halle M, Heidbuchel H, Bjornstad HH, Gielen S, Mezzani A, Corrado D, Pelliccia A, Vanhees L. Cardiovascular evaluation of middle-aged/ senior individuals engaged in leisure-time sport activities: position stand from the sections of exercise physiology and sports cardiology of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):446-58. doi: 10.1097/HJR.0b013e32833bo969.
PubMed 21450560
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health
- ClinicalTrials.gov ID
- NCT03087318
- Acronym / sponsor ID
- S4H / 38RC17.047
- Conditions
- Obstructive Sleep Apnea, Overweight and Obesity
- Keywords
- Obstructive sleep apnea (OSA), Overweight and moderate obesity, Sport prescription, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 22 Mar 2017 (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.
Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.
Detailed description
With automation equipment and the comfort, it has brought, less natural physical activities are required and people do not take the time to do some. Therefore, obesity, associated with obstructive sleep apnea (OSA) up to 60% of cases, has become a heavy burden on the society and the healthcare system, besides the fact that it often involves cardiovascular diseases. Assistance is urgently needed and the investigators want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. In order to do that, the investigators will integrate sport in the patient pathway and support in his/her involvement. This last point means that a link between medical and sport specialists should be established, and this is missing today.
This study aims to reconcile the world of patients and the world of sport, by offering a trajectory and an organization that help patients to initiate physical activity.
The investigators plan to measure the physical activity of overweight or moderate obese, apneic patients in the different programs at the end of the 3-month period by physical activity objective parameters: number of steps/day.
The secondary objectives of this study are to:
- Evaluate the effect of the different programs of sport "prescription" on patient motivation, over a 3-month period by a motivational questionnaire.
- Analyze the cost effectiveness of the different programs of sport "prescription" over a 3-month period.
- Evaluate the effect of the different programs of sport "prescription" on weight and blood pressure (BP), assessed by home self-measurements each month, over a 3-month period and recorded in the application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, open, proof of concept study in overweight or moderate obese OSA patients, comparing 3 different programs of sport "prescription": patient's referred to a rehabilitation medical center, to a private sport club or to a sport association.
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation medical center | Experimental | Behavioral: Physical activityPhysical activity: * 3 sessions / week at least * at least during 30 minutes each session * at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening) * during 3 months. |
| Private sport club | Experimental | Behavioral: Physical activityPhysical activity: * 3 sessions / week at least * at least during 30 minutes each session * at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening) * during 3 months. |
| Sport association | Experimental | Behavioral: Physical activityPhysical activity: * 3 sessions / week at least * at least during 30 minutes each session * at least at 50% of the maximal HR(heart rate) measured during the exercise stress testing (from the screening) * during 3 months. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 25 y ≤ age ≤ 70 y
- 27 < BMI < 32
- Weight < 120 kg
- Apneic patient (Apnea-hypopnea index > 15/h) treated or not by CPAP (continuous positive airway pressure )
- Be able to practice sport (according to a Cardiologist decision)
Key exclusion criteria (4 listed)
- Being unable to understand, follow objectives and methods due to cognition or language problems
- Pregnant women, feeding and parturient
- Physical activity score > 9, calculated by Baecke's questionnaire (Annex 1)
- Subject under administrative or judicial control, person who are protected under the act.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: Programs of sport "prescription"Physical activity: * 3 sessions / week at least * at least during 30 minutes each session * at least at 50% of the maximal heart rate measured during the exercise stress testing (from the screening) * during 3 months. | Behavioural | Private sport club, Rehabilitation medical center, Sport association |
Primary outcome
The physical activity of overweight or moderate obese OSA patients in the different programs will be estimated by physical activity objective parameters: number of steps/day.
Time frame: at the end of the 3-month period
The physical activity of overweight or moderate obese OSA patients in the different programs during the 3-month period will be estimated by physical activity objective parameters: heart rate, physical activity type, motion cadence (number of steps/day), energy expenditure, and sleep stage (measured at the end, by an actigraph integrated in the watch).
3 secondary outcomes
Evaluation of the effect of the different programs of sport "prescription" on patient motivation
Time frame: over a 3-month period
Cost effectiveness analysis of the different programs of sport "prescription"
Time frame: over a 3-month period.
Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)
Time frame: each month, over 3 months
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 23 Feb 2018.
- Results publication: PubMed 28117479Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156.
- Results publication: PubMed 21450560Borjesson M, Urhausen A, Kouidi E, Dugmore D, Sharma S, Halle M, Heidbuchel H, Bjornstad HH, Gielen S, Mezzani A, Corrado D, Pelliccia A, Vanhees L. Cardiovascular evaluation of middle-aged/ senior individuals engaged in leisure-time sport activities: position stand from the sections of exercise physiology and sports cardiology of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):446-58. doi: 10.1097/HJR.0b013e32833bo969.
- Individual participant dataSharing planned: No
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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.
Jean-Louis Pépin, MD, PhD principal investigator
University Hospital of Grenoble, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Obstructive Sleep Apnea and Overweight and Obesity, run by University Hospital, Grenoble 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 9 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 23 Feb 2018. 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?
The physical activity of overweight or moderate obese OSA patients in the different programs will be estimated by physical activity objective parameters: number of steps/day. (time frame: at the end of the 3-month period). 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 NCT03087318, which also lists 2 linked publications.
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 23 Feb 2018.