Sport as a Treatment in Chronic Diseases and Healthcare Sustainability
S4H
2 other identifiers
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
1 active site
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
March 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedStudy Start
First participant enrolled
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2018
CompletedFebruary 23, 2018
February 1, 2018
11 months
March 16, 2017
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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
over a 3-month period
Cost effectiveness analysis of the different programs of sport "prescription"
over a 3-month period.
Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)
each month, over 3 months
Study Arms (3)
Rehabilitation medical center
EXPERIMENTALPhysical 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
EXPERIMENTALPhysical 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
EXPERIMENTALPhysical 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- y ≤ age ≤ 70 y
- \< 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
- Consenting patient based around Grenoble France
- Be legally able to give consent
- Person affiliated to social security
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Grenoble
La Tronche, 38700, France
Related Publications (2)
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.
PMID: 28117479RESULTBorjesson 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.
PMID: 21450560RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Louis Pépin, MD, PhD
University Hospital of Grenoble, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- open, proof of concept study in overweight or moderate obese OSA patients,
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2017
First Posted
March 22, 2017
Study Start
April 5, 2017
Primary Completion
February 15, 2018
Study Completion
February 15, 2018
Last Updated
February 23, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share