Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
open, proof of concept study in overweight or moderate obese OSA patients,
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Consenting patient based around Grenoble France
- •Be legally able to give consent
- •Person affiliated to social security
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)(each month, over 3 months)
- 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.)