Sport as a Treatment in Chronic Diseases and Healthcare Sustainability (S4H)

February 21, 2018 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • France
      • La Tronche, France, 38700
        • University Hospital, Grenoble

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

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rehabilitation medical center

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.
Behavioral: Physical activity

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.
Other Names:
  • Programs of sport "prescription"
Experimental: Private sport club

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.
Behavioral: Physical activity

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.
Other Names:
  • Programs of sport "prescription"
Experimental: Sport association

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.
Behavioral: Physical activity

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.
Other Names:
  • Programs of sport "prescription"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at the end of the 3-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effect of the different programs of sport "prescription" on patient motivation
Time Frame: over a 3-month period
The evaluation of the effect of the different programs of sport "prescription" on patient motivation will be assessed by a motivational questionnaire.
over a 3-month period
Cost effectiveness analysis of the different programs of sport "prescription"
Time Frame: over a 3-month period.
Monthly cost of the subscription in the sport association, private sport club and rehabilitation medical center will be collected.
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
Monthly self measurement of weight and BP at home, recorded in the application
each month, over 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Louis Pépin, MD, PhD, University Hospital of Grenoble, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 5, 2017

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.047
  • 2017-A00467-46 (Other Identifier: IdRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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