Follow-up of the Patients Included in the EXESAS Study (FOLLOW_EXESAS)
Primary Purpose
Sleep Apnea Syndromes, Sleep Apnea, Obstructives
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Sleep Apnea Syndromes focused on measuring Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training
Eligibility Criteria
Inclusion Criteria:
- Included in the previous EXESAS study
- Signature of consent
Exclusion Criteria:
- Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
- Daytime sleepiness (ESS score > 10)
- Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
- Patients with Parkinson's disease
- AHI > 30
Sites / Locations
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Training
Control
Arm Description
For the patients who were allocated in the control group in the EXESAS study. In this group, patients will perform 3 sessions of one hour per week of the "NeuroGyV" training program. It is a physical activity program with one session of Nordic walking, one session of "aquagym" and one session of gymnastic. Program lasts 9 months.
For the patients who were allocated in the training group in the EXESAS study. In this group, patients will receive only diets and physical activity counselling
Outcomes
Primary Outcome Measures
the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups
Apnea-Hypopnea Index (AHI)
Secondary Outcome Measures
Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
Change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 12 months of follow-up in the 2 groups
Maximal aerobic capacity (VO2Max)
Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups
Population Physical Activity questionnaire (POPAQ)
Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups
Daily physical activity energy expenditure
Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups
Epworth sleepiness Scale
Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups
Pittsburgh questionnaire
Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups
Berlin questionnaire
Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups
Changes in blood pressure - Baroreflex
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Full Information
NCT ID
NCT02920723
First Posted
September 29, 2016
Last Updated
November 2, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02920723
Brief Title
Follow-up of the Patients Included in the EXESAS Study
Acronym
FOLLOW_EXESAS
Official Title
Follow-up of the Patients Included in the EXESAS Study : Analysis of the Profit of the Physical Activity for the Control Group and of the Preservation of a Regular Physical Activity for the Group Initially Trained
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.
Detailed Description
In the previous EXESAS study (NCT02463890) the investigators compare evolution of Apnea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.
The first partial observations of the study EXESAS seem encouraging in the term of 3 months of training. However, in the longer term, there is not a coverage in the treatment of the moderate Sleep Apnea: Obstructive Syndrome (SAOS). Thus they can logically expect that the possible therapeutic effect of the exercise is not maintained in the long term after the stop of the training.
This nex study suggests studying the profit of the exercise on sleep apneas for the patients who were initially in the control group in the EXESAS study and to observe if the preservation of a regular physical activity for the group which was trained in EXESAS study is associated with a preservation of the AHI after the additional year of follow-up without additional intervention
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Apnea, Obstructives
Keywords
Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
For the patients who were allocated in the control group in the EXESAS study. In this group, patients will perform 3 sessions of one hour per week of the "NeuroGyV" training program. It is a physical activity program with one session of Nordic walking, one session of "aquagym" and one session of gymnastic. Program lasts 9 months.
Arm Title
Control
Arm Type
Other
Arm Description
For the patients who were allocated in the training group in the EXESAS study. In this group, patients will receive only diets and physical activity counselling
Intervention Type
Other
Intervention Name(s)
Training
Other Intervention Name(s)
NeuroGyV program
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups
Description
Apnea-Hypopnea Index (AHI)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
Time Frame
12 months
Title
Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
Time Frame
12 months
Title
Change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 12 months of follow-up in the 2 groups
Time Frame
12 months
Title
Maximal aerobic capacity (VO2Max)
Description
Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups
Time Frame
12 months
Title
Population Physical Activity questionnaire (POPAQ)
Description
Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups
Time Frame
12 months
Title
Daily physical activity energy expenditure
Description
Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups
Time Frame
12 months
Title
Epworth sleepiness Scale
Description
Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups
Time Frame
12 months
Title
Pittsburgh questionnaire
Description
Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups
Time Frame
12 months
Title
Berlin questionnaire
Description
Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups
Time Frame
12 months
Title
Changes in blood pressure - Baroreflex
Description
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Included in the previous EXESAS study
Signature of consent
Exclusion Criteria:
Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
Daytime sleepiness (ESS score > 10)
Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
Patients with Parkinson's disease
AHI > 30
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic ROCHE, MD - PhD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.sport-sante.fr/accueil/
Description
Website of the FFEPGV (in french)
Learn more about this trial
Follow-up of the Patients Included in the EXESAS Study
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