Follow-up of the Patients Included in the EXESAS Study (FOLLOW_EXESAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructives
• Intervention / Treatment: Other: Control; Other: Training

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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training; 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.	Other: Training; Other Names: NeuroGyV program
Other: Control; 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	Other: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.		12 months
Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.		12 months
Change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 12 months of follow-up in the 2 groups		12 months
Maximal aerobic capacity (VO2Max)	Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups	12 months
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	12 months
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	12 months
Epworth sleepiness Scale	Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups	12 months
Pittsburgh questionnaire	Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups	12 months
Berlin questionnaire	Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups	12 months
Changes in blood pressure - Baroreflex	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Frederic ROCHE, MD - PhD, CHU de Saint-Etienne

Publications and helpful links

Helpful Links

• Website of the FFEPGV (in french)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 21, 2018
• Study Completion (Actual): August 21, 2018

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Training; Sleep Apnea Syndromes; Sleep Apnea, Obstructives
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 1608082; 2016-A00859-42 (Other Identifier: ANSM)

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