Clinical trial NCT02920723: Follow-up of the Patients Included in the EXESAS Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Sleep Apnea, Obstructives
Keywords: Sleep Apnea Syndromes
Sleep Apnea, Obstructives
Training
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 79
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
timeFrame: 12 months
measure: Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.
timeFrame: 12 months
measure: Change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 12 months of follow-up in the 2 groups
timeFrame: 12 months
measure: Maximal aerobic capacity (VO2Max)
timeFrame: 12 months
measure: Population Physical Activity questionnaire (POPAQ)
timeFrame: 12 months
measure: Daily physical activity energy expenditure
timeFrame: 12 months
measure: Epworth sleepiness Scale
timeFrame: 12 months
measure: Pittsburgh questionnaire
timeFrame: 12 months
measure: Berlin questionnaire
timeFrame: 12 months
measure: Changes in blood pressure - Baroreflex
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Frederic ROCHE, MD - PhD
role: PRINCIPAL_INVESTIGATOR
References: