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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructives

Treatments: Other: Control; Other: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02920723

2016-A00859-42 (Other Identifier)

1608082

Details and patient eligibility

About

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.

Full 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

Enrollment: 79 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Training

Experimental group

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.

Treatment:

Other: Training

Control

Other group

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

Treatment:

Other: Control