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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Training (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
Intervention: Control (Other)
Outcomes
Primary Outcomes
the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups
Time Frame: 12 months
Apnea-Hypopnea Index (AHI)
Secondary Outcomes
- 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)
- Berlin questionnaire(12 months)
- Daily physical activity energy expenditure(12 months)
- Pittsburgh questionnaire(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)
- Maximal aerobic capacity (VO2Max)(12 months)
- Epworth sleepiness Scale(12 months)
- Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.(12 months)
- Population Physical Activity questionnaire (POPAQ)(12 months)
- Changes in blood pressure - Baroreflex(12 months)