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Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift

Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift in Patients Who Can't Use CPAP or MAD

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04623463
Acronym
AP-FLUID
Enrollment
62
Registered
2020-11-10
Start date
2020-10-20
Completion date
2026-10-20
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

Obstructive sleep apnea (OSA) is characterized by complete or partial upper-airway collapse during sleep associated with sleepiness. OSA causes severe impairments in quality of life (sleepiness, tiredness, concentration difficulties). Moreover, OSA has adverse consequences on the cardiovascular system by causing intermittent hypoxia, increased sympathetic nervous system activation and vascular endothelial dysfunction. Continuous Positive Airway Pressure (CPAP) and mandibular advanced devices (MAD) remain the two first-line therapies for OSA. However, not all patients are eligible for these treatments or are not able to follow for a lifelong therapy and therefore do not use it consistently. A recent meta-analysis has confirmed that regular physical activity reduces OSA by approximately 28% (Mendelson et al. 2018). However, an important inter-individual variability exists and no study to date has identified characteristics of patients who respond to these interventions. The aim of this Prospective study, single-site, non-randomized 4-week trial is to evaluate the impact of a 4-week physical activity intervention on the apnea-hypopnea index (AHI) in OSA patients based on their baseline fluid shift level. Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.

Interventions

BEHAVIORALPhysical activity intervention

Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.

Sponsors

HP2 Laboratory
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* • Patient aged 18 to 80 years old * Patient with OSA (AHI ≥ 15 events/hr) * Patient not receiving any treatment for their OSA * Patient able to provide written informed consent * Patient able to participate in regular physical activity (no medical contraindication to exercise)

Exclusion criteria

* • Pregnancy * Person deprived of liberty or subject to a legal protection measure * Patient presenting a condition that can influence the results. (According to the investigator's judgment, i.e. heart failure, venous insufficiency). * Vulnerable person or legally protected adult. * Patients already included in another interventional study * BMI \> 30 kg/m² * Patient taking diuretics

Design outcomes

Primary

MeasureTime frameDescription
Apnea-Hypopnea indexBaseline-4weeksMeasured during polysomnography

Secondary

MeasureTime frameDescription
Subjective sleepiness as measured by the Epworth Sleepiness ScoreBaseline-4weeksMeasured with the Epworth Sleepiness Score Questionnaire
Overnight change in leg fluid volumeBaseline-4weeksMeasured using bio-electrical impedance
Quality of life assessed by the SF-36 questionnaireBaseline-4weeksMeasured using the SF-36 questionnaire

Countries

France

Contacts

Primary ContactMonique MENDELSON, phD
mmendelson@chu-grenoble.fr04 76 76 72 26

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026