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Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03205878
Enrollment
102
Registered
2017-07-02
Start date
2017-07-01
Completion date
2019-12-31
Last updated
2017-07-02

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

Conditions

Obstructive Sleep Apnea, Physical Activity

Brief summary

Patients with obstructive sleep apnea (OSA) are less physically active than healthy controls. First choice of treatment for OSA is continuous positive airway pressure (CPAP) therapy with an improvement in oxygen saturation and sleep. No improvement on physical activity has been shown. The current study would randomize patients in a standard care group (CPAP) and an intervention group (CPAP + telecoaching). Telecoaching will be performed for 3 months, with physical activity assessment before, after 3 months and 12 years.

Interventions

Patients in the intervention arm will receive a step counter and a cell phone with an app on which the amount of steps are daily sent to. Initial targets on steps per day will be discussed with the patient after an activity monitoring before the telecoaching procedure. Dependent whether the patient reaches his/her proposed goal each week, new goals are set.

DEVICECPAP

Patients will receive CPAP according to standard care

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* AHI \> 15 events/hour, measured by polysomnography * \< 7,500 steps per day * Willing to start CPAP treatment * Age between 18 and 65 years * Signing the written informed consent

Exclusion criteria

* Patients with neuromuscular diseases * Patients with chronic obstructive pulmonary disease and interstitial lung disease * Patients with cardiac failure and ischemic heart failure * Patients with comorbidities which could interfere with a normal biomechanical gait pattern and the possibility of increasing physical activity * Patients with mental disability making it impossible to understand the study protocol and the use of electronic devices.

Design outcomes

Primary

MeasureTime frameDescription
Change in steps per day after 3 monthsThe change will be measured after 3 monthsSteps per day as measured by a step counter

Secondary

MeasureTime frameDescription
The proportion of patients with an increase > 1,000 steps per dayAfter 3 months (end of telecoaching) and after 12 months
The proportion of patients with > 7500 steps/dayBefore initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months
Change in functional exercise capacity3 months and 12 months compared with baseline6-minute walking distance
Change in daytime sleepiness3 months and 12 months compared with baselineEpworth Sleepiness Scale
Change in endothelial function3 months and 12 months compared with baselineEndo-PAT 2000 measurement
Change in body composition3 months and 12 months compared with baselineBodystat 1500 measurement
Change in quality of life3 months and 12 months compared with baselineSF-36 questionnaire
Change in steps per day after 12 monthsThe change will be measured after 12 monthsSteps per day as measured by a step counter
Change in sleep quality3 months and 12 months compared with baselinePittsburgh Sleep Quality Index

Outcome results

None listed

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