Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

Not Applicable

• Conditions: Obstructive Sleep Apnea; Physical Activity
• Interventions: Other: Telecoaching; Device: CPAP

• Registration Number: NCT03205878
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Study Start: 2017-07-01
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	CPAP	Patients will receive CPAP and telecoaching
Control group	CPAP	Patients will receive standard care, being CPAP treatment
Intervention group	Telecoaching	Patients will receive CPAP and telecoaching

Primary Outcome Measures

Name	Time	Method
Change in steps per day after 3 months	The change will be measured after 3 months	Steps per day as measured by a step counter

Secondary Outcome Measures

Name	Time	Method
Change in functional exercise capacity	3 months and 12 months compared with baseline	6-minute walking distance
Change in daytime sleepiness	3 months and 12 months compared with baseline	Epworth Sleepiness Scale
Change in body composition	3 months and 12 months compared with baseline	Bodystat 1500 measurement
Change in quality of life	3 months and 12 months compared with baseline	SF-36 questionnaire
Change in steps per day after 12 months	The change will be measured after 12 months	Steps per day as measured by a step counter
The proportion of patients with an increase > 1,000 steps per day	After 3 months (end of telecoaching) and after 12 months
Change in sleep quality	3 months and 12 months compared with baseline	Pittsburgh Sleep Quality Index
Change in endothelial function	3 months and 12 months compared with baseline	Endo-PAT 2000 measurement
The proportion of patients with > 7500 steps/day	Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months