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Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

Primary Purpose

Physical Activity, Obstructive Sleep Apnea

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Telecoaching

CPAP

About this trial

This is an interventional treatment trial for Physical Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

Patients will receive standard care, being CPAP treatment

Patients will receive CPAP and telecoaching

Outcomes

Primary Outcome Measures

Change in steps per day after 3 months

Steps per day as measured by a step counter

Secondary Outcome Measures

The proportion of patients with an increase > 1,000 steps per day

The proportion of patients with > 7500 steps/day

Change in functional exercise capacity

6-minute walking distance

Change in daytime sleepiness

Epworth Sleepiness Scale

Change in sleep quality

Pittsburgh Sleep Quality Index

Change in endothelial function

Endo-PAT 2000 measurement

Change in body composition

Bodystat 1500 measurement

Change in quality of life

SF-36 questionnaire

Change in steps per day after 12 months

Steps per day as measured by a step counter

Full Information

NCT ID

NCT03205878

First Posted

June 28, 2017

Last Updated

June 29, 2017

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT03205878

Brief Title

Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Physical Activity, Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Patients will receive standard care, being CPAP treatment

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Patients will receive CPAP and telecoaching

Intervention Type

Other

Intervention Name(s)

Telecoaching

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

CPAP

Intervention Description

Patients will receive CPAP according to standard care

Primary Outcome Measure Information:

Title

Change in steps per day after 3 months

Description

Steps per day as measured by a step counter

Time Frame

The change will be measured after 3 months

Secondary Outcome Measure Information:

Title

The proportion of patients with an increase > 1,000 steps per day

Time Frame

After 3 months (end of telecoaching) and after 12 months

Title

The proportion of patients with > 7500 steps/day

Time Frame

Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months

Title

Change in functional exercise capacity

Description

6-minute walking distance

Time Frame