Physical ActivityNCT03205878
Telecoaching to Improve Physical Activity in Patients With Obstructive Sleep Apnea
A study testing Telecoaching and CPAP in people with Physical Activity and Obstructive Sleep Apnea, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physical Activity, Obstructive Sleep Apnea
- What is being tested?
- Telecoaching and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure
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.
- Conditions
- Physical Activity, Obstructive Sleep Apnea
- Being tested
- Telecoaching, CPAP
- Medical subject headings
- Motor Activity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelecoachingOther
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.
CPAPDevice
Patients will receive CPAP according to standard care
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will receive standard care, being CPAP treatment Receives: Device: CPAP |
| Intervention group | Experimental | Patients will receive CPAP and telecoaching Receives: Other: Telecoaching; Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in steps per day after 3 months
Steps per day as measured by a step counter
Measured: The change will be measured after 3 months
Secondary outcomes (9)
The proportion of patients with an increase > 1,000 steps per day
Measured: After 3 months (end of telecoaching) and after 12 months
The proportion of patients with > 7500 steps/day
Measured: Before initiation of telecoaching (baseline), after 3 months (end of telecoaching) and after 12 months
Change in functional exercise capacity
6-minute walking distance
Measured: 3 months and 12 months compared with baseline
Change in daytime sleepiness
Epworth Sleepiness Scale
Measured: 3 months and 12 months compared with baseline
Change in sleep quality
Pittsburgh Sleep Quality Index
Measured: 3 months and 12 months compared with baseline
Change in endothelial function
Endo-PAT 2000 measurement
Measured: 3 months and 12 months compared with baseline
Change in body composition
Bodystat 1500 measurement
Measured: 3 months and 12 months compared with baseline
Change in quality of life
SF-36 questionnaire
Measured: 3 months and 12 months compared with baseline
Change in steps per day after 12 months
Steps per day as measured by a step counter
Measured: The change will be measured after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jul 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205878
- Sponsor's protocol ID
- S60283
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Activity in Obstructive Sleep Apnea Patients Treated With Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT03205878
- Acronym / sponsor ID
- S60283
- Conditions
- Physical Activity, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: CPAPPatients will receive standard care, being CPAP treatment |
| Intervention group | Experimental | Other: Telecoaching, Device: CPAPPatients will receive CPAP and telecoaching |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelecoachingPatients 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. | Other | Intervention group |
| CPAPPatients will receive CPAP according to standard care | Device | Control group, Intervention group |
Primary outcome
Change in steps per day after 3 months
Time frame: The change will be measured after 3 months
Steps per day as measured by a step counter
9 secondary outcomes
The proportion of patients with an increase > 1,000 steps per day
Time frame: After 3 months (end of telecoaching) and after 12 months
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
Change in functional exercise capacity
Time frame: 3 months and 12 months compared with baseline
Change in daytime sleepiness
Time frame: 3 months and 12 months compared with baseline
Change in sleep quality
Time frame: 3 months and 12 months compared with baseline
Change in endothelial function
Time frame: 3 months and 12 months compared with baseline
Change in body composition
Time frame: 3 months and 12 months compared with baseline
Change in quality of life
Time frame: 3 months and 12 months compared with baseline
Change in steps per day after 12 months
Time frame: The change will be measured after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telecoaching and CPAP in people with Physical Activity and Obstructive Sleep Apnea, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in steps per day after 3 months (time frame: The change will be measured after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.