- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363447
Effects of Different Telerehabilitation Methods In Patients With Hypertension (TELE-HT) (TELE-HT)
The Role of Supervision: Effects of Different Telerehabilitation Methods In Patients With Hypertension
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Hacettepe University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of systemic hypertension.
- Age between 18 and 65 years.
- Access to the internet.
- Ownership of a mobile device suitable for telerehabilitation participation.
Exclusion Criteria:
- Presence of comorbid cardiovascular and/or pulmonary diseases.
- Unstable metabolic conditions.
- History of cerebrovascular and/or cardiovascular disease events within the past three months.
- Mental disorders that interfere with exercise cooperation.
- Balance or fall-related problems.
- Orthopedic or neurological conditions that compromise the safety of exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Synchronous Telerehabilitation (STR)
8-week aerobic-based calisthenics (3 sessions/week, 45 min/session) under real-time physiotherapist supervision via videoconferencing.
|
An 8-week aerobic-based calisthenics program consisting of 24 sessions (3 sessions/week, 45 minutes each). Exercises are performed in real-time under the live supervision of a physiotherapist via videoconferencing (WhatsApp). Intensity is maintained at 70-85% of age-predicted maximum heart rate, monitored in real-time using a wearable smartband. Exercises include high knees, knee-to-elbow, side jacks, and other calisthenics.
Other Names:
|
|
Active Comparator: Asynchronous Telerehabilitation (ATR)
8-week aerobic-based calisthenics (3 sessions/week, 45 min/session) delivered via pre-recorded videos and exercise diaries.
|
The same 8-week aerobic-based calisthenics program (24 sessions, 3 sessions/week) as the STR group. Exercises are performed independently by participants using pre-recorded video content. Participants maintain an exercise diary to record heart rate and blood pressure levels, which are reviewed weekly by a physiotherapist. Exercise intensity is adjusted weekly based on data from the participant's wearable smartband.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Capacity
Time Frame: Before and after the training (0 and 8th Week)
|
Change in Functional Exercise Capacity (6-Minute Stepper Test); The number of steps completed within six minutes using a stepper device.
Higher step counts indicate better functional capacity.
|
Before and after the training (0 and 8th Week)
|
|
Exercise Capacity
Time Frame: Before and after the training (0 and 8th weeks)
|
Predicted maximal oxygen uptake; Calculated from the duration of the maximal stress test (Bruce protocol) using validated formulas for men and women.
It represents maximal aerobic capacity in mL/kg/min.
|
Before and after the training (0 and 8th weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure Levels
Time Frame: Before and after the training (0 and 8th weeks)
|
Ambulatory Blood Pressure Monitoring (ABPM) Parameters; Mean 24-hour, daytime, and nighttime systolic (SBP) and diastolic blood pressure (DBP) levels measured in mmHg.
|
Before and after the training (0 and 8th weeks)
|
|
Cardiac Functions
Time Frame: Before and after the training (0 and 8th weeks)
|
Systolic functions assessed with echocardiography expressed by ejection fraction (EF, %) and diastolic functions E and A waves measured via transthoracic echocardiography (TTE).
E wave represents early diastolic velocity, and A wave represents late diastolic velocity.
|
Before and after the training (0 and 8th weeks)
|
|
Self-Care Levels
Time Frame: Before and after the training (0 and 8th weeks)
|
Self-Care of Hypertension Inventory (SC-HI V3.0) Score; A 23-item Likert-type scale with maintenance, monitoring, and management subscales.
Each subscale is scored from 0 to 100, where higher scores indicate better self-care.
|
Before and after the training (0 and 8th weeks)
|
|
Postural Stability and Upper Extremity Function
Time Frame: Before and after the training (0 and 8th weeks)
|
Plank test duration (in seconds)
|
Before and after the training (0 and 8th weeks)
|
|
Lower Extremity Muscle Function
Time Frame: Before and after the trainining (0 and 8th weeks)
|
Numbers of Squat
|
Before and after the trainining (0 and 8th weeks)
|
|
Objective Physical Activity Level
Time Frame: Before and after the training (0 and 8th weeks)
|
Average daily and weekly total step counts and weekly exercise duration were recorded using a wearable smart wristband
|
Before and after the training (0 and 8th weeks)
|
|
Subjective Physical Activity Levels
Time Frame: Before and after the training (0 and 8th weeks)
|
Self-reported PA levels according to the International Physical Activity Questionnaire (IPAQ) score.
IPAQ includes vigorous, moderate and walking activities during the last seven days and higher scores reflect higher physical activity levels.
|
Before and after the training (0 and 8th weeks)
|
|
Body Mass Index
Time Frame: Before and after the training (0 and 8th weeks)
|
Body weight/ (height*height) (kg/m2)
|
Before and after the training (0 and 8th weeks)
|
|
Body Composition-Anthropometric Measure
Time Frame: Before and after the training (0 and 8th weeks)
|
Weight to height ratio (kg/cm)
|
Before and after the training (0 and 8th weeks)
|
|
Body Fat Percantage
Time Frame: Before and after the training (0 and 8th weeks)
|
body fat percentage (%) assessed by bioelectrical impedance analysis
|
Before and after the training (0 and 8th weeks)
|
|
Fat Free Mass
Time Frame: Before and after the training (0 and 8th weeks)
|
Fat Free Mass assessed by bioelectrical impedance analysis
|
Before and after the training (0 and 8th weeks)
|
|
Lipid Profile
Time Frame: Before and after the training (0 and 8th weeks)
|
Measured via blood samples including low-density lipoprotein (LDL) and high-density lipoprotein (HDL) levels in mg/dL.
|
Before and after the training (0 and 8th weeks)
|
|
Cardiovascular Disease (CVD) Risk Profile
Time Frame: Before and after the training (0 and 8the weeks)
|
Cardiovascular Disease (CVD) Risk Profile; Estimated using the SCORE-TR risk chart, which calculates the 10-year risk of fatal cardiovascular disease based on age, gender, smoking status, systolic blood pressure, and total cholesterol.
|
Before and after the training (0 and 8the weeks)
|
|
Waist Circumference
Time Frame: Before and after the training (0 and 8th weeks)
|
Waist Circumference in cm
|
Before and after the training (0 and 8th weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-KAEK-189_2024.02.23_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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