- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04862754
Effect of Interval Training on Arterial Stiffness in Women With Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 17452
- Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- physically inactive
- BMI 30-40
- Stage 1 and 2 hypertension
- Elevated BP as systolic BP ≥130 mm Hg and/or diastolic BP ≥85 mm Hg measured at the brachial artery.
Exclusion Criteria:
- Medications known to affect weight or appetite
- Any disease associated with exercise intolerance.
- Women were taking hormone replacement therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interval training
Aerobic interval training.
It consisted of a modified interval cycle ergometer training program (3 days a week for 8 weeks).
AIT consisted of 8 min warm up, followed by four times of 4-min intervals with HR at 80% of submaximal predetermined HR, with active phases of 3 min of cycling at 60% of submaximal predetermined HR.
The exercise session was terminated by 5 min cool down
|
interval training exercise
|
|
No Intervention: medical treatment
hypertensive medication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central arterial stiffness measurements (Pulse Wave Velocity [PWV], augmentation index )
Time Frame: two months
|
Pulse wave analysis (PWA) of the women in the two groups: pre and post treatment for pulse wave velocity (PWV) and augmentation index(AIx) Pulse Wave Velocity [PWV], augmentation index (AIx @75HR) and resting heart rate were measured using analysis equipment which called Non-invasive blood pressure measurement system using "Mobil-O-Graph 24h PWA " with Hypertension Management Software Client Server (HMS-CS 4.3). PWA was performed using an oscillometric Mobil-O-Graph R 24 h PWA Monitor device (I.E.M GmbH, Germany) with integrated ARCSolver® software |
two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood lipid profile
Time Frame: two months
|
blood analysis will be used to measure lipid profile (high and low-density lipoprotein, cholesterol, triglyceride)
|
two months
|
|
interleukin 6
Time Frame: two months
|
blood analysis will be used to measure interleukin 6
|
two months
|
|
blood pressure (systolic and diastolic)
Time Frame: two months
|
resting Blood pressure was monitored from the right arm using an automated digital electronic BP monitor (Omron digital BP monitor, Model 11 EM 403c; Tokyo Japan).
|
two months
|
Collaborators and Investigators
Sponsor
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
- P.T REC/012/003094.
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.
Clinical Trials on Arterial Stiffness
-
Chinese University of Hong KongNot yet recruitingArterial Stiffness
-
International Society for Vascular HealthCompleted
-
Wolfson Medical CenterCompletedArterial Stiffness | Arterial ElasticityIsrael
-
Salisbury UniversityCompleted
-
University of Missouri-ColumbiaRecruitingAging | Arterial StiffnessUnited States
-
University of ManitobaCompletedArterial StiffnessCanada
-
Alexandria UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedArterial StiffnessTurkey
-
University of Texas at AustinCompleted
-
Towson UniversityCompletedEndothelial Dysfunction | Arterial StiffnessUnited States
Clinical Trials on interval training exercise
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
St. Olavs HospitalNorwegian University of Science and TechnologyCompletedTachycardia, Ventricular | Defibrillators, ImplantableNorway
-
Rigshospitalet, DenmarkCompleted
-
Assaf-Harofeh Medical CenterCompletedMyocardial Infarction | Coronary Artery DiseaseIsrael
-
Instituto de Investigación Sanitaria de la Fundación...Completed
-
University of LeedsCompletedObesity | Cardiovascular Disease | Cognitive Ability, GeneralUnited Kingdom
-
Poznan University of Physical EducationPoznan University of Medical SciencesCompletedHypertension | Obesity | Dyslipidemias | Type 2 Diabetes | Endothelial DysfunctionPoland
-
Georgia State UniversityWithdrawnAnalgesia | Pain, Acute | Exercise Training | Aerobic Exercise | Pain, NeuropathicUnited States
-
Cairo UniversityRecruitingMultiple SclerosisEgypt