Effect of Interval Training on Arterial Stiffness in Women With Hypertension

March 14, 2022 updated by: Mona Mohamed Taha, Cairo University
this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 17452
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: interval training exercise
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

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe