Effect of 12 Weeks of Resistive Exercises Versus Aerobic Exercises in Overweight Hypertensive Postmenopausal Women (exercise)

August 16, 2018 updated by: Ghada Ebrahim El Refaye, Cairo University

Exercise and Menopausal Hypertension

Sixty postmenopausal women participated in this study from gynecological outpatient clinic, at Al-Zahra universal Hospital, Al Azhar University, and Cairo. They were first diagnosed to be hypertensive in their early postmenopausal period .Their blood pressure ranged between 140/90mmHg to 170/105mmHg, their ages ranged from 50 to 60 years and their body mass index ranged from 30:35 kg/m2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participants were divided randomly according to closed envelop into three equal groups in number: Group A (RE) consisted of twenty women who participated in the resistive exercise program. Group B (AE) group: consisted of twenty women who participated in an aerobic exercise program. All patients in both groups (A & B) participated in the exercises three times per week for twelve weeks and every session lasted for 45 min and continues their antihypertensive medication

Study Type

Interventional

Enrollment (Actual)

60

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, 11599
        • Al Azhar University

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

50 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All women diagnosed as essential hypertension.
  • All women must be in their early postmenopausal period

Exclusion Criteria:

  • Lesion to higher centers leading to hypertension (embolism)
  • any cardiovascular disease
  • premature menopause
  • surgical menopause
  • severe hypertension
  • diabetic
  • under treatment of hormonal 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: resistive exercise
resistive exercises using elastic band(Thera Band) Sets were at moderate intensity, 8-10 repetitions for every motion for 12 weeks
Device: resistive exercise
resistive exercise by elastic band for 12 weeks
Experimental: Aerobic exercise
Aerobic exercise in form of treadmill walking for 45 minutes for 12 weeks
Device: aerobic exercise in form of treadmill walking
aerobic exercise in form of treadmill walking for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of changes in the systolic blood pressure
Time Frame: 12 weeks
using the mercury column sphygmomanometer
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of changes in the diastolic blood pressure
Time Frame: 12 weeks
using the mercury column sphygmomanometer
12 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: ghada E elrefaye, Professor, Assistant professor of physical therapy for women's health

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)

September 1, 2017

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CairoU89

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

a randomized controlled trial to determine and compare effect of 12 weeks of resistive exercises versus aerobic exercises in treatment of postmenopausal hypertension

IPD Sharing Time Frame

from 1 September 2017 to 1 August 2018

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • CSR

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.

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