NCT03637985

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 7, 2018

Last Update Submit

August 16, 2018

Conditions

Keywords

resistive exercisesaerobicMenopausehypertension

Outcome Measures

Primary Outcomes (1)

  • Assessment of changes in the systolic blood pressure

    using the mercury column sphygmomanometer

    12 weeks

Secondary Outcomes (1)

  • Assessment of changes in the diastolic blood pressure

    12 weeks

Study Arms (2)

resistive exercise

EXPERIMENTAL

resistive exercises using elastic band(Thera Band) Sets were at moderate intensity, 8-10 repetitions for every motion for 12 weeks

Device: resistive exercise

Aerobic exercise

EXPERIMENTAL

Aerobic exercise in form of treadmill walking for 45 minutes for 12 weeks

Device: aerobic exercise in form of treadmill walking

Interventions

resistive exercise by elastic band for 12 weeks

resistive exercise

aerobic exercise in form of treadmill walking for 12 weeks

Aerobic exercise

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Lesion to higher centers leading to hypertension (embolism)
  • any cardiovascular disease
  • premature menopause
  • surgical menopause
  • severe hypertension
  • diabetic
  • under treatment of hormonal therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University

Cairo, 11599, Egypt

Location

MeSH Terms

Conditions

Motor ActivityHypertension

Condition Hierarchy (Ancestors)

BehaviorVascular DiseasesCardiovascular Diseases

Study Officials

  • ghada E elrefaye, Professor

    Assistant professor of physical therapy for women's health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The allocation was concealed in sequentially numbered opaque envelopes by a blinded and an independent research assistant and selected 69 individuals randomly into the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for women's health

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 20, 2018

Study Start

September 1, 2017

Primary Completion

July 30, 2018

Study Completion

August 1, 2018

Last Updated

August 20, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
SAP, ICF, CSR
Time Frame
from 1 September 2017 to 1 August 2018

Locations