Effect of Resistive Exercise on Insomnia in Post Menopausal Women

September 23, 2022 updated by: Esraa Fikry Massoud Yamani, Cairo University

Effect of Resistive Exercise on Plasma Estradiol , Sleep Quality and Insomnia in Post Menopausal Women

the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Insomnia is a prevalent condition in post menopausal women.resistive exercise might play an important role in insomnia.this trial has two groups ;one will receive advices and the second will receive advices and resistive exercise for four week

Study Type

Interventional

Enrollment (Anticipated)

56

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Professor of physical therapy
        • Contact:

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. age from 50 to 65 years
  2. non smokers
  3. BMI 25:29.9
  4. post menopausal women suffer from insomnia

Exclusion Criteria:

  1. post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia
  2. women on hormone replacement therapy
  3. those with diagnosed osteoporosis

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: Group A
Receive advices to reduce insomnia
Behavioral: Resistive exercise
advices and resistive exercise
Active Comparator: Group B
Receive advices and resistive exercise
Behavioral: Resistive exercise
advices and resistive exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh sleep quality index
Time Frame: Four week
To determine sleep quality
Four week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia severity index
Time Frame: Four week
To determine insomnia
Four week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma estradiol
Time Frame: Four week
To determine level of plasma estradiol
Four week

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 (Anticipated)

September 30, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 15, 2022

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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