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Effect of Resistive Exercise on Insomnia in Post Menopausal Women

Primary Purpose

Sleep Disturbances and Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Resistive exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbances and Insomnia focused on measuring Resistive exercise, insomnia, post menopausal women

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Professor of physical therapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Receive advices to reduce insomnia

Receive advices and resistive exercise

Outcomes

Primary Outcome Measures

Pittsburgh sleep quality index
To determine sleep quality

Secondary Outcome Measures

Insomnia severity index
To determine insomnia

Full Information

First Posted
September 23, 2022
Last Updated
September 23, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05556317
Brief Title
Effect of Resistive Exercise on Insomnia in Post Menopausal Women
Official Title
Effect of Resistive Exercise on Plasma Estradiol , Sleep Quality and Insomnia in Post Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbances and Insomnia
Keywords
Resistive exercise, insomnia, post menopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Resistive exercise on insomnia
Masking
ParticipantOutcomes Assessor
Masking Description
Random generator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Receive advices to reduce insomnia
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Receive advices and resistive exercise
Intervention Type
Behavioral
Intervention Name(s)
Resistive exercise
Intervention Description
advices and resistive exercise
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index
Description
To determine sleep quality
Time Frame
Four week
Secondary Outcome Measure Information:
Title
Insomnia severity index
Description
To determine insomnia
Time Frame
Four week
Other Pre-specified Outcome Measures:
Title
Plasma estradiol
Description
To determine level of plasma estradiol
Time Frame
Four week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Post menopausal women
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age from 50 to 65 years non smokers BMI 25:29.9 post menopausal women suffer from insomnia Exclusion Criteria: post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia women on hormone replacement therapy those with diagnosed osteoporosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esraa Fikry Massoud, Master
Phone
01555358802
Email
fikryesraa148@gmail.com
Facility Information:
Facility Name
Professor of physical therapy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
esraa fikry, Master
Phone
01555358802
Email
fikryesraa148@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Effect of Resistive Exercise on Insomnia in Post Menopausal Women

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