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
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
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
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
NCT ID
NCT05556317
First Posted
September 23, 2022
Last Updated
September 23, 2022
Sponsor
Cairo University
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
Learn more about this trial
Effect of Resistive Exercise on Insomnia in Post Menopausal Women
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