Effect of Resistive Exercise on Insomnia in Post Menopaus... | NCT05556317

Studies
Effect of Resistive Exercise on Insomnia in Post Menopausal Women

NCT05556317

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 27, 2022Actual

Enrollment

56Estimated

Phase

Not Applicable

Conditions

Sleep Disturbances and Insomnia

Interventions

Resistive exercise

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2022Estimated

Primary Completion Date

Nov 1, 2022Estimated

Completion Date

Nov 15, 2022Estimated

First Submitted Date

Sep 23, 2022

First Submission Date that Met QC Criteria

Sep 23, 2022

First Posted Date

Sep 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2022

Last Update Posted Date

Sep 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Receive advices to reduce insomnia	Behavioral: Resistive exercise
Group B	Active Comparator	Receive advices and resistive exercise	Behavioral: Resistive exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistive exercise	Behavioral	advices and resistive exercise	Group A Group B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Post menopausal women

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Esraa Fikry Massoud, Master	Contact	01555358802		fikryesraa148@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Professor of physical therapy	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020447	Parasomnias
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided