NCT05556317

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

September 23, 2022

Last Update Submit

September 23, 2022

Conditions

Sleep Disturbances and Insomnia

Keywords

Resistive exercise, insomnia, post menopausal women

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh sleep quality index

    To determine sleep quality

    Four week

Secondary Outcomes (1)

  • Insomnia severity index

    Four week

Other Outcomes (1)

  • Plasma estradiol

    Four week

Study Arms (2)

Group A

EXPERIMENTAL

Receive advices to reduce insomnia

Behavioral: Resistive exercise

Group B

ACTIVE COMPARATOR

Receive advices and resistive exercise

Behavioral: Resistive exercise

Interventions

Resistive exerciseBEHAVIORAL

advices and resistive exercise

Group AGroup B

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPost menopausal women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 50 to 65 years
  • non smokers
  • BMI 25:29.9
  • post menopausal women suffer from insomnia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor of physical therapy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

ParasomniasSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomnias

Central Study Contacts

Esraa Fikry Massoud, Master

CONTACT

01555358802fikryesraa148@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Random generator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Resistive exercise on insomnia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
esraa fikry massoud yamani

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 27, 2022

Study Start

September 30, 2022

Primary Completion

November 1, 2022

Study Completion

November 15, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Locations

EG(1)