NCT05009238

Brief Summary

Menopause is a natural process in women's life with hormonal fluctuations that cause physical and emotional symptoms such as(Hot flashes, insomnia, physical in activity, unstable mood, difficulties in memory and concentration, anxiety, stress, irritability, unstable body mass, sexual dysfunction, feelings of sadness, infertility, and depression). Balance disturbances are common in the community as a whole and increase in frequency with age. The risk of falling increases from age 45 in women and peaks in the 55-59-year age group. Around the time of the menopause, estrogen production decreases dramatically and bone loss accelerates, which predisposes for fractures if a fall occurs.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

July 23, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

July 23, 2021

Last Update Submit

August 21, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Step length

    the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot measured by cm

    about 6 weeks.

  • step symmetry

    right to left time distribution measured by second

    about 6 weeks.

  • walking speed

    the ratio of distance to the time in which the distance was covered by the subject measured by m/s

    about 6 weeks.

Study Arms (2)

Group (A)

EXPERIMENTAL

Group (A): will receive lumbar stabilization exercises

Other: lumbar stabilization exercises

Group (B)

NO INTERVENTION

Group (B): will be control group.

Interventions

selected exercises will taught to participant and practiced 3 times per week for 6 weeks

Group (A)

Eligibility Criteria

Age45 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Post-menopausal women: Their age will be ranged between 45-59 years old, with low back pain.

You may not qualify if:

  • Infection disease or fever.
  • Foot ulcers.
  • Foot infection or undergoing foot surgery.
  • Recent fracture in foot and toes with unhealed wounds.
  • Thrombotic disease of lower extremities.
  • Deep proprioception loss.
  • Peripheral neuropathy.
  • Gout or advanced arthritis affecting the foot and toes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Hend Hamdy, PHD

CONTACT

Manal el shafei, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of pt for basic science

Study Record Dates

First Submitted

July 23, 2021

First Posted

August 17, 2021

Study Start

October 1, 2022

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share