NCT06224465

Brief Summary

Aging is an important fact to consider from the woman's health perspective. One of the most significant stages of aging is menopause, in which involves physical, psychological, and social changes in life

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

January 16, 2024

Last Update Submit

October 5, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 6-minute walking test

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    12 weeks

  • toe touch test

    This test measures the flexibility of the lower back and hamstrings, and is a valid measure of this.The toe touch test is a common test of flexibility, and is an easy and quick test to perform. If using the standard testing procedure, there is a lot of published data to use for comparison.

    12 weeks

  • hand held dynamometer

    Hand held dynamometer demonstrated an excellent intra- and inter-rater reliability for assessment of isometric lumbar muscles strength of healthy subject at clinical setting as it is simple to use, portable and cost-effective for the precise measurement.

    12 weeks

  • body composition analysis

    Body composition is a method of describing what the body is made of. It includes fat, protein, minerals and body water. It also describes weight more accurately than BMI. Body composition analysis can accurately show changes in fat mass, muscle mass, and body fat percentage. This can help validate services

    12 weeks

Study Arms (2)

control group

PLACEBO COMPARATOR

Antiaging diet instructions

Other: aerobic exercises

intervention group

EXPERIMENTAL

1. aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks 2. Muscle strength Exercises: For upper extremity : hand grip exercise, arm flexion exercise ten repetition for each exercise three times per week. Theraband exercises for upper limb exercise ten repetition for each exercise three times per week. 3. Flexibility Exercise : Curl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week. Lateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks and anti aging diet instruction

Other: aerobic exercises

Interventions

Antiaging diet instruction :Be aware of the amount of calories, Reduce overall fat and sugar intake, Drink at least 10 glasses of water every day in order to remain healthy. d. Eat a variety of complex carbohydrates and vegetables instead of bread, rice, and corn.

Also known as: flexibility exercises, strengthening exercises, anti aging diet instruction
control groupintervention group

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • They complaining from fatigue, hot flushes and irregular period.
  • Their Body Mass Index (BMI) between 25 to 30 .
  • Their age ranged from 40 to 50 years old.
  • The assessment procedures will be conducted on the same time of the day pre/post treatment.

You may not qualify if:

  • Women with comorbidities such as cardiac disease and chest diseases as pulmonary fibrosis.
  • Women received medications that might affect the neuromuscular functions at least three months before or during the study course.
  • Women suffered from mental or psychological disorders.
  • Women suffered from inflammatory diseases such as rheumatoid arthritis or polymyalgia rheumatic.
  • Women complaining from osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo University

Giza, 12662, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Amel Yousef

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: intervention: aerobic exercises: walking :30 min on treadmill 30min at least three times per week for 12 weeks 2)Muscle strength Exercises: For upper extremity : hand grip exercise, arm flexion exercise ten repetition for each exercise three times per week. Theraband exercises for upper limb exercise ten repetition for each exercise three times per week. 3\) Flexibility Exercise : Curl up exercise and Seat and reach up exercises exercise ten repetition for each exercise three times per week. Lateral flexibility exercises for ten repetition for each exercise three times per week,for 12 weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

January 20, 2024

Primary Completion

July 20, 2024

Study Completion

July 31, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations