- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06224465
Effect of Anti-aging Therapy on Fitness Enhancement in Perimenopausal Women
Study Overview
Detailed Description
This study will be carried on forty perimenopausal women. They were selected randomly from outpatient clinic of El Kaser El-Einy University Hospital, Cairo University, their age ranged from 40 to 50 years.
Group A ( Control group):
It consisted of 20 perimenopausal women. They received anti-aging diet instructions.
Group B ( Experimental group):
It will be consisted of 20 perimenopausal women.They received anti-aging therapy (Aerobic, Flexibility and strengthening exercises) with anti aging diet instructions.
Randomization:
Randomization of sample selection was achieved using closed envelop way. Classification of the sample by simple random way into two groups equal in number, twenty for each group by using forty closed envelop, each twenty envelop contained a name of a group from the two groups (Group A) or (Group B) and asking each woman to choose one envelop from them, each woman attended to the group according the name of the group written in her envelop.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt, 12662
- Faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: control group
Antiaging diet instructions
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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.
Other Names:
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Experimental: intervention group
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 |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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6-minute walking test
Time Frame: 12 weeks
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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.
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12 weeks
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toe touch test
Time Frame: 12 weeks
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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.
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12 weeks
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hand held dynamometer
Time Frame: 12 weeks
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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.
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12 weeks
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body composition analysis
Time Frame: 12 weeks
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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
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amel Yousef, Cairo university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/005035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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