Response of Sex Hormones and Different Functions to Exercises in Postmenopausal Elderly Women

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04492540
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
4.3
Actual Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is an interventional study in which 60 women estimated to enroll according to random allocation and divided into two groups. The study group will receive aerobic exercise in addition to diet restriction while the control group will receive diet recommendations. the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 50-60% of heart maximum (HR MAX), time of session 40 min initial 10 min warm up exercise on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks .different functions and markers will be measured and sex hormones (estradiol ,testosterone. sex hormone binding globin ) pre and post

Condition or DiseaseIntervention/TreatmentPhase
  • Other: aerobic exercise and diet program
  • Other: diet program
N/A

Detailed Description

PURPOSE:

to determine the effect of aerobic exercise and diet on sex hormones and different functions and markers, and if is there correlation between two factors effect in postmenopausal elderly women

BACKGROUND:

Alzheimer's disease (AD) is the most common neurodegenerative disease, accounting for more than 50% of all dementia types. Its twice more common in females which could be due to increased longevity and sex difference in brain size .Estrogen has neurotrophic action in areas involved in memory and cognition. Post-menopausal women are at increased risk than their male counterpart. Women with Alzheimer have lower endogenous estrogen level which lead to the hypothesis that estrogen could be neuroprotective. Estrogen and androgen receptors are widely distributed throughout the brain e.g. in the cerebral cortex, amygdala, hypo-thalamus and also in the hippocampus which is important for cognitive functioning. There are shown clear associations between sex hormones and activities in memory, emotional and rewarding circuits in the brain measured with functional magnetic resonance imaging, several significant correlations were found between serum hormone levels and spatial ability. High absolute estrogen levels, a high estrogen/testosterone ratio and increasing levels during estrogen treatment were all associated with lower spatial ability. This is in agreement with many previous reports of sex differences where women in general tend to perform worse than men in this specific aspect of cognitive function. In menstruating women, a deterioration of spatial ability was demonstrated during high levels of circulating estrogen, and it was improved during the menstrual phase of the cycle when hormone levels are lowest.

HYPOTHESES:

There is no correlation between sex hormones and different functions and markers in response to aerobic exercise and diet in elderly postmenopausal women

RESEARCH QUESTION:

Is there correlation between sex hormones and different functions and markers in elderly postmenopausal women in response to aerobic exercise and dietary restriction?

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Correlation Between Sex Hormones and Different Functions and Markers in Response to Aerobic Exercise and Dietary Restriction in Postmenopausal Elderly Women
Actual Study Start Date :
Dec 20, 2020
Actual Primary Completion Date :
Mar 30, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Other: aerobic exercise and diet program

the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 50-60% of heart maximum (HR MAX), time of session 40 min initial 10 min warm up exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks

Other: aerobic exercise and diet program
the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be50-60% of heart maximum (HR MAX), time of session 40 min initial 10 min warm up exercises on treadmill in low intensity and active phase20- 30 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks

Other: diet program

the control group will receive diet program for 12 weeks

Other: diet program
control group will receive diet program for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. sex hormones [12 weeks]

    level of sex hormones(estradiol ,testosterone. sex hormone binding globin )

  2. cognitive functions [12 weeks]

    cognitive functions by Rowland Universal Dementia Assessment Scale(RUDAS)which has a high score of 30 points, where the least scores indicate severe cognitive impairment

  3. functional level [12 weeks]

    measuring functional level by Functional Independence Measure(FIM) it is ranging from 18 (lowest) to 126 (highest) level of independence: Items are scored on a 7-point ordinal scale, with 7 reflecting complete independency and 1 reflecting total dependence. Scores of 1 to 5 indicate a need for caregiver assistance

  4. insulin resistance [12 weeks]

    HOMA-IR

  5. depression [12 weeks]

    SDS scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • Sixty Postmenopausal women (60-70 y)

  • Body mass index (BMI) ranged from 30 to 39.9 kg/m2

Exclusion Criteria:
  • • regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin, nitrates, Presently using sex hormones)

  • having active chronic illness (e.g., rheumatoid arthritis, hyperthyroidism, and inflammatory bowel disease) and diabetes mellitus or other (unstable) endocrine-related diseases

  • presence of malignant disease

  • blood donation within the last 30 days

  • Participation as a subject in any type of study or research during the prior 90 days

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Physical TherapyCairoEgypt11432

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: ghada e Elrefaye, phd, physical therapy faculty Cairo university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
marwa mahmoud elsayed mahmoud, principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT04492540
Other Study ID Numbers:
  • P.T.REC/012/002773
First Posted:
Jul 30, 2020
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021