Response of Sex Hormones and Different Functions to Exercise and Diet in Elderly Women

NCT ID: NCT04492540

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-20
• Study Completion Date: 2023-09-30

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

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?

Conditions

Cognitive Decline; Postmenopausal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

aerobic exercise and MIND diet program

the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 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

Group Type: OTHER

aerobic exercise and MIND diet program

Intervention Type: OTHER

the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 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

The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program

the control group will receive MIND diet program for 12 weeks

Group Type: OTHER

MIND diet program

Intervention Type: OTHER

control group will receive diet program for 12 weeks

Interventions

aerobic exercise and MIND diet program

the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 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

Intervention Type: OTHER

MIND diet program

control group will receive diet program for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

marwa mahmoud elsayed mahmoud

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ghada e Elrefaye, phd

Role: STUDY_DIRECTOR

physical therapy faculty Cairo university

Locations

Physical Therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002773

Identifier Type: -

Identifier Source: org_study_id