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

Primary Purpose

Cognitive Decline, Postmenopausal Disorder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic exercise and MIND diet program
MIND diet program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Decline

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

aerobic exercise and MIND diet program

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

Arm Description

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

the control group will receive MIND diet program for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2020
Last Updated
October 5, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04492540
Brief Title
Response of Sex Hormones and Different Functions to Exercise and Diet in Elderly Women
Official Title
Correlation Between Sex Hormones and Different Functions in Response to Aerobic Exercise and MIND Diet in Older Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Postmenopausal Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise and MIND diet program
Arm Type
Other
Arm Description
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
Arm Title
The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program
Arm Type
Other
Arm Description
the control group will receive MIND diet program for 12 weeks
Intervention Type
Other
Intervention Name(s)
aerobic exercise and MIND diet program
Intervention Description
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
Intervention Name(s)
MIND diet program
Intervention Description
control group will receive diet program for 12 weeks
Primary Outcome Measure Information:
Title
sex hormones
Description
level of sex hormones(estradiol ,testosterone. sex hormone binding globin )
Time Frame
12 weeks
Title
cognitive functions
Description
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
Time Frame
12 weeks
Title
functional level
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada e Elrefaye, phd
Organizational Affiliation
physical therapy faculty Cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Physical Therapy
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
one year after completing the study
IPD Sharing Access Criteria
journal publishes the study
IPD Sharing URL
http://Scholar.cu.edu.eg/p_t

Learn more about this trial

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

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