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

NCT04492540 | Completed

• 1 other identifier: P.T.REC/012/002773
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Decline; Postmenopausal Disorder

Outcome Measures

Primary Outcomes (3)

• sex hormones

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

  12 weeks

• 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

  12 weeks

• 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

  12 weeks

Study Arms (2)

aerobic exercise and MIND diet program

OTHER

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

Other: aerobic exercise and MIND diet program

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

OTHER

the control group will receive MIND diet program for 12 weeks

Other: MIND diet program

Interventions

aerobic exercise and MIND diet program 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

aerobic exercise and MIND diet program

MIND diet program OTHER

control group will receive diet program for 12 weeks

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

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sixty Postmenopausal women (60-70 y)
• Body mass index (BMI) ranged from 30 to 39.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• ghada e Elrefaye, phd

  physical therapy faculty Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: December 20, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year after completing the study
• Access Criteria: journal publishes the study

Locations

EG (1)