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Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes

Primary Purpose

Elderly, Hormones, Insulin Resistance

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

About this trial

This is an interventional treatment trial for Elderly

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- Inclusion criteria

  • Sixty Postmenopausal women (55-65 y)
  • Body mass index (BMI) ranged from 35to 39.9 kg/m2
  • Postmenopausal more than 2 years

Exclusion Criteria:

  • Exclusion criteria

    • women receiving weight-reduction interventions
    • taking lipid lowering drugs
    • 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
    • cognitive impairment that will make it difficult to partake in the study
    • 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
    • smoking

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aerobic exercise and diet program

diet program

Arm Description

aerobic exercise with balanced restricted diet

balanced restricted diet

Outcomes

Primary Outcome Measures

sex hormones
sex hormones levels by blood analysis
insulin resistance
insulin resistance by HOMA-IR
depression
depression levels by SDS scale

Secondary Outcome Measures

Full Information

First Posted
November 16, 2021
Last Updated
May 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05136742
Brief Title
Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes
Official Title
Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes in Postmenopausal Elderly Women: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
April 20, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
PURPOSE: to determine the effect of aerobic exercise training and diet on sex hormones , insulin resistance and depression and if is there correlation between these factors effect in postmenopausal obese women BACKGROUND: The practice of regular physical activity is recommended worldwide by different public health agencies for primary or secondary prevention of many health problems, including cancers. In particular, physical activity is associated with a 25 % reduction in the average risk of cardiovascular diseases among women, and this protective effect appears to be independent of menopausal status. Many interrelated biological mechanisms may underlie this association, such as the effect of physical activity on glucose metabolism, inflammation, immune function, and sex hormones. Indeed, endogenous sex hormones, particularly estrogens, seem to be involved in the initiation, promotion, and progression of tumors. Prolonged exposure to high endogenous hormone levels is considered one of the main risk factors for female breast cancer, with a relative risk of 2.00 (95 % confidence interval (CI): 1.47-2.71) for postmenopausal women with the highest estradiol levels . Several observational studies have found an inverse association between physical activity and circulating estrogen levels . This effect may be mediated by the decrease in fat mass, the main source of estrogens in postmenopausal women. It may also be mediated by the disruption of the menstrual cycle before menopause , especially when exercise is associated with low energy intakes. However, the assessment of the exposure to physical activity remains imprecise, because it is generally only possible to measure it in naturally living subjects using questionnaires . HYPOTHESES: may have no Correlation between sex hormones and insulin resistance and depression in response to exercise and diet in postmenopausal obese women RESEARCH QUESTION: Is there Correlation between sex hormones and insulin resistance and depression in response to exercise and diet in postmenopausal obese women?
Detailed Description
It is an interventional study in which 60 women estimated to enrol according to random allocation and assigned into two groups equal. The study group will receive aerobic exercises in addition to diet recommendations while the control group will receive diet recommendations. the aerobic exercises in form of treadmill training intensity of exercises high intensity, target heart rate (THR) will be60-70% 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 exercises 3 times per week for 12 weeks .insulin resistance will be measured by HOMA -IR index and sex hormones (estridol ,testosterone. sex hormone binding globin ) pre and post intervention and use zung self-rating depression scale to assess depression

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Hormones, Insulin Resistance, Depression

7. Study Design

Primary Purpose
Treatment
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 diet program
Arm Type
Experimental
Arm Description
aerobic exercise with balanced restricted diet
Arm Title
diet program
Arm Type
Active Comparator
Arm Description
balanced restricted diet
Intervention Type
Other
Intervention Name(s)
aerobic exercise and diet program
Intervention Description
It is an interventional study in which 60 women estimated to enrol according to random allocation and assigned into two groups equal. The study group will receive aerobic exercises in addition to diet recommendations while the control group will receive diet recommendations. the aerobic exercises in form of treadmill training intensity of exercises high intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX)time of session 40 min initial 10 min warm up exercise 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 exercises 3 times per week for 12 weeks .insulin resistance will be measured by HOMA -IR index and sex hormones (estridol ,testosterone. sex hormone binding globin ) pre and post intervention and use zung self-rating depression scale to assess depression
Intervention Type
Other
Intervention Name(s)
diet program
Intervention Description
balanced restricted diet
Primary Outcome Measure Information:
Title
sex hormones
Description
sex hormones levels by blood analysis
Time Frame
12 weeks
Title
insulin resistance
Description
insulin resistance by HOMA-IR
Time Frame
12 weeks
Title
depression
Description
depression levels by SDS scale
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Inclusion criteria Sixty Postmenopausal women (55-65 y) Body mass index (BMI) ranged from 35to 39.9 kg/m2 Postmenopausal more than 2 years Exclusion Criteria: Exclusion criteria women receiving weight-reduction interventions taking lipid lowering drugs 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 cognitive impairment that will make it difficult to partake in the study 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 smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marwa M elsayed
Organizational Affiliation
cairo university faculty of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
sharing data with other researchers
IPD Sharing Time Frame
5 years after publication
IPD Sharing Access Criteria
published journal
Citations:
PubMed Identifier
35368551
Citation
Elsayed MM, El Refaye GE, Rabiee A, Abouzeid S, Elsisi HF. Aerobic exercise with diet induces hormonal, metabolic, and psychological changes in postmenopausal obese women. Heliyon. 2022 Mar 24;8(3):e09165. doi: 10.1016/j.heliyon.2022.e09165. eCollection 2022 Mar.
Results Reference
derived

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Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes

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