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
About this trial
This is an interventional treatment trial for Elderly
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
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
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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