Depression Clinical Trial
Official title:
Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes in Postmenopausal Elderly Women: a Randomized Controlled Trial
Verified date | May 2023 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 60 |
Est. completion date | April 20, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 55 Years to 65 Years |
Eligibility | 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., ß-blockers, a-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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Physical Therapy | Cairo | Dokki |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sex hormones | sex hormones levels by blood analysis | 12 weeks | |
Primary | insulin resistance | insulin resistance by HOMA-IR | 12 weeks | |
Primary | depression | depression levels by SDS scale | 12 weeks |
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