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Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women

Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04488341
Enrollment
40
Registered
2020-07-28
Start date
2020-09-20
Completion date
2022-08-20
Last updated
2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder

Brief summary

PURPOSE: to determine the effect of aerobic exercise training on sex hormones and coagulation factors in postmenopausal elderly women BACKGROUND: Cardiovascular disease (CVD) is the largest cause of death in women, and the risk of developing CVD increases after menopause . Because thrombosis is thought to be a cause of most acute cardiovascular events, abnormalities in endogenous coagulation and fibrinolysis may play an important role in the risk of an acute cardiovascular event. Aging is also associated with adverse changes in both coagulation and fibrinolysis. For instance, postmenopausal women exhibit higher fibrinogen levels and lower levels of endogenous fibrinolysis. Physical activity and physical fitness have consistently been linked to lower CVD rates in women. In fact, an inverse association between physical activity and total mortality, as well as a 50% reduction in risk of myocardial infarction, has been observed in physically active postmenopausal women. In addition to the numerous other benefits provided by regular physical activity, one of the mechanisms mediating the cardioprotective effect may be changes in the hemostatic system, particularly fibrinolysis HYPOTHESES: Aerobic exercises may have no effect on sex hormones and coagulation factors in elderly postmenopausal women RESEARCH QUESTION: Do aerobic exercises effect on sex hormones and coagulation factors in elderly postmenopausal women in response to exercises?

Detailed description

It is an interventional study in which 40 women estimated to enroll according to random allocation and assigned into two groups equally. The study group will receive aerobic exercises in addition to diet recommendations while the control group will receive diet recommendations. the aerobic exercises time of session 40-50 min initial 10 min warm up exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to target heart rate 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 .coagulation factors(Prothrombin time, Partial Thromboplastin Time , plasminogen activator inhibitor-1 , fibrinogen and tissue plasminogen activator )will be measured and sex hormones (estradiol ,testosterone. sex hormone binding globin ) pre and post intervention

Interventions

OTHERaerobic exercises in addition to diet recommendations

aerobic exercises time of session 40-50 min initial 10 min warm up exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to target heart rate 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

control group will receive diet recommendations for 12 weeks

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* • forty Postmenopausal women (60-70 y) * Body mass index (BMI) ranged from 35 to 39.9 kg/m2

Exclusion criteria

* • regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin, nitrates, Presently using hormone replacement therapy (HRT) and non steroidal anti-inflammatory drugs, * smoking; * cognitive impairment that will make it difficult to partake in the study * presence of malignant disease * blood donation within the last 6 months * Participation as a subject in any type of study or research during the prior 90 days * hypertension, * having active chronic illness (e.g., rheumatoid arthritis, hyperthyroidism, and inflammatory bowel disease) and diabetes mellitus or other (unstable) endocrine-related diseases * personal history of cardiovascular diseases, * Orthopedic problems inhibiting exercises.

Design outcomes

Primary

MeasureTime frameDescription
coagulation factors12 weekschange of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )
sex hormones12 weekschange of (estradiol ,testosterone. sex hormone binding globin )

Secondary

MeasureTime frameDescription
weight12 weeksmeasuring weight in kilograms
height12 weeksmeasuring height in meters

Countries

Egypt

Contacts

Primary ContactHany FM Elsisi, phd
Elsisihany309@gmail.com00966580239275

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026