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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Coagulation Disorder

Treatments

Other: diet recommendations
Other: aerobic exercises in addition to diet recommendations

Study type

Interventional

Funder types

Other

Identifiers

NCT04488341
P.T.REC/012/002676

Details and patient eligibility

About

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?

Full 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

Enrollment

40 estimated patients

Sex

Female

Ages

60 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

aerobic exercises in addition to diet
Other group
Description:
The study group will receive aerobic exercises in addition to diet recommendations
Treatment:
Other: diet recommendations
Other: aerobic exercises in addition to diet recommendations
diet recommendations
Other group
Description:
control group will receive diet recommendations
Treatment:
Other: diet recommendations

Trial contacts and locations

1

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Central trial contact

Hany FM Elsisi, phd

Data sourced from clinicaltrials.gov

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