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

NCT ID: NCT04488341

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-20
• Study Completion Date: 2022-08-20

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

Conditions

Coagulation Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

aerobic exercises in addition to diet

The study group will receive aerobic exercises in addition to diet recommendations

Group Type: OTHER

aerobic exercises in addition to diet recommendations

Intervention Type: OTHER

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

diet recommendations

Intervention Type: OTHER

control group will receive diet recommendations for 12 weeks

diet recommendations

control group will receive diet recommendations

Group Type: OTHER

diet recommendations

Intervention Type: OTHER

control group will receive diet recommendations for 12 weeks

Interventions

aerobic 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

Intervention Type: OTHER

diet recommendations

control group will receive diet recommendations for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hany Farid Eid morsy Elsisi

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany fm elsisi, phd

Role: PRINCIPAL_INVESTIGATOR

physical therapy faculty Cairo university

Locations

Physical Therapy

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hany FM Elsisi, phd

Role: CONTACT

Elsisihany309@gmail.com

00966580239275 ext. 966

Facility Contacts

hany fm elsisi, Phd

Role: primary

Elsisihany309@gmail.com

00966580239275 ext. 966

Other Identifiers

P.T.REC/012/002676

Identifier Type: -

Identifier Source: org_study_id