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

Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488341
• Other study ID #: P.T.REC/012/002676
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: August 20, 2022

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: Hany FM Elsisi, phd
• Phone: 00966580239275
• Email: Elsisihany309[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 20, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 70 Years

Eligibility

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., ß-blockers, a-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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders

Intervention

Other:
• 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
• diet recommendations
control group will receive diet recommendations for 12 weeks

Locations

Country	Name	City	State
Egypt	Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coagulation factors	change of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )	12 weeks
Primary	sex hormones	change of (estradiol ,testosterone. sex hormone binding globin )	12 weeks
Secondary	weight	measuring weight in kilograms	12 weeks
Secondary	height	measuring height in meters	12 weeks