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

NCT04488341 | Unknown

• 1 other identifier: P.T.REC/012/002676
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Coagulation Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• sex hormones

  change of (estradiol ,testosterone. sex hormone binding globin )

  12 weeks

Secondary Outcomes (2)

• weight

  12 weeks

• height

  12 weeks

Study Arms (2)

aerobic exercises in addition to diet

OTHER

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

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

diet recommendations

OTHER

control group will receive diet recommendations

Other: diet recommendations

Interventions

aerobic exercises in addition to diet recommendations 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

aerobic exercises in addition to diet

diet recommendations OTHER

control group will receive diet recommendations for 12 weeks

aerobic exercises in addition to diet; diet recommendations

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy

Cairo, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• hany fm elsisi, phd

  physical therapy faculty Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany FM Elsisi, phd

CONTACT

00966580239275; Elsisihany309@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 28, 2020
• Study Start: September 20, 2020
• Primary Completion: May 15, 2022
• Study Completion: August 20, 2022
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years after completion study
• Access Criteria: journal publishes the study

Locations

EG (1)