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

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?

Study Overview

• Status: Recruiting
• Conditions: Coagulation Disorder
• Intervention / Treatment: Other: aerobic exercises in addition to diet recommendations; Other: diet recommendations

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hany fm elsisi, Phd; Phone Number: 966 00966580239275; Email: Elsisihany309@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Recruiting
    • Physical Therapy
    • Contact: hany fm elsisi, Phd; Phone Number: 966 00966580239275; Email: Elsisihany309@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: aerobic exercises in addition to diet; The study group will receive aerobic exercises in addition to diet recommendations	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; Other: diet recommendations; control group will receive diet recommendations for 12 weeks
Other: diet recommendations; control group will receive diet recommendations	Other: diet recommendations; control group will receive diet recommendations for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	measuring weight in kilograms	12 weeks
height	measuring height in meters	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: hany fm elsisi, phd, physical therapy faculty Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): August 20, 2022

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: P.T.REC/012/002676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: 2 years after completion study
• IPD Sharing Access Criteria: journal publishes the study
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No