search
Back to results

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

Primary Purpose

Coagulation Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic exercises in addition to diet recommendations
diet recommendations
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coagulation Disorder

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

aerobic exercises in addition to diet

diet recommendations

Arm Description

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

control group will receive diet recommendations

Outcomes

Primary Outcome Measures

coagulation factors
change of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )
sex hormones
change of (estradiol ,testosterone. sex hormone binding globin )

Secondary Outcome Measures

weight
measuring weight in kilograms
height
measuring height in meters

Full Information

First Posted
July 14, 2020
Last Updated
August 9, 2021
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04488341
Brief Title
Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women
Official Title
Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
May 15, 2022 (Anticipated)
Study Completion Date
August 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulation Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercises in addition to diet
Arm Type
Other
Arm Description
The study group will receive aerobic exercises in addition to diet recommendations
Arm Title
diet recommendations
Arm Type
Other
Arm Description
control group will receive diet recommendations
Intervention Type
Other
Intervention Name(s)
aerobic exercises in addition to diet recommendations
Intervention Description
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
Intervention Name(s)
diet recommendations
Intervention Description
control group will receive diet recommendations for 12 weeks
Primary Outcome Measure Information:
Title
coagulation factors
Description
change of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )
Time Frame
12 weeks
Title
sex hormones
Description
change of (estradiol ,testosterone. sex hormone binding globin )
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
weight
Description
measuring weight in kilograms
Time Frame
12 weeks
Title
height
Description
measuring height in meters
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany FM Elsisi, phd
Phone
00966580239275
Ext
966
Email
Elsisihany309@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany fm elsisi, phd
Organizational Affiliation
physical therapy faculty Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hany fm elsisi, Phd
Phone
00966580239275
Ext
966
Email
Elsisihany309@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://Scholar.cu.edu.eg/p_t

Learn more about this trial

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

We'll reach out to this number within 24 hrs