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
About this trial
This is an interventional prevention trial for Coagulation Disorder
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.
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
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
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