Coagulation DisorderNCT04488341
Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women
A study testing aerobic exercises in addition to diet recommendations and diet recommendations in people with Coagulation Disorder, run by Cairo University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 60 to 70 years, women only
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- aerobic exercises in addition to diet recommendations and diet recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2020to 20 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • forty Postmenopausal women (60-70 y)
- Body mass index (BMI) ranged from 35 to 39.9 kg/m2
Who cannot join
- • 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Physical Therapy
Cairo, 11432
hany fm elsisi, Phd, 00966580239275 ext. 966, Elsisihany309@gmail.com
About this study
PURPOSE:
to determine the effect of aerobic exercise training on sex hormones and coagulation factors in postmenopausal elderly women
Read more
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?
Read the 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
- Conditions
- Coagulation Disorder
- Being tested
- aerobic exercises in addition to diet recommendations, diet recommendations
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercises in addition to diet recommendationsOther
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 recommendationsOther
control group will receive diet recommendations for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercises in addition to diet | Other | The study group will receive aerobic exercises in addition to diet recommendations Receives: Other: aerobic exercises in addition to diet recommendations; Other: diet recommendations |
| diet recommendations | Other | control group will receive diet recommendations Receives: Other: diet recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
coagulation factors
change of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )
Measured: 12 weeks
sex hormones
change of (estradiol ,testosterone. sex hormone binding globin )
Measured: 12 weeks
Secondary outcomes (2)
weight
measuring weight in kilograms
Measured: 12 weeks
height
measuring height in meters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start20 Sep 2020
- Primary completion15 May 2022 (estimated)
- Study completion20 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Farid Eid morsy Elsisi, Cairo University
- Investigators
- hany fm elsisi, phd, Principal investigator, physical therapy faculty Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488341
- Sponsor's protocol ID
- P.T.REC/012/002676
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women
- ClinicalTrials.gov ID
- NCT04488341
- Acronym / sponsor ID
- P.T.REC/012/002676
- Conditions
- Coagulation Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 20 Aug 2022 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercises in addition to diet | Other | Other: aerobic exercises in addition to diet recommendations, Other: diet recommendationsThe study group will receive aerobic exercises in addition to diet recommendations |
| diet recommendations | Other | Other: diet recommendationscontrol group will receive diet recommendations |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • forty Postmenopausal women (60-70 y)
Key exclusion criteria (10 listed)
- • regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin, nitrates, Presently using hormone replacement therapy (HRT) and non steroidal anti-inflammatory drugs,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercises in addition to diet recommendationsaerobic 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 | aerobic exercises in addition to diet |
| diet recommendationscontrol group will receive diet recommendations for 12 weeks | Other | aerobic exercises in addition to diet, diet recommendations |
Primary outcome
coagulation factors
Time frame: 12 weeks
change of selected coagulation factors by blood analysis (plasminogen activator inhibitor-1 ,tissue plasminogen activator ,Prothrombin time ,Partial Thromboplastin time ,fibrinogen )
sex hormones
Time frame: 12 weeks
change of (estradiol ,testosterone. sex hormone binding globin )
2 secondary outcomes
weight
Time frame: 12 weeks
height
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hany fm elsisi, phd principal investigator
physical therapy faculty Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercises in addition to diet recommendations and diet recommendations in people with Coagulation Disorder, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany FM Elsisi, phd (00966580239275 ext. 966, Elsisihany309@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coagulation factors (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.