Cognitive DeclineNCT04492540
Response of Sex Hormones and Different Functions to Exercise and Diet in Elderly Women
A study testing aerobic exercise and MIND diet program and MIND diet program in people with Cognitive Decline and Postmenopausal Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
It is an interventional study in which 60 women estimated to enroll according to random allocation and divided into two groups. The study group will receive aerobic exercise in addition to diet restriction while the control group will receive diet recommendations. Read more about this study
- Who is it for?
- Ages 60 to 70 years, women only
- Conditions the study is for
- Cognitive Decline, Postmenopausal Disorder
- What is being tested?
- aerobic exercise and MIND diet program and MIND diet program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2020to 30 Sep 2023
- 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
- • Sixty Postmenopausal women (60-70 y)
- Body mass index (BMI) ranged from 30 to 39.9 kg/m2
Who cannot join
- • regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin, nitrates, Presently using sex hormones)
- having active chronic illness (e.g., rheumatoid arthritis, hyperthyroidism, and inflammatory bowel disease) and diabetes mellitus or other (unstable) endocrine-related diseases
- presence of malignant disease
- blood donation within the last 30 days
- Participation as a subject in any type of study or research during the prior 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Sex Hormones and Different Functions in Response to Aerobic Exercise and MIND Diet in Older Adult Women
It is an interventional study in which 60 women estimated to enroll according to random allocation and divided into two groups. The study group will receive aerobic exercise in addition to diet restriction while the control group will receive diet recommendations. the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 50-60% of heart maximum (HR MAX), time of session 40 min initial 10 min warm up exercise on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks .different functions and markers will be measured and sex hormones (estradiol ,testosterone. sex hormone binding globin ) pre and post
Read the detailed description
PURPOSE:
to determine the effect of aerobic exercise and diet on sex hormones and different functions and markers, and if is there correlation between two factors effect in postmenopausal elderly women
BACKGROUND:
Alzheimer's disease (AD) is the most common neurodegenerative disease, accounting for more than 50% of all dementia types. Its twice more common in females which could be due to increased longevity and sex difference in brain size .Estrogen has neurotrophic action in areas involved in memory and cognition. Post-menopausal women are at increased risk than their male counterpart. Women with Alzheimer have lower endogenous estrogen level which lead to the hypothesis that estrogen could be neuroprotective. Estrogen and androgen receptors are widely distributed throughout the brain e.g. in the cerebral cortex, amygdala, hypo-thalamus and also in the hippocampus which is important for cognitive functioning. There are shown clear associations between sex hormones and activities in memory, emotional and rewarding circuits in the brain measured with functional magnetic resonance imaging, several significant correlations were found between serum hormone levels and spatial ability. High absolute estrogen levels, a high estrogen/testosterone ratio and increasing levels during estrogen treatment were all associated with lower spatial ability. This is in agreement with many previous reports of sex differences where women in general tend to perform worse than men in this specific aspect of cognitive function. In menstruating women, a deterioration of spatial ability was demonstrated during high levels of circulating estrogen, and it was improved during the menstrual phase of the cycle when hormone levels are lowest.
HYPOTHESES:
There is no correlation between sex hormones and different functions and markers in response to aerobic exercise and diet in elderly postmenopausal women
RESEARCH QUESTION:
Is there correlation between sex hormones and different functions and markers in elderly postmenopausal women in response to aerobic exercise and dietary restriction?
- Conditions
- Cognitive Decline, Postmenopausal Disorder
- Being tested
- aerobic exercise and MIND diet program, MIND diet program
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise and MIND diet programOther
the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks
MIND diet programOther
control group will receive diet program for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise and MIND diet program | Other | the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks Receives: Other: aerobic exercise and MIND diet program |
| The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program | Other | the control group will receive MIND diet program for 12 weeks Receives: Other: MIND diet program |
What is being measured
The primary outcome is the main question the study is designed to answer.
sex hormones
level of sex hormones(estradiol ,testosterone. sex hormone binding globin )
Measured: 12 weeks
cognitive functions
cognitive functions by Rowland Universal Dementia Assessment Scale(RUDAS)which has a high score of 30 points, where the least scores indicate severe cognitive impairment
Measured: 12 weeks
functional level
measuring functional level by Functional Independence Measure(FIM) it is ranging from 18 (lowest) to 126 (highest) level of independence: Items are scored on a 7-point ordinal scale, with 7 reflecting complete independency and 1 reflecting total dependence. Scores of 1 to 5 indicate a need for caregiver assistance
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 posted30 Jul 2020
- Study start20 Dec 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa mahmoud elsayed mahmoud, Cairo University
- Investigators
- ghada e Elrefaye, phd, Study director, physical therapy faculty Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492540
- Sponsor's protocol ID
- P.T.REC/012/002773
- Status last verified
- Oct 2023
- First submitted
- 27 Jul 2020
- Last updated
- 6 Oct 2023
- 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 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Sex Hormones and Different Functions in Response to Aerobic Exercise and MIND Diet in Older Adult Women
- ClinicalTrials.gov ID
- NCT04492540
- Acronym / sponsor ID
- P.T.REC/012/002773
- Conditions
- Cognitive Decline, Postmenopausal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 30 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.
It is an interventional study in which 60 women estimated to enroll according to random allocation and divided into two groups. The study group will receive aerobic exercise in addition to diet restriction while the control group will receive diet recommendations. the aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 50-60% of heart maximum (HR MAX), time of session 40 min initial 10 min warm up exercise on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks .different functions and markers will be measured and sex hormones (estradiol ,testosterone. sex hormone binding globin ) pre and post
Detailed description
PURPOSE:
to determine the effect of aerobic exercise and diet on sex hormones and different functions and markers, and if is there correlation between two factors effect in postmenopausal elderly women
BACKGROUND:
Alzheimer's disease (AD) is the most common neurodegenerative disease, accounting for more than 50% of all dementia types. Its twice more common in females which could be due to increased longevity and sex difference in brain size .Estrogen has neurotrophic action in areas involved in memory and cognition. Post-menopausal women are at increased risk than their male counterpart. Women with Alzheimer have lower endogenous estrogen level which lead to the hypothesis that estrogen could be neuroprotective. Estrogen and androgen receptors are widely distributed throughout the brain e.g. in the cerebral cortex, amygdala, hypo-thalamus and also in the hippocampus which is important for cognitive functioning. There are shown clear associations between sex hormones and activities in memory, emotional and rewarding circuits in the brain measured with functional magnetic resonance imaging, several significant correlations were found between serum hormone levels and spatial ability. High absolute estrogen levels, a high estrogen/testosterone ratio and increasing levels during estrogen treatment were all associated with lower spatial ability. This is in agreement with many previous reports of sex differences where women in general tend to perform worse than men in this specific aspect of cognitive function. In menstruating women, a deterioration of spatial ability was demonstrated during high levels of circulating estrogen, and it was improved during the menstrual phase of the cycle when hormone levels are lowest.
HYPOTHESES:
There is no correlation between sex hormones and different functions and markers in response to aerobic exercise and diet in elderly postmenopausal women
RESEARCH QUESTION:
Is there correlation between sex hormones and different functions and markers in elderly postmenopausal women in response to aerobic exercise and dietary restriction?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise and MIND diet program | Other | Other: aerobic exercise and MIND diet programthe aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be 60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks |
| The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program | Other | Other: MIND diet programthe control group will receive MIND diet program for 12 weeks |
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)
- • Sixty Postmenopausal women (60-70 y)
Key exclusion criteria (5 listed)
- • regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin, nitrates, Presently using sex hormones)
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 exercise and MIND diet programthe aerobic exercise in form of treadmill training intensity of exercise moderate intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX), time of session 60 min initial 10 min warm up exercise on treadmill in low intensity and target phase 40 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercise 3 times per week for 12 weeks | Other | aerobic exercise and MIND diet program |
| MIND diet programcontrol group will receive diet program for 12 weeks | Other | The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet program |
Primary outcome
sex hormones
Time frame: 12 weeks
level of sex hormones(estradiol ,testosterone. sex hormone binding globin )
cognitive functions
Time frame: 12 weeks
cognitive functions by Rowland Universal Dementia Assessment Scale(RUDAS)which has a high score of 30 points, where the least scores indicate severe cognitive impairment
functional level
Time frame: 12 weeks
measuring functional level by Functional Independence Measure(FIM) it is ranging from 18 (lowest) to 126 (highest) level of independence: Items are scored on a 7-point ordinal scale, with 7 reflecting complete independency and 1 reflecting total dependence. Scores of 1 to 5 indicate a need for caregiver assistance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- 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.
ghada e Elrefaye, phd study director
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 exercise and MIND diet program and MIND diet program in people with Cognitive Decline and Postmenopausal 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 5 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: finished, as of the sponsor's last update on 6 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sex hormones (time frame: 12 weeks). The study lists 3 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 6 Oct 2023.