ElderlyNCT05136742
Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes
A study testing aerobic exercise and diet program and diet program in people with Elderly and Hormones, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: to determine the effect of aerobic exercise training and diet on sex hormones , insulin resistance and depression and if is there correlation between these factors effect in postmenopausal obese women BACKGROUND: The practice of regular physical activity is recommended worldwide by different public health… Read more about this study
- Who is it for?
- Ages 55 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly, Hormones, Insulin Resistance
- What is being tested?
- aerobic exercise and diet program and diet program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 20 Apr 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 55 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria
- Sixty Postmenopausal women (55-65 y)
- Body mass index (BMI) ranged from 35to 39.9 kg/m2
- Postmenopausal more than 2 years
Who cannot join
- women receiving weight-reduction interventions
- taking lipid lowering drugs
- 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
- cognitive impairment that will make it difficult to partake in the study
- presence of malignant disease
Show all 9Show fewer
- blood donation within the last 30 days
- Participation as a subject in any type of study or research during the prior 90 days
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes in Postmenopausal Elderly Women: a Randomized Controlled Trial
PURPOSE:
to determine the effect of aerobic exercise training and diet on sex hormones , insulin resistance and depression and if is there correlation between these factors effect in postmenopausal obese women
Read more
BACKGROUND:
The practice of regular physical activity is recommended worldwide by different public health agencies for primary or secondary prevention of many health problems, including cancers. In particular, physical activity is associated with a 25 % reduction in the average risk of cardiovascular diseases among women, and this protective effect appears to be independent of menopausal status. Many interrelated biological mechanisms may underlie this association, such as the effect of physical activity on glucose metabolism, inflammation, immune function, and sex hormones. Indeed, endogenous sex hormones, particularly estrogens, seem to be involved in the initiation, promotion, and progression of tumors. Prolonged exposure to high endogenous hormone levels is considered one of the main risk factors for female breast cancer, with a relative risk of 2.00 (95 % confidence interval (CI): 1.47-2.71) for postmenopausal women with the highest estradiol levels . Several observational studies have found an inverse association between physical activity and circulating estrogen levels . This effect may be mediated by the decrease in fat mass, the main source of estrogens in postmenopausal women. It may also be mediated by the disruption of the menstrual cycle before menopause , especially when exercise is associated with low energy intakes. However, the assessment of the exposure to physical activity remains imprecise, because it is generally only possible to measure it in naturally living subjects using questionnaires
.
HYPOTHESES:
may have no Correlation between sex hormones and insulin resistance and depression in response to exercise and diet in postmenopausal obese women
RESEARCH QUESTION:
Is there Correlation between sex hormones and insulin resistance and depression in response to exercise and diet in postmenopausal obese women?
Read the detailed description
It is an interventional study in which 60 women estimated to enrol according to random allocation and assigned into two groups equal. The study group will receive aerobic exercises in addition to diet recommendations while the control group will receive diet recommendations. the aerobic exercises in form of treadmill training intensity of exercises high intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX)time of session 40 min initial 10 min warm up exercises on treadmill in low intensity and active phase20- 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 exercises 3 times per week for 12 weeks .insulin resistance will be measured by HOMA -IR index and sex hormones (estridol ,testosterone. sex hormone binding globin ) pre and post intervention and use zung self-rating depression scale to assess depression
- Conditions
- Elderly, Hormones, Insulin Resistance, Depression
- Being tested
- aerobic exercise and diet program, diet program
- Medical subject headings
- Insulin Resistance, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise and diet programOther
It is an interventional study in which 60 women estimated to enrol according to random allocation and assigned into two groups equal. The study group will receive aerobic exercises in addition to diet recommendations while the control group will receive diet recommendations. the aerobic exercises in form of treadmill training intensity of exercises high intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX)time of session 40 min initial 10 min warm up exercise on treadmill in low intensity and active phase20- 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 exercises 3 times per week for 12 weeks .insulin resistance will be measured by HOMA -IR index and sex hormones (estridol ,testosterone. sex hormone binding globin ) pre and post intervention and use zung self-rating depression scale to assess depression
diet programOther
balanced restricted diet
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise and diet program | Experimental | aerobic exercise with balanced restricted diet Receives: Other: aerobic exercise and diet program |
| diet program | Active comparator | balanced restricted diet Receives: Other: diet program |
What is being measured
The primary outcome is the main question the study is designed to answer.
sex hormones
sex hormones levels by blood analysis
Measured: 12 weeks
insulin resistance
insulin resistance by HOMA-IR
Measured: 12 weeks
depression
depression levels by SDS scale
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 posted29 Nov 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2022
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies 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
- Treatment
- 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
- marwa M elsayed, Principal investigator, cairo university faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136742
- Sponsor's protocol ID
- no: P.T.REC/012/002774
- Status last verified
- May 2023
- First submitted
- 16 Nov 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing data with other researchers
Publications
Elsayed MM, El Refaye GE, Rabiee A, Abouzeid S, Elsisi HF. Aerobic exercise with diet induces hormonal, metabolic, and psychological changes in postmenopausal obese women. Heliyon. 2022 Mar 24;8(3):e09165. doi: 10.1016/j.heliyon.2022.e09165. eCollection 2022 Mar.
PubMed 35368551
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise With Diet Induces Hormonal, Metabolic, and Psychological Changes in Postmenopausal Elderly Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05136742
- Acronym / sponsor ID
- no: P.T.REC/012/002774
- Conditions
- Elderly, Hormones, Insulin Resistance, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 29 Nov 2021 (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 and diet on sex hormones , insulin resistance and depression and if is there correlation between these factors effect in postmenopausal obese women
BACKGROUND:
The practice of regular physical activity is recommended worldwide by different public health agencies for primary or secondary prevention of many health problems, including cancers. In particular, physical activity is associated with a 25 % reduction in the average risk of cardiovascular diseases among women, and this protective effect appears to be independent of menopausal status. Many interrelated biological mechanisms may underlie this association, such as the effect of physical activity on glucose metabolism, inflammation, immune function, and sex hormones. Indeed, endogenous sex hormones, particularly estrogens, seem to be involved in the initiation, promotion, and progression of tumors. Prolonged exposure to high endogenous hormone levels is considered one of the main risk factors for female breast cancer, with a relative risk of 2.00 (95 % confidence interval (CI): 1.47-2.71) for postmenopausal women with the highest estradiol levels . Several observational studies have found an inverse association between physical activity and circulating estrogen levels . This effect may be mediated by the decrease in fat mass, the main source of estrogens in postmenopausal women. It may also be mediated by the disruption of the menstrual cycle before menopause , especially when exercise is associated with low energy intakes. However, the assessment of the exposure to physical activity remains imprecise, because it is generally only possible to measure it in naturally living subjects using questionnaires
.
HYPOTHESES:
may have no Correlation between sex hormones and insulin resistance and depression in response to exercise and diet in postmenopausal obese women
RESEARCH QUESTION:
Is there Correlation between sex hormones and insulin resistance and depression in response to exercise and diet in postmenopausal obese women?
Detailed description
It is an interventional study in which 60 women estimated to enrol according to random allocation and assigned into two groups equal. The study group will receive aerobic exercises in addition to diet recommendations while the control group will receive diet recommendations. the aerobic exercises in form of treadmill training intensity of exercises high intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX)time of session 40 min initial 10 min warm up exercises on treadmill in low intensity and active phase20- 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 exercises 3 times per week for 12 weeks .insulin resistance will be measured by HOMA -IR index and sex hormones (estridol ,testosterone. sex hormone binding globin ) pre and post intervention and use zung self-rating depression scale to assess depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise and diet program | Experimental | Other: aerobic exercise and diet programaerobic exercise with balanced restricted diet |
| diet program | Active comparator | Other: diet programbalanced restricted diet |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inclusion criteria
- Sixty Postmenopausal women (55-65 y)
- Body mass index (BMI) ranged from 35to 39.9 kg/m2
- Postmenopausal more than 2 years
Key exclusion criteria (9 listed)
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 diet programIt is an interventional study in which 60 women estimated to enrol according to random allocation and assigned into two groups equal. The study group will receive aerobic exercises in addition to diet recommendations while the control group will receive diet recommendations. the aerobic exercises in form of treadmill training intensity of exercises high intensity, target heart rate (THR) will be60-70% of heart maximum (HR MAX)time of session 40 min initial 10 min warm up exercise on treadmill in low intensity and active phase20- 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 exercises 3 times per week for 12 weeks .insulin resistance will be measured by HOMA -IR index and sex hormones (estridol ,testosterone. sex hormone binding globin ) pre and post intervention and use zung self-rating depression scale to assess depression | Other | aerobic exercise and diet program |
| diet programbalanced restricted diet | Other | diet program |
Primary outcome
sex hormones
Time frame: 12 weeks
sex hormones levels by blood analysis
insulin resistance
Time frame: 12 weeks
insulin resistance by HOMA-IR
depression
Time frame: 12 weeks
depression levels by SDS scale
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 9 May 2023.
- Derived from this study: PubMed 35368551Elsayed MM, El Refaye GE, Rabiee A, Abouzeid S, Elsisi HF. Aerobic exercise with diet induces hormonal, metabolic, and psychological changes in postmenopausal obese women. Heliyon. 2022 Mar 24;8(3):e09165. doi: 10.1016/j.heliyon.2022.e09165. eCollection 2022 Mar.
- Individual participant dataSharing planned: Yes. sharing data with other researchers
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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.
marwa M elsayed principal investigator
cairo university faculty of physical therapy
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 diet program and diet program in people with Elderly and Hormones, 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 4 inclusion and 9 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 9 May 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?
On the ClinicalTrials.gov record for NCT05136742, which also lists 1 linked publication.
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 9 May 2023.