Insulin ResistanceNCT04471506
Effect of Interval Aerobic Training and Mindfulness Breathing on Hormonal, Metabolic, and Tumor Markers in Postmenopausal
A study testing interval training, diet recommendations and mindfulness breathing in people with Insulin Resistance, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: to determine the effect of interval training and mindfulness breathing on sex hormones, metabolic and tumor markers BACKGROUND: Cancer is one of death top causes in many countries1. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- interval training, diet recommendations and mindfulness breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 12 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sixty Postmenopausal women (55-65 y)
- Body mass index (BMI) ranged from 35 to 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.
Egypt1 site, 1 recruiting
- Recruiting
Physical Therapy
Cairo, 11432
marwa m elsayed, Phd, 01156033818 ext. 02, marwadd999@gmail.com
About this study
Official title: High-intensity Interval Training and Mindfulness Breathing Induce Hormonal and Metabolic Effects and Alter Tumor Marker Levels in Obese Postmenopausal Women: A Randomized Controlled Trial
PURPOSE:
to determine the effect of interval training and mindfulness breathing on sex hormones, metabolic and tumor markers
Read more
BACKGROUND:
Cancer is one of death top causes in many countries1. In Egypt for example, cancer incidence is 157.0 per 100 000 women with probability increasing up to three-fold by 2050 especially in older adult women2. Who exhibit multiple factors leading to cancer including but not limited to physical inactivity and postmenopausal obesity which considered the starting point of developing insulin resistance3.
High blood insulin level stimulates cancer progression by enhancing cell proliferation, decreasing cells apoptosis, increased level of fatty acids in conjunction with higher tumor cell formation capacity invasion and survival4. Moreover, high level of insulin resistance and adipose tissue increase the hormonal level of estradiol and testosterone coupled with lower SHBG level.
It was noticed that being postmenopausal women with high adipose tissue content will increase the risk of having cancer in which adipose tissue is considered as the main source of steroids hormones that functioning in a different way rather than in premenopausal age. Based on the mentioned underlying conditions, postmenopausal women subjected to have variable types of cancer such as breast, endometrial, stomach, etc6.
So, regular screening of cancer incidence especially in high-risk women through tumor indicators is necessitated to work against further cancer progression. CEA and CA125 are low-cost tumor blood biomarkers used widely for early cancer identification, recurrence monitoring and follow up which linked to proinflammatory cytokines production
.
HYPOTHESES:
may have no effect to interval training and mindfulness breathing on sex hormones , metabolic and tumor markers in postmenopausal women
RESEARCH QUESTION:
Is there effect to interval training and mindfulness on sex hormones , metabolic and tumor markers in postmenopausal women?
Read the detailed description
HIIT group involved in an exercise program three times per week for three months in form of cycling protocol which will comprise 5 minutes warming up before exercise initiation and another 5 minutes for cooling down by the end of exercise session in form slow pedaling (50% of PHR). The work interval also will comprise 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program)17. Each work interval will be maintained at a range of 50-70 rpm (cycle revolutions) with a speed between 20 and 40 km/h. Exercise intensity will be ≥ 85% of peak heart rate (PHR) according to the Karvonen formula18.
which corresponds to 8-10 points on the modified Borg scale19. The exercise will be supervised along the first week only with guidance to ensure that each participant masters the optimal exercise procedure.
The participants will be equipped with a pulse oximeter for continuous monitoring of the heart rate prior to the start, during or just after the completion of the exercise session .Also, Mindful breathing is a exercise that involves using breathing as an object of attention. 15-minute mindful breathing intervention will be adapted. It consists of the following three steps: (a) adopt a physical posture, (b) establish a mindfulness anchor, and (c) maintain mindfulness . Healthy diet instructions will be recommended for those non-dietitian obese women without following specific diet programs that could influence our results.
- Conditions
- Insulin Resistance
- Being tested
- interval training, diet recommendations, mindfulness breathing
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interval trainingOther
Ixercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program).
diet recommendationsOther
the control group will follow diet recommendations for 12 weeks
mindfulness breathingOther
Mindful breathing is a exercise that involves using breathing as an object of attention. 15-minute mindful breathing intervention will be adapted. It consists of the following three steps: (a) adopt a physical posture, (b) establish a mindfulness anchor, and (c) maintain mindfulness
| Study group | Role | What they receive |
|---|---|---|
| study group will receive interval training and mindfulness breathing | Other | exercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program). Mindful breathing is a exercise that involves using breathing as an object of attention. 15-minute mindful breathing intervention will be adapted. It consists of the following three steps: (a) adopt a physical posture, (b) establish a mindfulness anchor, and (c) maintain mindfulness Receives: Other: interval training; Other: diet recommendations; Other: mindfulness breathing |
| diet recommendations | Other | The control group will receive diet recommendations. The volunteers will follow diet recommendations for 12 weeks Receives: Other: diet recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
insulin resistance will be measured by homeostasis model assessment (HOMA) index of change of insulin-resistance by homeostasis model assessment insulin resistance ( HOMA -IR )index
Measured: 12 weeks
sex hormones
change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'
Measured: 12 weeks
blood lipids
blood lipids will be measured by blood analysis,
Measured: 12 weeks
tumor markers
tumor markers will be measured by blood analysis,
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 posted15 Jul 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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, phd, Principal investigator, lecturer at physical therapy faculty cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471506
- Sponsor's protocol ID
- P.T.REC/012/004118
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2020
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Training and Mindfulness Breathing Induce Hormonal and Metabolic Effects and Alter Tumor Marker Levels in Obese Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04471506
- Acronym / sponsor ID
- P.T.REC/012/004118
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 15 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 interval training and mindfulness breathing on sex hormones, metabolic and tumor markers
BACKGROUND:
Cancer is one of death top causes in many countries1. In Egypt for example, cancer incidence is 157.0 per 100 000 women with probability increasing up to three-fold by 2050 especially in older adult women2. Who exhibit multiple factors leading to cancer including but not limited to physical inactivity and postmenopausal obesity which considered the starting point of developing insulin resistance3.
High blood insulin level stimulates cancer progression by enhancing cell proliferation, decreasing cells apoptosis, increased level of fatty acids in conjunction with higher tumor cell formation capacity invasion and survival4. Moreover, high level of insulin resistance and adipose tissue increase the hormonal level of estradiol and testosterone coupled with lower SHBG level.
It was noticed that being postmenopausal women with high adipose tissue content will increase the risk of having cancer in which adipose tissue is considered as the main source of steroids hormones that functioning in a different way rather than in premenopausal age. Based on the mentioned underlying conditions, postmenopausal women subjected to have variable types of cancer such as breast, endometrial, stomach, etc6.
So, regular screening of cancer incidence especially in high-risk women through tumor indicators is necessitated to work against further cancer progression. CEA and CA125 are low-cost tumor blood biomarkers used widely for early cancer identification, recurrence monitoring and follow up which linked to proinflammatory cytokines production
.
HYPOTHESES:
may have no effect to interval training and mindfulness breathing on sex hormones , metabolic and tumor markers in postmenopausal women
RESEARCH QUESTION:
Is there effect to interval training and mindfulness on sex hormones , metabolic and tumor markers in postmenopausal women?
Detailed description
HIIT group involved in an exercise program three times per week for three months in form of cycling protocol which will comprise 5 minutes warming up before exercise initiation and another 5 minutes for cooling down by the end of exercise session in form slow pedaling (50% of PHR). The work interval also will comprise 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program)17. Each work interval will be maintained at a range of 50-70 rpm (cycle revolutions) with a speed between 20 and 40 km/h. Exercise intensity will be ≥ 85% of peak heart rate (PHR) according to the Karvonen formula18.
which corresponds to 8-10 points on the modified Borg scale19. The exercise will be supervised along the first week only with guidance to ensure that each participant masters the optimal exercise procedure.
The participants will be equipped with a pulse oximeter for continuous monitoring of the heart rate prior to the start, during or just after the completion of the exercise session .Also, Mindful breathing is a exercise that involves using breathing as an object of attention. 15-minute mindful breathing intervention will be adapted. It consists of the following three steps: (a) adopt a physical posture, (b) establish a mindfulness anchor, and (c) maintain mindfulness . Healthy diet instructions will be recommended for those non-dietitian obese women without following specific diet programs that could influence our results.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group will receive interval training and mindfulness breathing | Other | Other: interval training, Other: diet recommendations, Other: mindfulness breathingexercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program). Mindful breathing is a exercise that involves using breathing as an object of attention. 15-minute mindful breathing intervention will be adapted. It consists of the following three steps: (a) adopt a physical posture, (b) establish a mindfulness anchor, and (c) maintain mindfulness |
| diet recommendations | Other | Other: diet recommendationsThe control group will receive diet recommendations. The volunteers will follow diet recommendations for 12 weeks |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sixty Postmenopausal women (55-65 y)
- Body mass index (BMI) ranged from 35 to 39.9 kg/m2
- Postmenopausal more than 2 years
Key exclusion criteria (9 listed)
- • women receiving weight-reduction interventions
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 |
|---|---|---|
| interval trainingIxercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program). | Other | study group will receive interval training and mindfulness breathing |
| diet recommendationsthe control group will follow diet recommendations for 12 weeks | Other | diet recommendations, study group will receive interval training and mindfulness breathing |
| mindfulness breathingMindful breathing is a exercise that involves using breathing as an object of attention. 15-minute mindful breathing intervention will be adapted. It consists of the following three steps: (a) adopt a physical posture, (b) establish a mindfulness anchor, and (c) maintain mindfulness | Other | study group will receive interval training and mindfulness breathing |
Primary outcome
insulin resistance
Time frame: 12 weeks
insulin resistance will be measured by homeostasis model assessment (HOMA) index of change of insulin-resistance by homeostasis model assessment insulin resistance ( HOMA -IR )index
sex hormones
Time frame: 12 weeks
change of sex hormones level (e.g. estradiol ,testosterone. sex hormone binding globin )'
blood lipids
Time frame: 12 weeks
blood lipids will be measured by blood analysis,
tumor markers
Time frame: 12 weeks
tumor markers will be measured by blood analysis,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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, phd principal investigator
lecturer at 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 interval training, diet recommendations and mindfulness breathing in people with Insulin Resistance, 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 3 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. 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 marwa m elsayed, phd (01156033818 ext. 02, marwadd999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin resistance (time frame: 12 weeks). The study lists 4 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 4 Sep 2024.