Breast CancerNCT04708093
Whole Body Vibration Training and Breast Cancer Risk Factors
A study testing whole body vibration training in people with Breast Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
study aim is to determine the effect of whole body vibration training (WBVT) on body mass index, serum prolactin concentration as a risk factors for breast cancer and severity of hot flashes in obese postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- whole body vibration training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 Sep 2020
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- obese BMI ranged between 30-39.9 kg/m2.
- postmenopausal women
Who cannot join
- women with musculoskeletal or cardiovascular or neurological disorders
- hypothyroidism,
- polycystic ovary syndrome.
- chronic renal failure.
- participate in any exercise program prior to the study by six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole Body Vibration Training on Selected Breast Cancer Risk Factors in Obese Postmenopausal Women: A Randomized Controlled Trial
study aim is to determine the effect of whole body vibration training (WBVT) on body mass index, serum prolactin concentration as a risk factors for breast cancer and severity of hot flashes in obese postmenopausal women.
Read the detailed description
Menopause is a physiological process characterized by spontaneous cessation of menstrual cycle lasting at least 12 months, it is normally occurring in women aged 45 - 55 years . Postmenopausal women have higher prevalence of menopausal symptoms that significantly affect their quality of life more than pre- and perimenopausal women .
Increased adiposity, as measured by high body mass index, is associated with more severe menopausal symptoms also, obese female has a high risk lifestyle for the development of post-menopausal breast cancer .
The link between BMI and breast cancer risk is likely to be due to increased concentrations of bioavailable estradiol, which results in turn from an increase in the production of estrogens by aromatase in the adipose tissue, conversion of hormones in fatty tissue and a decrease in the serum concentration. This is likely to explain the higher risk of breast cancer in overweight post-menopausal women .
Menopause is also associated with atherogenic changes, including a worsening of CVD risk factors and decreased aerobic fitness compared with premenopausal women.
This initially may be due to a decrease in endogenous estrogen levels, and likely further exacerbated by increased adiposity and reductions in exercise habits or physical activity levels.
Post menopausal women recorded a high serum prolactin concentration however, they have a significant chance of normalizing their prolactin levels.
Serum prolactin levels rise transiently after several physiological states including pregnancy, breast-feeding, exercise, meals, sexual intercourse, minor surgical procedures, general anesthesia, other forms of acute stress and menopause.
Estrogen is another key regulator of prolactin and has been shown to increase the production and secretion of prolactin from the pituitary gland. In addition to dopamine and estrogen, a whole range of other hormones can both increase and decrease the amount of prolactin released in the body, with some examples being thyrotropin-releasing hormone, oxytocin and anti-diuretic hormone .
Whole-body vibration training is a promising adjunct intervention therapy for management of obesity, as there is few evidence that it can reduces body mass index and enhances muscles strength.
In initial stage of obesity management, WBVT is highly recommended because it allows a mild joints stress, deconditioning for obese patient with poor motivation because it achieve its target without provoking an excessive fatigue. In addition, Passive vibrations do not involve voluntary movement and need a lower contribution of central command, so WBVT is as effective as aerobic and resistance exercise in reducing fat mass and moderating the deficit of the relative muscle strength . Lastly, WBVT may be effective in vascular health promotion and prevention in young obese women.
Whole body vibration training(WBVT) has been recognized as an effective alternative exercise modality to resistance exercise for its ability in enhancing force and power, generating capacity in skeletal muscle, increasing bone mass, improving cardiovascular function, reducing fat mass and moderating the deficit of the relative muscle strength. Unfortunately, the effect of resistance exercise on prolactin has not been extensively studied .
So, this study was conducted to evaluate the effect of whole body vibration training on BMI, waist circumference, serum prolactin concentration and hot flashes in obese postmenopausal women.
- Conditions
- Breast Cancer
- Being tested
- whole body vibration training
- Keywords
- Breast Cancer, Hot Flashes, Prolactin, Whole Body Vibration
- Medical subject headings
- Breast Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration trainingDevice
Also called (WBVT)
Oscillating platform
| Study group | Role | What they receive |
|---|---|---|
| whole body vibration training (WBVT) | Experimental | whole body vibration group Receives: Device: whole body vibration training |
| Controlled | No intervention | advised about healthy dieting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
kg\m2
Measured: after study completion through 3months
serum prolactin concentration
ng\ml
Measured: after study completion through 3months
Secondary outcomes (1)
hot flashes
severity
Measured: after study completion through 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Aug 2019
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Model description
- prospective study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa A. Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708093
- Sponsor's protocol ID
- Woman health
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration Training on Selected Breast Cancer Risk Factors in Obese Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04708093
- Acronym / sponsor ID
- Woman health
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Hot Flashes, Prolactin, Whole Body Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 13 Jan 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.
study aim is to determine the effect of whole body vibration training (WBVT) on body mass index, serum prolactin concentration as a risk factors for breast cancer and severity of hot flashes in obese postmenopausal women.
Detailed description
Menopause is a physiological process characterized by spontaneous cessation of menstrual cycle lasting at least 12 months, it is normally occurring in women aged 45 - 55 years . Postmenopausal women have higher prevalence of menopausal symptoms that significantly affect their quality of life more than pre- and perimenopausal women .
Increased adiposity, as measured by high body mass index, is associated with more severe menopausal symptoms also, obese female has a high risk lifestyle for the development of post-menopausal breast cancer .
The link between BMI and breast cancer risk is likely to be due to increased concentrations of bioavailable estradiol, which results in turn from an increase in the production of estrogens by aromatase in the adipose tissue, conversion of hormones in fatty tissue and a decrease in the serum concentration. This is likely to explain the higher risk of breast cancer in overweight post-menopausal women .
Menopause is also associated with atherogenic changes, including a worsening of CVD risk factors and decreased aerobic fitness compared with premenopausal women.
This initially may be due to a decrease in endogenous estrogen levels, and likely further exacerbated by increased adiposity and reductions in exercise habits or physical activity levels.
Post menopausal women recorded a high serum prolactin concentration however, they have a significant chance of normalizing their prolactin levels.
Serum prolactin levels rise transiently after several physiological states including pregnancy, breast-feeding, exercise, meals, sexual intercourse, minor surgical procedures, general anesthesia, other forms of acute stress and menopause.
Estrogen is another key regulator of prolactin and has been shown to increase the production and secretion of prolactin from the pituitary gland. In addition to dopamine and estrogen, a whole range of other hormones can both increase and decrease the amount of prolactin released in the body, with some examples being thyrotropin-releasing hormone, oxytocin and anti-diuretic hormone .
Whole-body vibration training is a promising adjunct intervention therapy for management of obesity, as there is few evidence that it can reduces body mass index and enhances muscles strength.
In initial stage of obesity management, WBVT is highly recommended because it allows a mild joints stress, deconditioning for obese patient with poor motivation because it achieve its target without provoking an excessive fatigue. In addition, Passive vibrations do not involve voluntary movement and need a lower contribution of central command, so WBVT is as effective as aerobic and resistance exercise in reducing fat mass and moderating the deficit of the relative muscle strength . Lastly, WBVT may be effective in vascular health promotion and prevention in young obese women.
Whole body vibration training(WBVT) has been recognized as an effective alternative exercise modality to resistance exercise for its ability in enhancing force and power, generating capacity in skeletal muscle, increasing bone mass, improving cardiovascular function, reducing fat mass and moderating the deficit of the relative muscle strength. Unfortunately, the effect of resistance exercise on prolactin has not been extensively studied .
So, this study was conducted to evaluate the effect of whole body vibration training on BMI, waist circumference, serum prolactin concentration and hot flashes in obese postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective study
| Arm | Type | Receives |
|---|---|---|
| whole body vibration training (WBVT) | Experimental | Device: whole body vibration trainingwhole body vibration group |
| Controlled | No intervention | –advised about healthy dieting |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obese BMI ranged between 30-39.9 kg/m2.
- postmenopausal women
Key exclusion criteria (5 listed)
- women with musculoskeletal or cardiovascular or neurological disorders
- hypothyroidism,
- polycystic ovary syndrome.
- chronic renal failure.
- participate in any exercise program prior to the study by six months.
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 |
|---|---|---|
| whole body vibration trainingAlso: (WBVT)Oscillating platform | Device | whole body vibration training (WBVT) |
Primary outcome
Body mass index
Time frame: after study completion through 3months
kg\m2
serum prolactin concentration
Time frame: after study completion through 3months
ng\ml
1 secondary outcome
hot flashes
Time frame: after study completion through 3months
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 13 Jan 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration training in people with Breast Cancer, 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 13 Jan 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?
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?
Body mass index (time frame: after study completion through 3months). 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 13 Jan 2021.