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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Marwa Mohamed

    Cairo

Other trials in Egypt

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 groups in NCT04708093
Study groupRoleWhat they receive
whole body vibration training (WBVT)Experimentalwhole body vibration group
Receives: Device: whole body vibration training
ControlledNo interventionadvised about healthy dieting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass index

    kg\m2

    Measured: after study completion through 3months

  2. serum prolactin concentration

    ng\ml

    Measured: after study completion through 3months

Secondary outcomes (1)
  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.

  1. First posted13 Jan 2021
  2. Study start1 Aug 2019
  3. Primary completion1 Aug 2020
  4. Study completion1 Sep 2020

Resources

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)
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

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.

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