Whole Body Vibration Training and Breast Cancer Risk Factors

January 11, 2021 updated by: Marwa A. Mohamed, Cairo University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Marwa Mohamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • obese BMI ranged between 30-39.9 kg/m2.
  • postmenopausal women

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: whole body vibration training (WBVT)
whole body vibration group
Device: whole body vibration training
Oscillating platform
Other Names:
  • (WBVT)
No Intervention: Controlled
advised about healthy dieting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: after study completion through 3months
kg\m2
after study completion through 3months
serum prolactin concentration
Time Frame: after study completion through 3months
ng\ml
after study completion through 3months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hot flashes
Time Frame: after study completion through 3months
severity
after study completion through 3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Woman health

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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