NCT04708093

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

January 8, 2021

Last Update Submit

January 11, 2021

Conditions

Breast Cancer

Keywords

Breast CancerHot FlashesProlactinWhole Body Vibration

Outcome Measures

Primary Outcomes (2)

  • Body mass index

    kg\\m2

    after study completion through 3months

  • serum prolactin concentration

    ng\\ml

    after study completion through 3months

Secondary Outcomes (1)

  • hot flashes

    after study completion through 3months

Study Arms (2)

whole body vibration training (WBVT)

EXPERIMENTAL

whole body vibration group

Device: whole body vibration training

Controlled

NO INTERVENTION

advised about healthy dieting

Interventions

whole body vibration trainingDEVICE

Oscillating platform

Also known as: (WBVT)
whole body vibration training (WBVT)

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspost menopausal female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Breast NeoplasmsHot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 13, 2021

Study Start

August 1, 2019

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)