NCT03865368

Brief Summary

Whole Body Vibration Therapy (WBVT) has been identified as a useful tool to increase peripheral blood flow. The present study aimed at how dynamic exercises with WBVT immediate effect on hemodynamic response and fatigue parameters in patients with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

February 27, 2019

Last Update Submit

March 5, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    Heart rate was evaluated from the brachial artery using a sphygmanometer.

    "20 minute"

  • Blood pressure

    Blood pressure was evaluated using a sphygmomanometer.

    "20 minute"

Secondary Outcomes (1)

  • Fatigue

    "20 minute"

Other Outcomes (1)

  • Change in Dyspnea

    "20 minute"

Study Arms (2)

Active Whole Body Vibration Training

EXPERIMENTAL

Exercises were taught during the first session, active training was done in the second session, and acute evaluations were made during the third session. Both groups performed the dynamic exercises, under supervision, on the whole body vibration device with 10-second rest intervals. Throughout the WBVT session, the vibration amplitude was set to 2 mm and exercise frequency 30 Hz.

Other: Whole Body Vibration Training

Control Group

ACTIVE COMPARATOR

The same exercises as the aWBVT group were performed on the vibration platform, with the vibration application turned off

Other: Whole Body Vibration Training

Interventions

Whole Body Vibration Training (WBVT) method has been used as an alternative to conventional strengthening exercises. In this method, the patient stands on the platform of the WBVT device in a static position or performs dynamic exercises, the mechanical vibration produced by the device is transferred to the body

Also known as: Standard Exercise
Active Whole Body Vibration TrainingControl Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals between age 18-65 with Body Mass Index (BMI) of \>29.9 kg/m2

You may not qualify if:

  • Unstable hypertensive patients
  • History of cardiovascular, neurologic, or orthopedic diseases,
  • Presence of knee prosthesis, hip replacement
  • Chronic inflammatory disease,
  • Anti-inflammatory treatment
  • Cognitive impairments
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Okan University Sports Laboratory

Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor was blinded.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Active Whole Body Vibration (aWBVT) group, performed ten dynamic standard exercises on a vibration platform. The vibration protocol lasted for 15 minutes, in a frequency of 30 Hz and amplitude of 2 mm. Control group performed only ten dynamic standard exercises with no vibration application. Blood Pressure, heart rate, saturated oxygen were measured for the hemodynamic response. Modified Borg Dyspnoea Scale (MBDS) and The Borg Rating of Perceived Exertion (BRPE) Scale were used in order to evaluate fatigue level. All evaluations were performed at the beginning of the study, at the end of the session and at the recovery period
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 6, 2019

Study Start

November 1, 2018

Primary Completion

February 15, 2019

Study Completion

February 27, 2019

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations