NCT02679898

Brief Summary

Obesity is directly related to arterial dysfunction and negatively associated to muscle strength. High-intensity resistance exercise is the favored modality to offset muscle weakness, yet, adverse effects on arterial function (pulse wave velocity, wave reflection, and aortic and brachial blood pressures) have been observed. Conventional unloaded-whole body vibration training (WBVT) has improved arterial function in overweight/obese women but appears to be low-intensity. Nevertheless, the effects of moderate-intensity (by adding external load) WBVT on arterial and muscle function are unknown. Therefore, the purpose of this study was to examine whether loaded-WBVT would induce greater benefits than unloaded-WBVT on arterial and muscle function in young overweight/obese women. Furthermore, we examined whether these changes were similar to healthy lean young women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

February 1, 2016

Last Update Submit

February 8, 2016

Conditions

Keywords

Arterial functionWhole-body vibration trainingAortic blood pressuresWave reflectionMuscle strengthEndothelial functionBlood flow

Outcome Measures

Primary Outcomes (2)

  • Arterial Stiffness

    Aortic, leg, and systemic pulse wave velocity acquired through non-invasive sensors.

    6 weeks

  • Pressure Wave Reflection

    Augmentation index acquired through radial tonometry.

    6 weeks

Secondary Outcomes (5)

  • Body Composition

    6 weeks

  • Muscle Strength

    6 weeks

  • Autonomic Function

    6 weeks

  • Blood Pressures

    6 weeks

  • Endothelial Function

    6 weeks

Study Arms (4)

Lean Control

NO INTERVENTION

This arm involves not making any changes to the subject's lifestyle at the moment of the start of the intervention and for 6 weeks.

Overweight/Obese Control

NO INTERVENTION

This arm involves not making any changes to the subject's lifestyle at the moment of the start of the intervention and for 6 weeks.

Unloaded-Whole Body Vibration (WBVT)

EXPERIMENTAL

Lower-body exercise training on a vibration platform

Other: Unloaded-Whole Body Vibration (WBVT)

Loaded-Whole Body Vibration (WBVT)

EXPERIMENTAL

Externally loaded lower-body exercise training on a vibration platform

Other: Loaded-Whole Body Vibration (WBVT)

Interventions

The unloaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec).

Unloaded-Whole Body Vibration (WBVT)

The loaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Importantly, an external load was applied to a weight vest to account for the necessary weight to perform a specific number of repetitions (progressed from 15-8 repetitions maximum during the 6 weeks). Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec).

Loaded-Whole Body Vibration (WBVT)

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • to 25 years of age
  • Sedentary (less than 120 min per wk)
  • lean (Body mass index of 18-25 kg/m²)
  • overweight/obese (Body mass index of 27-39.9 kg/m²)

You may not qualify if:

  • Younger than 18 or older than 25 years of age
  • Body mass index lower than 18 or higher than 39.9
  • Physically active or competitively active
  • Smokers
  • Pregnant
  • Irregular menstrual cycle
  • Use of dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants)
  • Any contraindications to exercise and/or whole-body vibration exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSU College of Human Sciences

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

  • Alvarez-Alvarado S, Jaime SJ, Ormsbee MJ, Campbell JC, Post J, Pacilio J, Figueroa A. Benefits of whole-body vibration training on arterial function and muscle strength in young overweight/obese women. Hypertens Res. 2017 May;40(5):487-492. doi: 10.1038/hr.2016.178. Epub 2017 Jan 12.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Arturo Figueroa

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 11, 2016

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations