NCT03180814

Brief Summary

Aging causes anatomical and physiological changes in the cardiovascular system and autonomic function with decline in its maximum function. This study aimed to evaluate the acute effects of whole body vibration on cardiovascular system, autonomic function and heart variability in healthy young and elderly. The investigators' hypothesis is that whole body vibration has different effects in young and elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

March 21, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

1 month

First QC Date

March 21, 2017

Last Update Submit

December 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Autonomic Function

    Heart rate variability will be assessed from 3-channel holter

    Change from Baseline Heart rate variability at 5, 10, 15, 20 and 35 minutes

Secondary Outcomes (7)

  • Sympathetic modulation

    Change from Baseline Sympathetic modulation at 5, 10, 15, 20 and 35 minutes

  • Parasympathetic modulation

    Change from Baseline Parasympathetic modulation at 5, 10, 15, 20 and 35 minutes

  • Sympathovagal Balance

    Change from Baseline Sympathovagal balance at 5, 10, 15, 20 and 35 minutes

  • Heart Rate

    Change from Baseline Heart Rate at 5, 10, 15, 20 and 35 minutes

  • Blood pressure

    Change from Baseline Blood pressure at 5, 10, 15, 20 and 35 minutes

  • +2 more secondary outcomes

Study Arms (2)

Young Group

ACTIVE COMPARATOR

Healthy young of both sexes between the ages of 18 and 30 years will perform a whole body vibration session

Other: Whole Body Vibration

Elderly Group

EXPERIMENTAL

Healthy elderly of both sexes between the ages of 60 and 80 years will perform a whole body vibration session

Other: Whole Body Vibration

Interventions

A whole body vibration session will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 04 mm.

Elderly GroupYoung Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly individuals aged between 60 and 80 years
  • Young individuals aged between 18 and 30 years
  • Able to walk without assistance
  • Good understanding to perform the proposed procedures
  • Sedentary or low active

You may not qualify if:

  • Body Mass Index (BMI) \> 35Kg/m2
  • Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg (at rest)
  • Difficulty adapting to the whole body vibration
  • Smoking
  • Neuromuscular or degenerative disorders
  • Neurological diseases
  • Cardiopulmonary comorbidities
  • Cardiac arrhythmias
  • Osteoarticular disorders
  • Use of hormone replacement therapy
  • Use medications or supplements known to affect cardiovascular parameters
  • Labyrinthitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

March 21, 2017

First Posted

June 8, 2017

Study Start

July 31, 2017

Primary Completion

August 31, 2017

Study Completion

December 30, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations