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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03180814
Other study ID # WBV on autonomic function
Secondary ID
Status Completed
Phase N/A
First received March 21, 2017
Last updated December 29, 2017
Start date July 31, 2017
Est. completion date December 30, 2017

Study information

Verified date December 2017
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 30, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Whole Body Vibration
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.

Locations

Country Name City State
Brazil Federal University of Pernambuco Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Sympathetic modulation Sympathetic modulation will be assessed from 3-channel holter Change from Baseline Sympathetic modulation at 5, 10, 15, 20 and 35 minutes
Secondary Parasympathetic modulation Parasympathetic modulation will be assessed from 3-channel holter Change from Baseline Parasympathetic modulation at 5, 10, 15, 20 and 35 minutes
Secondary Sympathovagal Balance Sympathovagal Balance will be assessed from 3-channel holter Change from Baseline Sympathovagal balance at 5, 10, 15, 20 and 35 minutes
Secondary Heart Rate Non-invasive measures will be assessed from 3-channel holter Change from Baseline Heart Rate at 5, 10, 15, 20 and 35 minutes
Secondary Blood pressure Non-invasive measures of brachial blood pressure Change from Baseline Blood pressure at 5, 10, 15, 20 and 35 minutes
Secondary Peripheral oxygen saturation Non-invasive measures will be assessed from pulse oximeter Change from Baseline Peripheral oxygen saturation at 5, 10, 15, 20 and 35 minutes
Secondary Adverse effects Adverse effects reported by volunteers Change from Baseline at 20 minutes
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