NCT03030456

Brief Summary

This study is a randomized clinical trial that has as objective to evaluate the effects of training with a vibratory platform on body composition, muscular strength functional capacity, flexibility and biochemical profile on elderly women. It will be done in the city of Santa Cruz do Sul, Rio Grande do Sul, with elderly women between the ages of 60 and 80 years-old, within the municipal limits and nearby areas selected randomly by a brown envelope in which a note will be stating if they belong to the control or vibratory platform group, in which the participant will be receiving whole body vibrations on the platform. The recruiting will be done by the institution through e-mail or by public call. Women will be evaluated through anamesis. On the evaluation, a questionaire will be applied, in order to evaluate if they don´t have counterindications for the vibratory platform. They will be evaluated in their general health, socio-economical status, and history of physical activity. Participants will have their doubts cleared about the study, and a written consent will be signed. Before the intervention with whole body vibrations, nutritional and physical activity aspects will be evaluated. The treatment period on the vibratory platform will be of 8 weeks, before and after it, anthropometrical, biochemical, strength, flexibility, palmar prehension strength, metabolic basal load, and functional capacity measurements will be taken. Before and after every session on the vibratory platform, heart rate, respiratory rate, arterial pressure, and peripheric oxygen saturation will be evaluated. The interventional procedure will be done with a vibratory platform (Power Plate®, model my7™, UK) with a frequency of 30 - 40 Hz, with low (2mm) or high (4mm) amplitude. Training will last 8 weeks with 3 sessions per week, lasting between 30 seconds and 1 minute of training, and 30 seconds to 1 minute of rest, with the subject positioned in orthosis with a knee flexion of 15° and a feet width distance of 20 cm. The frequency will be of 35 Hz and the amplitude of 2 mm. The study aims to contribute with reducing the body mass index and body fat percentage, to improve the lean mass, palmar prehension strength, muscular strength on the lower limbs and flexibility, also obtaining better biochemical profiles after the training period.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
unknown

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, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

September 21, 2016

Last Update Submit

January 20, 2017

Conditions

Keywords

whole body vibrationOxidative StressAgedBiochemical profilemuscle strengthflexibility

Outcome Measures

Primary Outcomes (3)

  • Effects of whole body vibrations training on Functional Capacity in Elderly Women.

    Functional Capacity will be measured through distance traveled with the six minute walk test.

    eight weeks

  • Effects of whole body vibrations training on Muscle Strength in Elderly Women.

    Muscular strength will be measured by the maximum repetitions test.

    eight weeks

  • Effects of whole body vibrations training on Biochemical Profile in Elderly Women.

    Biochemical profile will be measured through blood collection and there will be a result (number) for each one of the following variables: hemogram, glycemia, cholesterol, triglycerides, Urea, creatine, uric acid. Oxidative stress will be measured through TBARS test, which will present a numerical result.

    eight weeks

Study Arms (2)

Control Group

NO INTERVENTION

Elderly women receiving a list of general health orientations through an 8 week period

Power Plate®

EXPERIMENTAL

Power Plate®: training of elderly women

Device: Power Plate®

Interventions

Training of elderly women with Whole Body Vibrations through the use of a vibratory platform.

Also known as: Whole Body Vibrations
Power Plate®

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female aged 60 or older.
  • Non-physical activity practicing elderly women.
  • Maximum weight of 159 kg.
  • BMI between 18 and 39 kg/m².

You may not qualify if:

  • Systemic arterial hypertension, (systolic arterial pressure \>140 mmHg or diastolic arterial pressure \>90 mmHg).
  • Cognitive compromising neutropenia.
  • Individual subject to surgical procedures, where bone prosthetics has been implanted or cardiac pacemaker.
  • Individuals diagnosed with labyrinthitis, disc hernia, thrombosis,decompensated diabetes or cancer.
  • Cognitive deficit.
  • Orthopedic deficit which makes participation impossible.
  • Persistent discomfort after using the vibratory platform.
  • Individuals missing three consecutive training sessions on the vibratory platform.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Greice Raquel Machado

    Masters Student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHYSICAL THERAPIST

Study Record Dates

First Submitted

September 21, 2016

First Posted

January 25, 2017

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share