Whole-body Vibration Training in Older People (GERIAPLAT)

August 28, 2012 updated by: Asociacion Colaboracion Cochrane Iberoamericana

Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator

This is a randomized, multicentre, and parallel clinical trial with blinded to evaluator.

The principal hypothesis is that whole-body vibration training plus exercise improves the body balance and prevents falls more than only exercise training in institutionalized older people. The number needed of patients is 160 (80 per group).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08005
        • Residència Poble Nou
      • Barcelona, Spain, 08016
        • Ballesol Fabra i Puig
      • Barcelona, Spain, 08018
        • Ballesol Almogàvers
      • Barcelona, Spain, 08025
        • Residència Mapfre Quavitae
      • Barcelona, Spain, 08035
        • Residència AMMA Horta
      • Barcelona, Spain, 08035
        • Residència Collserola (Mutuam)
    • Babadell
      • Sabadell, Babadell, Spain, 08208
        • Albada Centre Socio Sanitari Parc Taulí
    • Barcelona
      • Badalona, Barcelona, Spain, 08911
        • Ballesol Badalona
      • Barberà del Vallès, Barcelona, Spain, 08210
        • Ballesol Barberà
      • Sabadell, Barcelona, Spain, 08203
        • Residència Allegra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Institutionalized older people who were 65 years and older
  • The patient consent to participate in the study

Exclusion Criteria:

  • Residents who present an acute disease that not resolved during 10 days.
  • Residents with a pacemaker (or serious cardiac alterations)
  • Residents with epilepsy
  • Residents with a high risk of thromboembolism
  • Residents with a history of a hip or knee joint replacement
  • Residents who not were musculoskeletal disorders and cognitive or physical dysfunction that interfering with test and training procedures.
  • Residents that not accept to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise with Whole-body vibration platform
Exercise with Whole-body vibration (WBV) platform (Power Plate®). The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm). Training volume and intensity we will increase systematically over six weeks according to the overload principle.
Device: Exercise with Whole-body vibration platform
The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm).
Other Names:
  • Power Plate® Whole-body vibration platform
Active Comparator: Exercise
The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli, during a six weeks training period (3sessions/week). Training volume and intensity we will increase systematically over six weeks according to the overload principle
Other: Exercise
The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli.
Other Names:
  • Balance and resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body balance.
Time Frame: at 6 weeks
Body balance will be evaluated using Tinetti Test, and Timed up and go test
at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body balance
Time Frame: at six months
Body balance will be evaluated using Tinetti Test, and Timed up and go test
at six months
Muscle performance
Time Frame: at 6 weeks, and 6 months
It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.
at 6 weeks, and 6 months
Number of falls
Time Frame: during 6 months
Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.
during 6 months
Safety of interventions
Time Frame: During 6 months
Pain, headache, itching or soreness on the legs, erythema.
During 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociacion Colaboracion Cochrane Iberoamericana

Investigators

  • Principal Investigator: Mercè Sitjà Rabert, PhD, • Health Sciences Faculty Blanquerna (Universitat Ramon Llull)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2012

Last Update Submitted That Met QC Criteria

August 28, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GERIAPLAT/1
  • PI/180-2010 (Other Grant/Funding Number: IMSERSO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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