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Whole-body Vibration Training in Older People (GERIAPLAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asociacion Colaboracion Cochrane Iberoamericana
ClinicalTrials.gov Identifier:
NCT01375790
First received: June 16, 2011
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Aging
 Device: Exercise with Whole-body vibration platform
Other: Exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromuscular Training With Whole Body Vibration in Older People: A Randomized Multicentre Clinical Trial With Blinded to Evaluator

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asociacion Colaboracion Cochrane Iberoamericana:

Primary Outcome Measures:
  • Body balance. [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
    Body balance will be evaluated using Tinetti Test, and Timed up and go test


Secondary Outcome Measures:
  • Body balance [ Time Frame: at six months ] [ Designated as safety issue: No ]
    Body balance will be evaluated using Tinetti Test, and Timed up and go test

  • Muscle performance [ Time Frame: at 6 weeks, and 6 months ] [ Designated as safety issue: No ]
    It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.

  • Number of falls [ Time Frame: during 6 months ] [ Designated as safety issue: No ]
    Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.

  • Safety of interventions [ Time Frame: During 6 months ] [ Designated as safety issue: Yes ]
    Pain, headache, itching or soreness on the legs, erythema.


Enrollment: 160
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Balance and resistance training

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375790

Locations
Spain
Albada Centre Socio Sanitari Parc Taulí
Sabadell, Babadell, Spain, 08208
Ballesol Badalona
Badalona, Barcelona, Spain, 08911
Ballesol Barberà
Barberà del Vallès, Barcelona, Spain, 08210
Residència Allegra
Sabadell, Barcelona, Spain, 08203
Residència Collserola (Mutuam)
Barcelona, Spain, 08035
Ballesol Fabra i Puig
Barcelona, Spain, 08016
Residència Mapfre Quavitae
Barcelona, Spain, 08025
Residència Poble Nou
Barcelona, Spain, 08005
Residència AMMA Horta
Barcelona, Spain, 08035
Ballesol Almogàvers
Barcelona, Spain, 08018
Sponsors and Collaborators
Asociacion Colaboracion Cochrane Iberoamericana
Investigators
Principal Investigator: Mercè Sitjà Rabert, PhD • Health Sciences Faculty Blanquerna (Universitat Ramon Llull)
  More Information

No publications provided by Asociacion Colaboracion Cochrane Iberoamericana

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Asociacion Colaboracion Cochrane Iberoamericana
ClinicalTrials.gov Identifier: NCT01375790     History of Changes
Other Study ID Numbers: GERIAPLAT/1, PI/180-2010
Study First Received: June 16, 2011
Last Updated: August 28, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Asociacion Colaboracion Cochrane Iberoamericana:
whole-body vibration
older people
exercise
body balance
 muscle performance
falls
physiotherapy

ClinicalTrials.gov processed this record on May 19, 2013