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Whole-body Vibration Training in Older People (GERIAPLAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01375790
First Posted: June 17, 2011
Last Update Posted: August 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asociacion Colaboracion Cochrane Iberoamericana
June 16, 2011
June 17, 2011
August 29, 2012
November 2010
September 2011   (Final data collection date for primary outcome measure)
Body balance. [ Time Frame: at 6 weeks ]
Body balance will be evaluated using Tinetti Test, and Timed up and go test
Same as current
Complete list of historical versions of study NCT01375790 on ClinicalTrials.gov Archive Site
  • Body balance [ Time Frame: at six months ]
    Body balance will be evaluated using Tinetti Test, and Timed up and go test
  • Muscle performance [ Time Frame: at 6 weeks, and 6 months ]
    It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.
  • 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.
  • Safety of interventions [ Time Frame: During 6 months ]
    Pain, headache, itching or soreness on the legs, erythema.
Same as current
Not Provided
Not Provided
 
Whole-body Vibration Training in Older People
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Aging
  • 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
  • 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
  • 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.
    Intervention: Device: Exercise with 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
    Intervention: Other: Exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
March 2012
September 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01375790
GERIAPLAT/1
PI/180-2010 ( Other Grant/Funding Number: IMSERSO )
No
Not Provided
Not Provided
Asociacion Colaboracion Cochrane Iberoamericana
Asociacion Colaboracion Cochrane Iberoamericana
Not Provided
Principal Investigator: Mercè Sitjà Rabert, PhD • Health Sciences Faculty Blanquerna (Universitat Ramon Llull)
Asociacion Colaboracion Cochrane Iberoamericana
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP