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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

June 16, 2011
August 28, 2012
November 2010
September 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01375790 on ClinicalTrials.gov Archive Site
  • 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.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Sitjà-Rabert M, Martínez-Zapata MJ, Fort-Vanmeerhaeghe A, Rey-Abella F, Romero-Rodríguez D, Bonfill X. Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial. BMC Geriatr. 2011 Dec 22;11:89.

*   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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01375790
GERIAPLAT/1, PI/180-2010
No
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