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Clinical Trials/NCT01375790
NCT01375790
Completed
Phase 3

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

Asociacion Colaboracion Cochrane Iberoamericana10 sites in 1 country160 target enrollmentNovember 2010
ConditionsAging

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Aging
Sponsor
Asociacion Colaboracion Cochrane Iberoamericana
Enrollment
160
Locations
10
Primary Endpoint
Body balance.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Asociacion Colaboracion Cochrane Iberoamericana
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Body balance.

Time Frame: at 6 weeks

Body balance will be evaluated using Tinetti Test, and Timed up and go test

Secondary Outcomes

  • Body balance(at six months)
  • Muscle performance(at 6 weeks, and 6 months)
  • Number of falls(during 6 months)
  • Safety of interventions(During 6 months)

Study Sites (10)

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