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).
Investigators
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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