Whole-body Vibration Training in Older People

Phase 3

Completed

• Conditions: Aging
• Interventions: Device: Exercise with Whole-body vibration platform; Other: Exercise

• Registration Number: NCT01375790
• Lead Sponsor: Asociacion Colaboracion Cochrane Iberoamericana

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-28
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise with Whole-body vibration platform	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.
Exercise	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

Primary Outcome Measures

Name	Time	Method
Body balance.	at 6 weeks	Body balance will be evaluated using Tinetti Test, and Timed up and go test

Secondary Outcome Measures

Name	Time	Method
Body balance	at six months	Body balance will be evaluated using Tinetti Test, and Timed up and go test
Muscle performance	at 6 weeks, and 6 months	It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.
Number of falls	during 6 months	Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.
Safety of interventions	During 6 months	Pain, headache, itching or soreness on the legs, erythema.

Trial Locations

Locations (10)

Residència AMMA Horta; 🇪🇸 Barcelona, Spain

Residència Poble Nou; 🇪🇸 Barcelona, Spain

Albada Centre Socio Sanitari Parc Taulí; 🇪🇸 Sabadell, Babadell, Spain

Ballesol Almogàvers; 🇪🇸 Barcelona, Spain

Residència Mapfre Quavitae; 🇪🇸 Barcelona, Spain

Residència Collserola (Mutuam); 🇪🇸 Barcelona, Spain

Ballesol Badalona; 🇪🇸 Badalona, Barcelona, Spain

Ballesol Barberà; 🇪🇸 Barberà del Vallès, Barcelona, Spain

Ballesol Fabra i Puig; 🇪🇸 Barcelona, Spain

Residència Allegra; 🇪🇸 Sabadell, Barcelona, Spain