Whole-body Vibration Training in Older People

Aging Clinical Trial

— GERIAPLAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375790
• Other study ID #: GERIAPLAT/1
• Secondary ID: PI/180-2010
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2011
• Last updated: August 28, 2012
• Start date: November 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Asociacion Colaboracion Cochrane Iberoamericana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

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:
• Exercise
The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli.

Locations

Country	Name	City	State
Spain	Ballesol Badalona	Badalona	Barcelona
Spain	Ballesol Barberà	Barberà del Vallès	Barcelona
Spain	Ballesol Almogàvers	Barcelona
Spain	Ballesol Fabra i Puig	Barcelona
Spain	Residència AMMA Horta	Barcelona
Spain	Residència Collserola (Mutuam)	Barcelona
Spain	Residència Mapfre Quavitae	Barcelona
Spain	Residència Poble Nou	Barcelona
Spain	Albada Centre Socio Sanitari Parc Taulí	Sabadell	Babadell
Spain	Residència Allegra	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion Colaboracion Cochrane Iberoamericana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body balance.	Body balance will be evaluated using Tinetti Test, and Timed up and go test	at 6 weeks	No
Secondary	Body balance	Body balance will be evaluated using Tinetti Test, and Timed up and go test	at six months	No
Secondary	Muscle performance	It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.	at 6 weeks, and 6 months	No
Secondary	Number of falls	Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.	during 6 months	No
Secondary	Safety of interventions	Pain, headache, itching or soreness on the legs, erythema.	During 6 months	Yes