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Completed

NCT Number: NCT01375790

Whole-body Vibration Training in Older People

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).

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Key information

Conditions

Aging Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Albada Centre Socio Sanitari Parc Taulí, Sabadell, Babadell, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise with Whole-body vibration platform

Device

The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm).

Other names: Power Plate® Whole-body vibration platform

Exercise

Other

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

Other names: Balance and resistance training

Primary outcomes

  1. Body balance.

    Time frame: at 6 weeks

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

Secondary outcomes

  1. Body balance

    Time frame: at six months

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

  2. Muscle performance

    Time frame: at 6 weeks, and 6 months

    It will be evaluated by five-sit-to-stand test, and Smartcoach Encoder.

  3. Number of falls

    Time frame: during 6 months

    Fall: an unexpected event in which the participants come to rest on the ground, floor, or lower level.

  4. Safety of interventions

    Time frame: During 6 months

    Pain, headache, itching or soreness on the legs, erythema.

Sponsors and collaborators

Lead sponsor

Asociacion Colaboracion Cochrane Iberoamericana

Other

Registry information

Official study title

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

Acronym: GERIAPLAT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 17, 2011
Registry last updated
Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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