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Effects of Whole-body Vibration in the Frail Elderly

L

Li Zhang

Status

Unknown

Conditions

Osteoporosis
Sarcopenia;

Treatments

Procedure: WBV training
Procedure: PRT training

Study type

Interventional

Funder types

Other

Identifiers

NCT02090192
ChinaPLAGH-2013FC3009

Details and patient eligibility

About

Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients.

Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried Frailty Criteria.

Interventions: All eligible subjects were randomly assigned to 4 groups:

(1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+ PRT group: Subjects received the whole-body vibration and progressive resistance training; (4) Control group: Subjects received no intervention/training. The periods of intervention are 12 weeks.

Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of the common femoral artery), timed up and go test, 30-second chair stand test, five times sit to stand test, lower extremities muscle strength, balance function, balance confidence, bone density, and general health status was assessed at the beginning of the study, at instant, 12 weeks and 24 month after the intervention.

Study hypothesis: Whole-body vibration exercise is a safe and effective method that can improve the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status in the frail elderly.

Enrollment

160 estimated patients

Sex

All

Ages

75+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • ≥75 years old
  • Fried Frailty Criteria
  • Mini Mental State Examination score ≥18

Exclusion criteria

  • Recent fractures (≤6 months)
  • Gallbladder or kidney stones
  • Malignancies
  • Rheumatic arthritis
  • Epilepsy
  • Serious heart sicknesses or an implant, and bypass stent or cardiac pacemaker
  • Any diseases to be associated with a life expectancy of less than 12 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 4 patient groups, including a placebo group

WBV training
Experimental group
Description:
Whole-body vibration training was performed on a commercial Galileo machine (Germany). Participants were required to stand on the moveable rectangular platform and positioned their feet at an equal and standardized distance from the axis of rotation so that the vertical vibration amplitude was 1-3 mm. The frequency was set at 6-26 Hz. The vibration protocol consisted of four to five bouts (60 seconds for each bout), and three to five times a week for 12 weeks. The positions taken by the subjects differed according to their function. Participants who could stand independently were instructed to adopt a "partial squat" position with slight flexion at the hips, knees, and ankle joints to damp the vibrations approximately at the pelvic level.
Treatment:
Procedure: WBV training
WBV+ PRT training
Experimental group
Treatment:
Procedure: WBV training
Procedure: PRT training
PRT training
Active Comparator group
Treatment:
Procedure: PRT training
Control group
Placebo Comparator group

Trial contacts and locations

1

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Central trial contact

Li Zhang, Doctor

Data sourced from clinicaltrials.gov

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