Effects of Whole-body Vibration in the Frail Elderly

Overview

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.

Full Title of Study: “Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2015

Interventions

  • Procedure: WBV training
  • Procedure: PRT training

Arms, Groups and Cohorts

  • Experimental: WBV training
    • 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.
  • Experimental: WBV+ PRT training
  • Active Comparator: PRT training
  • Placebo Comparator: Control group

Clinical Trial Outcome Measures

Primary Measures

  • Change of the common femoral artery’s blood flow from Baseline to 60min post-WBV
    • Time Frame: 60min post-WBV
  • Change of lower extremities muscle strength from Baseline to 3 month post-WBV
    • Time Frame: 3 month post-WBV
  • Change of “timed up and go” test (TUGT) from Baseline to 3 month post-WBV
    • Time Frame: 3 month post-WBV
  • Change of 30-second chair stand test from Baseline to 3 month post-WBV
    • Time Frame: 3 month post-WBV
  • Change of balance function from Baseline to 3 month post-WBV
    • Time Frame: 3 month post-WBV
  • Change of balance confidence from Baseline to 3 month post-WBV
    • Time Frame: 3 month post-WBV
  • Change of bone density from Baseline to 6 month post-WBV
    • Time Frame: 6 month post-WBV
  • Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
    • Time Frame: 6 month post-WBV

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Li Zhang
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Li Zhang, Doctor – Chinese PLA General Hospital
  • Overall Official(s)
    • Changshui Weng, Bachelor, Study Director, Chinese PLA General Hospital
  • Overall Contact(s)
    • Li Zhang, Doctor, 8610-66876335, zhangli781230@163.com

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