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Clinical Trials/NCT02090192
NCT02090192
Unknown
N/A

Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly

Li Zhang1 site in 1 country160 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia;
Sponsor
Li Zhang
Enrollment
160
Locations
1
Primary Endpoint
Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Li Zhang
Responsible Party
Sponsor Investigator
Principal Investigator

Li Zhang

Doctor

Chinese PLA General Hospital

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Change of general health status (SF-12 score) from Baseline to 6 month post-WBV

Time Frame: 6 month post-WBV

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

Study Sites (1)

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