Effects of Whole-body Vibration in the Frail Elderly

Not Applicable

• Conditions: Sarcopenia; Osteoporosis

• Registration Number: NCT02090192
• Lead Sponsor: Li Zhang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-16
• Last Update Submitted: 2014-03-16
• Study First Posted: 2014-03-18
• Last Update Posted: 2014-03-18
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rehabilitation Department, Nanlou, Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China