Clinical trial NCT02090192: Effects of Whole-body Vibration in the Frail Elderly
Official title: Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia;
Osteoporosis
Keywords: Whole-body vibration;
Frail Elderly;
Blood flow;
Bone density
Mobility;
Balance;
Muscle strength;
Lower Extremity;
Musculoskeletal System;
Health Status;
Exercise;
Mechanical Oscillation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 160
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Change of the common femoral artery's blood flow from Baseline to 60min post-WBV
timeFrame: 60min post-WBV
measure: Change of lower extremities muscle strength from Baseline to 3 month post-WBV
timeFrame: 3 month post-WBV
measure: Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV
timeFrame: 3 month post-WBV
measure: Change of 30-second chair stand test from Baseline to 3 month post-WBV
timeFrame: 3 month post-WBV
measure: Change of balance function from Baseline to 3 month post-WBV
timeFrame: 3 month post-WBV
measure: Change of balance confidence from Baseline to 3 month post-WBV
timeFrame: 3 month post-WBV
measure: Change of bone density from Baseline to 6 month post-WBV
timeFrame: 6 month post-WBV
measure: Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
timeFrame: 6 month post-WBV
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Rehabilitation Department, Nanlou, Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Changshui Weng, Bachelor
role: STUDY_DIRECTOR
References: