Effects of Whole-body Vibration in the Frail Elderly

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02090192
• Other study ID #: ChinaPLAGH-2013FC3009
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 16, 2014
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2014
• Source: Chinese PLA General Hospital
• Contact: Li Zhang, Doctor
• Phone: 8610-66876335
• Email: zhangli781230[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Sarcopenia
• Sarcopenia;

Intervention

Procedure:
• WBV training

• PRT training

Locations

Country	Name	City	State
China	Rehabilitation Department, Nanlou, Chinese PLA general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Li Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the common femoral artery's blood flow from Baseline to 60min post-WBV		60min post-WBV	No
Primary	Change of lower extremities muscle strength from Baseline to 3 month post-WBV		3 month post-WBV	No
Primary	Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV		3 month post-WBV	No
Primary	Change of 30-second chair stand test from Baseline to 3 month post-WBV		3 month post-WBV	No
Primary	Change of balance function from Baseline to 3 month post-WBV		3 month post-WBV	No
Primary	Change of balance confidence from Baseline to 3 month post-WBV		3 month post-WBV	No
Primary	Change of bone density from Baseline to 6 month post-WBV		6 month post-WBV	Yes
Primary	Change of general health status (SF-12 score) from Baseline to 6 month post-WBV		6 month post-WBV	No