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Effects of Whole-body Vibration in the Frail Elderly

Primary Purpose

Sarcopenia;, Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WBV training
PRT training
Sponsored by
Li Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia; focused on measuring Whole-body vibration;, Frail Elderly;, Blood flow;, Bone density, Mobility;, Balance;, Muscle strength;, Lower Extremity;, Musculoskeletal System;, Health Status;, Exercise;, Mechanical Oscillation

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rehabilitation Department, Nanlou, Chinese PLA general hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

WBV training

WBV+ PRT training

PRT training

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 14, 2014
Last Updated
March 16, 2014
Sponsor
Li Zhang
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1. Study Identification

Unique Protocol Identification Number
NCT02090192
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Zhang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WBV training
Arm Type
Experimental
Arm Description
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.
Arm Title
WBV+ PRT training
Arm Type
Experimental
Arm Title
PRT training
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
WBV training
Intervention Type
Procedure
Intervention Name(s)
PRT training
Primary Outcome Measure Information:
Title
Change of the common femoral artery's blood flow from Baseline to 60min post-WBV
Time Frame
60min post-WBV
Title
Change of lower extremities muscle strength from Baseline to 3 month post-WBV
Time Frame
3 month post-WBV
Title
Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV
Time Frame
3 month post-WBV
Title
Change of 30-second chair stand test from Baseline to 3 month post-WBV
Time Frame
3 month post-WBV
Title
Change of balance function from Baseline to 3 month post-WBV
Time Frame
3 month post-WBV
Title
Change of balance confidence from Baseline to 3 month post-WBV
Time Frame
3 month post-WBV
Title
Change of bone density from Baseline to 6 month post-WBV
Time Frame
6 month post-WBV
Title
Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
Time Frame
6 month post-WBV

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhang, Doctor
Phone
8610-66876335
Email
zhangli781230@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changshui Weng, Bachelor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rehabilitation Department, Nanlou, Chinese PLA general hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunhua Li, Bachelor
Phone
8610-66875462
Email
18601224462@163.com

12. IPD Sharing Statement

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Effects of Whole-body Vibration in the Frail Elderly

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