Effects of Whole-body Vibration in the Frail Elderly

NCT ID: NCT02090192

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Sarcopenia; Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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WBV training

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.

Group Type EXPERIMENTAL

WBV training

Intervention Type PROCEDURE

WBV+ PRT training

Group Type EXPERIMENTAL

WBV training

Intervention Type PROCEDURE

PRT training

Intervention Type PROCEDURE

PRT training

Group Type ACTIVE_COMPARATOR

PRT training

Intervention Type PROCEDURE

Control group

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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WBV training

Intervention Type PROCEDURE

PRT training

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Li Zhang

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Changshui Weng, Bachelor

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

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Rehabilitation Department, Nanlou, Chinese PLA general hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Zhang, Doctor

Role: CONTACT

8610-66876335

Facility Contacts

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Chunhua Li, Bachelor

Role: primary

8610-66875462

Other Identifiers

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ChinaPLAGH-2013FC3009

Identifier Type: -

Identifier Source: org_study_id

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