Effects of Whole-body Vibration in the Frail Elderly

NCT02090192 | Unknown DMC

• 1 other identifier: ChinaPLAGH-2013FC3009
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

WBV training

EXPERIMENTAL

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.

Procedure: WBV training

WBV+ PRT training

EXPERIMENTAL

Procedure: WBV training; Procedure: PRT training

PRT training

ACTIVE COMPARATOR

Procedure: PRT training

Control group

PLACEBO COMPARATOR

Interventions

WBV training PROCEDURE

WBV training; WBV+ PRT training

PRT training PROCEDURE

PRT training; WBV+ PRT training

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥75 years old
• Fried Frailty Criteria
• Mini Mental State Examination score ≥18

You may not qualify if:

• 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

Sponsors & Collaborators

• Li Zhang: lead

Study Sites (1)

Rehabilitation Department, Nanlou, Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Osteoporosis; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Changshui Weng, Bachelor

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Li Zhang, Doctor

CONTACT

8610-66876335; zhangli781230@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

CN (1)