RCT of Vibration Effect on Vertebral BMD in Disabled Patients

March 8, 2022 updated by: Professor CHEUNG Wing hoi, Louis, Chinese University of Hong Kong

Efficacy of Low-magnitude High-frequency Vibration (LMHFV) on Musculoskeletal Health of Subjects on Wheelchair, a Randomized Controlled Study.

Osteoporosis is an age-related disease with progressive loss of bone, leading to fragile bone. It is one of the major health issues in elderly and causes medical, social and economic impacts globally. Patients with osteoporosis have high risk of osteoporotic fractures. Low-magnitude high-frequency vibration (LMHFV) is a non-invasive biophysical intervention providing whole-body mechanical stimulation. Previous studies showed that LMHFV is beneficial to muscle strength(1), postural control(2), balancing ability(3, 4), new bone formation(5-7), spinal bone mineral density (BMD)(8), and blood circulation(9). During the LMHFV treatment, elderly needs to stand upright on the platform for 20min/day. However, some elderlies with poor standing ability cannot stand for a long period. Therefore, the design of vibration platform is modified for the disabled patients and the efficacy of LMHFV on this group of elderlies will be verified. It is hypothesized that new design of LMHFV is beneficial to wheelchair users in terms of vertebral bone mineral density, muscle health and musculoskeletal functions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single-blinded randomized controlled trial to investigate the effect of LMHFV on vertebral BMD, muscle health, balancing ability and functional ability in wheelchair users (mainly on wheelchair for outdoor activities).

Healthy elderlies aged 65 years or above, with walking difficulties and using wheelchair are eligible. We exclude anyone who: [1] cannot stand and walk independently, [2] have vibration treatment before, [3] with malignancy, [4] with acute fractures or severe osteoarthritis (18), [5] with cardiovascular concern such as with pace-maker in-situ, [6] with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis, and [7] with high frequency of physical activities, such as subjects who participated in regular exercise five times a week or more.

Recruited subjects will be randomized to either LMHFV or control group. Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. The primary outcome is BMD at the lumbar spine to be assessed by dual-energy X-ray absorptiometry (DXA) that is clinically recommended for the diagnosis of osteoporosis. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline and 6 months post-treatment.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • ELCHK, Shan King Care And Attention Home For The Elderly
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Evangelical Lutheran Church Social Service - Hong Kong
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Sun Chui Lutheran Centre For The Elderly
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects of both genders aged ≥ 65 years
  2. Wheelchair users with walking difficulties
  3. Subjects with good general health conditions

Exclusion Criteria:

  1. Subjects cannot stand and walk independently
  2. Subjects who had vibration treatment before
  3. Subjects with malignancy
  4. Subjects with acute fractures or severe osteoarthritis
  5. Subjects with cardiovascular concern such as with pace-maker in-situ
  6. Subjects with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis
  7. Subjects with high frequency of physical activities, such as subjects who participated in regular exercise five times a week or more

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
Subject assigned to Control Group will not receive LMHFV
ACTIVE_COMPARATOR: LMHFV group
Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year.
Device: Low-magnitude High-frequency Vibration
35Hz, 0.3g, 20min/day, at least 3 times/week
Other Names:
  • Vibration Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vertebral BMD
Time Frame: Half year
BMD will be assessed by standard DXA equipment (Delphi W, Hologic, Waltham, MA, USA) which is a gold standard assessment for osteoporosis recommended by World Health Organization (WHO). Spine and hip are the two sites used for the diagnosis of osteoporosis and will be both performed.
Half year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength assessment
Time Frame: Half year
Handgrip strength and quadriceps strength
Half year
Modified functional reach test
Time Frame: Half year
Fall risk assessment for dynamic sitting balance
Half year
Biodex Balance System
Time Frame: Half year
Postural stability test
Half year
36-item Short-Form Health Survey (SF-36)
Time Frame: Half year
Assessment of health-related quality of life
Half year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

V-Health Limited

Investigators

  • Principal Investigator: Wing-hoi CHEUNG, Prof, CUHK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (ACTUAL)

November 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 2019.087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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