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RCT of Vibration Effect on Vertebral BMD in Disabled Patients

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ClinicalTrials.gov Identifier: NCT04180267
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
V-Health Limited
Information provided by (Responsible Party):
Professor CHEUNG Wing hoi, Louis, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vibration Therapy Wheelchair Osteoporosis Device: Low-magnitude High-frequency Vibration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subject will be randomized to either LMHFV group or control group. Subject assigned to LMHFV group will receive Low-magnitude High-frequency Vibration (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year. The primary outcome is the effect of LMHFV on BMD at the lumbar spine, it will be assessed by dual-energy X-ray absorptiometry (DXA) that is clinically recommended for the diagnosis of osteoporosis. Secondary outcomes include muscle strength assessment, balancing ability and quality of life (QoL). All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline and 6 months post treatment.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy of Low-magnitude High-frequency Vibration (LMHFV) on Musculoskeletal Health of Subjects on Wheelchair, a Randomized Controlled Study.
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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 Name: Vibration Treatment




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Muscle strength assessment [ Time Frame: Half year ]
    Handgrip strength and quadriceps strength

  2. Modified functional reach test [ Time Frame: Half year ]
    Fall risk assessment for dynamic sitting balance

  3. Biodex Balance System [ Time Frame: Half year ]
    Postural stability test

  4. 36-item Short-Form Health Survey (SF-36) [ Time Frame: Half year ]
    Assessment of health-related quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180267


Contacts
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Contact: Chung Yan Ho, Ms 35052756 ext 852 hcyan0822@cuhk.edu.hk

Locations
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Hong Kong
ELCHK, Shan King Care And Attention Home For The Elderly Recruiting
Hong Kong, Hong Kong
Contact: Yuen Yee Iris Chan, Ms    24676612 ext 852    irischan@elchk.org.hk   
Evangelical Lutheran Church Social Service - Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Kam Lee Lam, Ms    31247633    kamleelam@elck.org.hk   
Sun Chui Lutheran Centre For The Elderly Recruiting
Hong Kong, Hong Kong
Contact: Shun Shun Lam, Ms    26996283    shunshun.lam@hklss.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
V-Health Limited
Investigators
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Principal Investigator: Wing-hoi CHEUNG, Prof CUHK
Publications of Results:

Other Publications:

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Responsible Party: Professor CHEUNG Wing hoi, Louis, Associate Professor of Orthopaedics and Traumatology, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04180267    
Other Study ID Numbers: CREC 2019.087
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor CHEUNG Wing hoi, Louis, Chinese University of Hong Kong:
Osteoporosis
Vibration Therapy
Disabled patient
Vertebral BMD
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases