RCT of Vibration Effect on Vertebral BMD in Disabled Patients
Primary Purpose
Vibration Therapy, Wheelchair, Osteoporosis
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Low-magnitude High-frequency Vibration
Sponsored by
About this trial
This is an interventional prevention trial for Vibration Therapy focused on measuring Osteoporosis, Vibration Therapy, Disabled patient, Vertebral BMD
Eligibility Criteria
Inclusion Criteria:
- Subjects of both genders aged ≥ 65 years
- Wheelchair users with walking difficulties
- Subjects with good general health conditions
Exclusion Criteria:
- Subjects cannot stand and walk independently
- Subjects who had vibration treatment before
- Subjects with malignancy
- Subjects with acute fractures or severe osteoarthritis
- Subjects with cardiovascular concern such as with pace-maker in-situ
- Subjects with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis
- Subjects with high frequency of physical activities, such as subjects who participated in regular exercise five times a week or more
Sites / Locations
- ELCHK, Shan King Care And Attention Home For The ElderlyRecruiting
- Evangelical Lutheran Church Social Service - Hong KongRecruiting
- Sun Chui Lutheran Centre For The ElderlyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
LMHFV group
Arm Description
Subject assigned to Control Group will not receive LMHFV
Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year.
Outcomes
Primary Outcome Measures
Vertebral BMD
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
Muscle strength assessment
Handgrip strength and quadriceps strength
Modified functional reach test
Fall risk assessment for dynamic sitting balance
Biodex Balance System
Postural stability test
36-item Short-Form Health Survey (SF-36)
Assessment of health-related quality of life
Full Information
NCT ID
NCT04180267
First Posted
November 26, 2019
Last Updated
March 8, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
V-Health Limited
1. Study Identification
Unique Protocol Identification Number
NCT04180267
Brief Title
RCT of Vibration Effect on Vertebral BMD in Disabled Patients
Official Title
Efficacy of Low-magnitude High-frequency Vibration (LMHFV) on Musculoskeletal Health of Subjects on Wheelchair, a Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
V-Health Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vibration Therapy, Wheelchair, Osteoporosis
Keywords
Osteoporosis, Vibration Therapy, Disabled patient, Vertebral BMD
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subject assigned to Control Group will not receive LMHFV
Arm Title
LMHFV group
Arm Type
Active Comparator
Arm Description
Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year.
Intervention Type
Device
Intervention Name(s)
Low-magnitude High-frequency Vibration
Other Intervention Name(s)
Vibration Treatment
Intervention Description
35Hz, 0.3g, 20min/day, at least 3 times/week
Primary Outcome Measure Information:
Title
Vertebral BMD
Description
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.
Time Frame
Half year
Secondary Outcome Measure Information:
Title
Muscle strength assessment
Description
Handgrip strength and quadriceps strength
Time Frame
Half year
Title
Modified functional reach test
Description
Fall risk assessment for dynamic sitting balance
Time Frame
Half year
Title
Biodex Balance System
Description
Postural stability test
Time Frame
Half year
Title
36-item Short-Form Health Survey (SF-36)
Description
Assessment of health-related quality of life
Time Frame
Half year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of both genders aged ≥ 65 years
Wheelchair users with walking difficulties
Subjects with good general health conditions
Exclusion Criteria:
Subjects cannot stand and walk independently
Subjects who had vibration treatment before
Subjects with malignancy
Subjects with acute fractures or severe osteoarthritis
Subjects with cardiovascular concern such as with pace-maker in-situ
Subjects with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis
Subjects with high frequency of physical activities, such as subjects who participated in regular exercise five times a week or more
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Yan Ho, Ms
Phone
35052756
Ext
852
Email
hcyan0822@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing-hoi CHEUNG, Prof
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
ELCHK, Shan King Care And Attention Home For The Elderly
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuen Yee Iris Chan, Ms
Phone
24676612
Ext
852
Email
irischan@elchk.org.hk
Facility Name
Evangelical Lutheran Church Social Service - Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kam Lee Lam, Ms
Phone
31247633
Email
kamleelam@elck.org.hk
Facility Name
Sun Chui Lutheran Centre For The Elderly
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shun Shun Lam, Ms
Phone
26996283
Email
shunshun.lam@hklss.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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RCT of Vibration Effect on Vertebral BMD in Disabled Patients
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