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RCT of Vibration Effect on Vertebral BMD in Disabled Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04180267
Enrollment
37
Registered
2019-11-27
Start date
2019-07-19
Completion date
2024-02-08
Last updated
2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Vibration Therapy, Wheelchair

Keywords

Osteoporosis, Vibration Therapy, Disabled patient, Vertebral BMD

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.

Interventions

35Hz, 0.3g, 20min/day, at least 3 times/week

Sponsors

V-Health Limited
CollaboratorUNKNOWN
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vertebral BMDHalf yearBMD 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

MeasureTime frameDescription
Muscle strength assessmentHalf yearHandgrip strength and quadriceps strength
Modified functional reach testHalf yearFall risk assessment for dynamic sitting balance
Biodex Balance SystemHalf yearPostural stability test
36-item Short-Form Health Survey (SF-36)Half yearAssessment of health-related quality of life

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026