Clinical trial NCT04180267: 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
Overall status: TERMINATED
Phase: NA
Conditions: Vibration Therapy
Wheelchair
Osteoporosis
Keywords: Osteoporosis
Vibration Therapy
Disabled patient
Vertebral BMD
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: V-Health Limited
First posted: 2019-11-27
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Vertebral BMD
timeFrame: Half year
Secondary outcomes:
measure: Muscle strength assessment
timeFrame: Half year
measure: Modified functional reach test
timeFrame: Half year
measure: Biodex Balance System
timeFrame: Half year
measure: 36-item Short-Form Health Survey (SF-36)
timeFrame: Half year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: ELCHK, Shan King Care And Attention Home For The Elderly
city: Hong Kong
country: Hong Kong
facility: Evangelical Lutheran Church Social Service - Hong Kong
city: Hong Kong
country: Hong Kong
facility: Sun Chui Lutheran Centre For The Elderly
Study officials:
affiliation: CUHK
name: Wing-hoi CHEUNG, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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