RCT of Vibration Effect on Vertebral BMD in Disabled Patients

Not Applicable

Terminated

• Conditions: Osteoporosis; Wheelchair; Vibration Therapy
• Interventions: Device: Low-magnitude High-frequency Vibration

• Registration Number: NCT04180267
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-07-19
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Primary Completion: 2024-02-08
• Study Completion: 2024-02-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMHFV group	Low-magnitude High-frequency Vibration	Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year.

Primary Outcome Measures

Name	Time	Method
Vertebral BMD	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

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

Trial Locations

Locations (3)

ELCHK, Shan King Care And Attention Home For The Elderly; 🇭🇰 Hong Kong, Hong Kong

Evangelical Lutheran Church Social Service - Hong Kong; 🇭🇰 Hong Kong, Hong Kong

Sun Chui Lutheran Centre For The Elderly; 🇭🇰 Hong Kong, Hong Kong