RCT of Vibration Effect on Vertebral BMD in Disabled Patients

NCT ID: NCT04180267

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2024-02-08

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.

Conditions

Vibration Therapy; Wheelchair; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

Subject assigned to Control Group will not receive LMHFV

Group Type: NO_INTERVENTION

No interventions assigned to this group

LMHFV group

Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year.

Group Type: ACTIVE_COMPARATOR

Low-magnitude High-frequency Vibration

Intervention Type: DEVICE

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

Interventions

Low-magnitude High-frequency Vibration

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

Intervention Type: DEVICE

Other Intervention Names

Vibration 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

V-Health Limited

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor CHEUNG Wing hoi, Louis

Associate Professor of Orthopaedics and Traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wing-hoi CHEUNG, Prof

Role: PRINCIPAL_INVESTIGATOR

CUHK

Locations

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

Countries

Hong Kong

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Other Identifiers

CREC 2019.087

Identifier Type: -

Identifier Source: org_study_id