RCT of Vibration Effect on Vertebral BMD in Disabled Patients
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|ClinicalTrials.gov Identifier: NCT04180267|
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vibration Therapy Wheelchair Osteoporosis||Device: Low-magnitude High-frequency Vibration||Not Applicable|
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:  cannot stand and walk independently,  have vibration treatment before,  with malignancy,  with acute fractures or severe osteoarthritis (18),  with cardiovascular concern such as with pace-maker in-situ,  with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis, and  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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Official Title:||Efficacy of Low-magnitude High-frequency Vibration (LMHFV) on Musculoskeletal Health of Subjects on Wheelchair, a Randomized Controlled Study.|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
No Intervention: Control Group
Subject assigned to Control Group will not receive LMHFV
Active Comparator: LMHFV group
Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year.
Device: Low-magnitude High-frequency Vibration
35Hz, 0.3g, 20min/day, at least 3 times/week
Other Name: Vibration Treatment
- Vertebral BMD [ Time Frame: 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.
- Muscle strength assessment [ Time Frame: Half year ]Handgrip strength and quadriceps strength
- Modified functional reach test [ Time Frame: Half year ]Fall risk assessment for dynamic sitting balance
- Biodex Balance System [ Time Frame: Half year ]Postural stability test
- 36-item Short-Form Health Survey (SF-36) [ Time Frame: Half year ]Assessment of health-related quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180267
|Contact: Chung Yan Ho, Ms||35052756 ext email@example.com|
|ELCHK, Shan King Care And Attention Home For The Elderly||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Yuen Yee Iris Chan, Ms 24676612 ext 852 firstname.lastname@example.org|
|Evangelical Lutheran Church Social Service - Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Kam Lee Lam, Ms 31247633 email@example.com|
|Sun Chui Lutheran Centre For The Elderly||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Shun Shun Lam, Ms 26996283 firstname.lastname@example.org|
|Principal Investigator:||Wing-hoi CHEUNG, Prof||CUHK|