RCT of Vibration Effect on Vertebral BMD in Disabled Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoporosis
- Vibration Therapy
- Wheelchair
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Single (Participant)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
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 difficulti...
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.
Tracking Information
- NCT #
- NCT04180267
- Collaborators
- V-Health Limited
- Investigators
- Principal Investigator: Wing-hoi CHEUNG, Prof CUHK