A Randomized Controlled Trial Comparing Whole Body Vibration Therapy With Usual Care and Usual Care to Improve Muscle Health in Older Adults
NCT ID: NCT07205133
Last Updated: 2025-10-03
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-10-31
2027-02-28
Brief Summary
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Detailed Description
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Aim: Our study aims to evaluate the effectiveness of a novel progressive 4-week, thrice-weekly WBVT intervention and usual care compared to usual care in improving muscle mass, strength and function in the pre-frail and mildly frail older adult.
Methods: 20 participants would be randomly allocated to each arm. The primary outcome is the between-group difference in change in maximal isometric knee-extension strength from baseline to 2 weeks post-intervention. Secondary outcomes include Appendicular Skeletal Mass Index (ASMI), hand grip strength (HGS), gait speed (GS), 5 timed chair stands, Quality of life (EQ-5D-5L) and physical activity level using the Physical Activity Scale for the Elderly (PASE). Other secondary outcomes include falls rate during the study, 1-year unplanned emergency department visits, hospitalizations as well as all-cause mortality. The measurements would be done at 3 points, namely pre-intervention (baseline), 2 weeks post-intervention and at 3 months. Qualitative data would include participant surveys and semi-structured interviews to assess feasibility, accessibility and future implementation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Whole Body Vibration Training
The WBVT would be conducted using the Galileo Vibration machine (Galileo® S 35), for 3 sessions per week for 4 weeks.
The participants would be progressed in terms of (i)vibration frequency from 15 Hz to at least 25 Hz (maximum 30 Hz for those who can tolerate) (ii)for the angles of their squats (from an approximate starting point of 20 degrees ("mini squats" to 45 degrees "quarter squats"; maximum to 90 degrees-thighs parallel to ground or "half-squats" for those who can tolerate); as well as (iii) increasing number of each 1-minute set (from 6 to 8 sets), while standing on the WBVT machine barefoot with both feet flat on the platform set at an amplitude of 2-3mm (according to the participant's height and body physique) with variable rest breaks (up to 1 minute) between each set for a total of 15 minutes each training session.
Any missed session would be recorded. To ensure compliance, the subjects would receive a standard phone-call/text reminder prior to the scheduled session.
Whole Body Vibration Training
Information already included in arm/group descriptions.
Otago Exercise
Usual Care
Usual Care
Participants from both arms would also be provided the exercise sheet on "Otago exercises" (30)and demonstrated in one session how to perform the exercises. In-person demonstration of the "Otago exercises" would be done upon recruitment by trained study team members, at the visit for baseline measurements and a return-demonstration would be done after. They would be instructed to perform the Otago exercises daily according to the standardized instructions stated and progressed from 10 to 15 repetitions on their own for at least 3 times a week and advised to also continue other aerobic exercises, for example, brisk walking. Participants would be given an exercise and falls diary to record their exercise participation as well as any falls that occurred during the study duration for up to 3 months.
Otago Exercise
Usual Care
Interventions
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Whole Body Vibration Training
Information already included in arm/group descriptions.
Otago Exercise
Usual Care
Eligibility Criteria
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Inclusion Criteria
* Clinical frailty Scale (CFS) score of 3-4,
* Independently ambulating without any aid
* willingness and consent to participate in the study and ability to travel to the study-site for the measurements and interventions, and
* participants with no regular exercise habits (defined as less than 150mins/week of moderate intensity aerobic exercise and less than twice a week of strengthening exercises)for past 3 months.
Exclusion Criteria
* contraindications to WBVT machine usage (see below),
* diagnosis of dementia,
* history of Diabetes Mellitus
* BMI ≤20kg/m2,
* recent hospital admissions within the last 3 months,
* end stage organ failure,
* chronic diseases which are not well managed, for example, poorly controlled hypertension,
* New York Heart Association (NYHA) score II and above for patients with history of heart failure and
* MUST Score ≥1.
Contraindications to WBVT:
PRIMARY CONTRAINDICATIONS TO WBVT
* Pregnancy
* Acute thrombosis (acute vascular occlusion)
* Artificial joints in stimulated body regions
* Fresh fractures in stimulated body regions
* Within 3 months post surgery/procedure and/or any fresh wounds and scars in the stimulated body regions
* or if the wound healing is not yet completely finished.
SECONDARY CONTRAINDICATIONS TO WBVT
* Acute inflammation of the musculoskeletal system, activated arthrosis or
* arthropathy (e.g. acute inflammation and swelling in joints).
* Acute tendinopathies in stimulated body regions (acute tendonitis)
* Acute hernias (tissue ruptures)
* Acute discopathy (acute disc-related back problem)
* Stone disease of the bile ducts and urinary tract
* Rheumatoid Arthritis
* Epilepsy due to secondary risk of injury
65 Years
ALL
Yes
Sponsors
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BMEC Pte Ltd
UNKNOWN
Changi General Hospital
OTHER
Responsible Party
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Christine Chen Yuanxin
Doctor
Central Contacts
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References
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Related Links
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Ministry of Health Singapore. MOH Frailty Strategy Policy Report \[Internet\]. \[cited 2024 Sep 5\]
Ministry of Health Singapore. National Population Healthy Survey 2022 \[Internet\]. \[cited 2024 Sep 5\]
Ministry of Health Singapore. The White Paper on Healthier SG \[Internet\]. \[cited 2024 Sep 5\]
Other Identifiers
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AM/AG001/2025 (SRDUKAMR25G1)
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ECOS Ref: 2025-0362
Identifier Type: -
Identifier Source: org_study_id
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