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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-02-28

Brief Summary

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This study is a randomized controlled trial where participants would be randomly assigned to one of 2 groups. One group would receive Whole body vibration therapy and usual care and the other group only usual care. Measurements of muscle mass, strength and function would be taken before the interventions, and at 2 other points after interventions. Differences in the outcomes between the two groups would be analysed.

Detailed Description

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Background: The prevalence of Frailty and Sarcopenia is increasing with increasing proportion of older adults in the population. While screening for frailty and sarcopenia has become more common, frailty interventions are still developing. Effective interventions include resistance exercise programs that are progressive and sustained. However, take up rate and adherence to these programs are low due to many barriers like time, cost and convenience to the older adult. Many older adults who are frail may be unable to adhere to exercise programs due to cognitive impairment and tolerability. An alternative modality, Whole Body Vibration Training (WBVT), has emerged with evidence in improving muscle strength and function which may be easier to complete and a safe alternative.

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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Aging Frailty Sarcopenia Muscle Strength Muscle Function Muscle Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Whole Body Vibration Training

Intervention Type OTHER

Information already included in arm/group descriptions.

Otago Exercise

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Otago Exercise

Intervention Type OTHER

Usual Care

Interventions

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Whole Body Vibration Training

Information already included in arm/group descriptions.

Intervention Type OTHER

Otago Exercise

Usual Care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteer or Patients aged 65 and above,
* 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

* current active enrolment into any Day Rehab or community exercise program,
* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BMEC Pte Ltd

UNKNOWN

Sponsor Role collaborator

Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christine Chen Yuanxin

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Christine Yuanxin Chen, MBBS

Role: CONTACT

+65-9030 4976

References

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Related Links

Access external resources that provide additional context or updates about the study.

https://www.moh.gov.sg/resources-statistics/reports/frailty-strategy-policy-report

Ministry of Health Singapore. MOH Frailty Strategy Policy Report \[Internet\]. \[cited 2024 Sep 5\]

https://www.moh.gov.sg/resources-statistics/reports/national-population-health-survey-2022

Ministry of Health Singapore. National Population Healthy Survey 2022 \[Internet\]. \[cited 2024 Sep 5\]

https://www.healthiersg.gov.sg/resources/white-paper/

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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