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NCT Number: NCT07205133

A Randomized Controlled Trial Comparing Whole Body Vibration Therapy With Usual Care and Usual Care to Improve Muscle Health in Older Adults

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body vibration training

Other

Information already included in arm/group descriptions.

Otago Exercise

Other

Usual Care

Primary outcomes

  1. Isometric Knee Extension Strength

    Time frame: Baseline and 2 weeks after intervention and 3 months after intervention

    Measured using a JTech Medical, Northstar Echo Muscle Tester with subject seated with knee flexed at 90 degrees and hanging, muscle tester is placed at the ventral surface of the ankle between malleoli and subject instructed to push against tester with maximal effort to extend the knee. Best of three trials would be taken.

Secondary outcomes

  1. Hand Grip Strength

    Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention

    Measured using Jtech Medical, Northstar Echo Grip hand dynamometer with participant sitting upright with elbows flexed at 90 degrees and arms unsupported, best of 3 tries from each hand.

  2. Appendicular Skeletal Mass Index

    Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention

    Height adjusted Appendicular Skeletal Mass index as measured by the InBody S10 Body Composition Analysis machine

  3. Gait Speed

    Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention

    6 metres normal gait speed (metres/second)

  4. 5-timed chair stands

    Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention

    Time taken to perform 5 chair stands with both arms crossed over chest (seconds)

  5. Calf Circumference

    Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention

    Widest calf circumference with participant in standing position

  6. Physical Activity Scale for the Elderly (PASE)

    Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention

    Assessment for physical activity level according to the PASE questionnaire

  7. Quality of life scale

    Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention

    QOL measured with the EQ-5D-5L

  8. Number of falls

    Time frame: 1 year post interventions

    Number of falls per participant during study period

  9. 1 year unplanned emergency department visits and hospitalisation events

    Time frame: 1 year post interventions

    as described above

  10. All-cause mortality

    Time frame: up to 1 year post interventions

    Mortality all-cause

Other outcomes

  1. Participant Surveys

    Time frame: 2 weeks post intervention up to 3 months post intervention

    Survey on user experience and satisfaction as well as feasibility, accessibility

  2. Exercise adherence

    Time frame: During 4 weeks intervention period

    Participants would be instructed to record their exercise participation in an exercise diary with remarks on any symptoms experienced.

  3. Semi-structured interviews

    Time frame: 2 weeks post intervention up to 3 months post intervention

    Semi-structured interviews would be conducted for the 20 participants in the WBVT (intervention) arm to enhance the qualitative data collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Yuanxin Chen, MBBS

CONTACT

[email protected]

+65-9030 4976

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • BMEC Pte Ltd

Registry information

Official study title

Effectiveness of Whole Body Vibration Therapy and Usual Care Compared to Usual Care in Improving Muscle Mass, Strength and Function in Older Adults

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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