Randomized comparison of whole-body vibration plus usual care versus usual care to improve muscle health in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, two-arm trial in which community-dwelling adults aged 65+ with clinical frailty scale scores of 3–4 are allocated to either whole-body vibration therapy plus usual care or to usual care alone. The intervention consists of a progressive 4-week WBVT program delivered three times per week, with measurements taken at baseline and at two post-intervention time points. The primary outcome is change in maximal isometric knee-extension strength from baseline to two weeks after the intervention, and secondary outcomes include appendicular skeletal muscle index, handgrip strength, gait speed, timed chair stands, quality of life, and physical activity level. The trial enrolls about 20 participants per arm and excludes people with dementia, recent hospital admission, poorly controlled chronic disease, or contraindications to vibration therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Changi General Hospital
  Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Christine Yuanxin Chen, MBBS
• Email: christine.chen.y.x@singhealth.com.sg
• Phone: +65-9030 4976

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.