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

Official title

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

Overview

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

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.

Interventions

• Other Whole Body Vibration Training
  Information already included in arm/group descriptions.
• Other Otago Exercise
  Usual Care

Primary outcome measures

• Isometric Knee Extension Strength [Time frame: Baseline and 2 weeks after intervention and 3 months after intervention]

Secondary outcome measures (10)

• Hand Grip Strength [Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention]
• Appendicular Skeletal Mass Index [Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention]
• Gait Speed [Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention]
• 5-timed chair stands [Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention]
• Calf Circumference [Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention]
• Physical Activity Scale for the Elderly (PASE) [Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention]
• Quality of life scale [Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention]
• Number of falls [Time frame: 1 year post interventions]
• 1 year unplanned emergency department visits and hospitalisation events [Time frame: 1 year post interventions]
• All-cause mortality [Time frame: up to 1 year post interventions]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Singapore · 1 center

• Changi General Hospital — Singapore

Publications

• Dyer SM, Crotty M, Fairhall N, Magaziner J, Beaupre LA, Cameron ID, Sherrington C; Fragility Fracture Network (FFN) Rehabilitation Research Special Interest Group. A critical review of the long-term disability outcomes following hip fracture. BMC Geriatr. 2016 Sep 2;16(1):158. doi: 10.1186/s12877-016-0332-0. PMID 27590604
• Akehurst H, Grice JE, Angioi M, Morrissey D, Migliorini F, Maffulli N. Whole-body vibration decreases delayed onset muscle soreness following eccentric exercise in elite hockey players: a randomised controlled trial. J Orthop Surg Res. 2021 Oct 12;16(1):589. doi: 10.1186/s13018-021-02760-4. PMID 34641941
• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. PMID 7154893
• Lee SY, Goh A, Tan K, Choo PL, Ong PH, Wong WP, Wee SL. Effectiveness of a community-delivered pneumatic machine resistance training programme (Gym Tonic) for older adults at neighbourhood senior centres - a randomized controlled trial. Eur Rev Aging Phys Act. 2021 Oct 7;18(1):21. doi: 10.1186/s11556-021-00273-x. PMID 34620081
• Claflin DR, Larkin LM, Cederna PS, Horowitz JF, Alexander NB, Cole NM, Galecki AT, Chen S, Nyquist LV, Carlson BM, Faulkner JA, Ashton-Miller JA. Effects of high- and low-velocity resistance training on the contractile properties of skeletal muscle fibers from young and older humans. J Appl Physiol (1985). 2011 Oct;111(4):1021-30. doi: 10.1152/japplphysiol.01119.2010. Epub 2011 Jul 28. PMID 21799130
• Burd NA, West DW, Staples AW, Atherton PJ, Baker JM, Moore DR, Holwerda AM, Parise G, Rennie MJ, Baker SK, Phillips SM. Low-load high volume resistance exercise stimulates muscle protein synthesis more than high-load low volume resistance exercise in young men. PLoS One. 2010 Aug 9;5(8):e12033. doi: 10.1371/journal.pone.0012033. PMID 20711498
• Yoshiko A, Watanabe K. Author Correction: Impact of home-based squat training with two-depths on lower limb muscle parameters and physical functional tests in older adults. Sci Rep. 2021 Jul 29;11(1):15802. doi: 10.1038/s41598-021-95096-2. No abstract available. PMID 34326445
• Chew STH, Kayambu G, Lew CCH, Ng TP, Ong F, Tan J, Tan NC, Tham SL. Singapore multidisciplinary consensus recommendations on muscle health in older adults: assessment and multimodal targeted intervention across the continuum of care. BMC Geriatr. 2021 May 17;21(1):314. doi: 10.1186/s12877-021-02240-8. PMID 34001023

Identifiers

NCT: NCT07205133 · ECOS Ref: 2025-0362 · AM/AG001/2025 (SRDUKAMR25G1)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗