A Randomized Controlled Trial Comparing Whole Body Vibration Therapy With Usual Care and Usual Care to Improve Muscle Health in Older Adults
- Conditions
- AgingFrailtySarcopeniaMuscle StrengthMuscle FunctionMuscle Mass
- Registration Number
- NCT07205133
- Lead Sponsor
- Changi General Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Isometric Knee Extension Strength 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 Outcome Measures
Name Time Method Hand Grip Strength 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.
Appendicular Skeletal Mass Index 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
Gait Speed Baseline and at 2 weeks post intervention and 3 months post intervention 6 metres normal gait speed (metres/second)
5-timed chair stands 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)
Calf Circumference Baseline and at 2 weeks post intervention and 3 months post intervention Widest calf circumference with participant in standing position
Physical Activity Scale for the Elderly (PASE) Baseline and at 2 weeks post intervention and 3 months post intervention Assessment for physical activity level according to the PASE questionnaire
Quality of life scale Baseline and at 2 weeks post intervention and 3 months post intervention QOL measured with the EQ-5D-5L
Number of falls 1 year post interventions Number of falls per participant during study period
1 year unplanned emergency department visits and hospitalisation events 1 year post interventions as described above
All-cause mortality up to 1 year post interventions Mortality all-cause