Changi General Hospital
Singapore
Location status: Recruiting
NCT Number: NCT07205133
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Singapore
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contraindications to WBVT:
PRIMARY CONTRAINDICATIONS TO WBVT
SECONDARY CONTRAINDICATIONS TO WBVT
Information already included in arm/group descriptions.
Usual Care
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.
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.
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
Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention
6 metres normal gait speed (metres/second)
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)
Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention
Widest calf circumference with participant in standing position
Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention
Assessment for physical activity level according to the PASE questionnaire
Time frame: Baseline and at 2 weeks post intervention and 3 months post intervention
QOL measured with the EQ-5D-5L
Time frame: 1 year post interventions
Number of falls per participant during study period
Time frame: 1 year post interventions
as described above
Time frame: up to 1 year post interventions
Mortality all-cause
Time frame: 2 weeks post intervention up to 3 months post intervention
Survey on user experience and satisfaction as well as feasibility, accessibility
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.
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.
Contact information is provided by the study sponsor or research team.
Changi General Hospital
Other
Effectiveness of Whole Body Vibration Therapy and Usual Care Compared to Usual Care in Improving Muscle Mass, Strength and Function in Older Adults
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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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