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| ID | Type | Description | Link |
|---|---|---|---|
| AM/AG001/2025 (SRDUKAMR25G1) | Other Grant/Funding Number | Singhealth Duke-NUS Academic Medicine Research Grant 2.0 FY 2025: Special Category (Ageing Research- AGER) |
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| Name | Class |
|---|---|
| BMEC Pte Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Body Vibration Training | Experimental | The WBVT would be conducted using the Galileo Vibration machine (Galileo® S 35), for 3 sessions per week for 4 weeks. The participants would be progressed in terms of (i)vibration frequency from 15 Hz to at least 25 Hz (maximum 30 Hz for those who can tolerate) (ii)for the angles of their squats (from an approximate starting point of 20 degrees ("mini squats" to 45 degrees "quarter squats"; maximum to 90 degrees-thighs parallel to ground or "half-squats" for those who can tolerate); as well as (iii) increasing number of each 1-minute set (from 6 to 8 sets), while standing on the WBVT machine barefoot with both feet flat on the platform set at an amplitude of 2-3mm (according to the participant's height and body physique) with variable rest breaks (up to 1 minute) between each set for a total of 15 minutes each training session. Any missed session would be recorded. To ensure compliance, the subjects would receive a standard phone-call/text reminder prior to the scheduled session. |
|
| Usual Care | Active Comparator | Participants from both arms would also be provided the exercise sheet on "Otago exercises" (30)and demonstrated in one session how to perform the exercises. In-person demonstration of the "Otago exercises" would be done upon recruitment by trained study team members, at the visit for baseline measurements and a return-demonstration would be done after. They would be instructed to perform the Otago exercises daily according to the standardized instructions stated and progressed from 10 to 15 repetitions on their own for at least 3 times a week and advised to also continue other aerobic exercises, for example, brisk walking. Participants would be given an exercise and falls diary to record their exercise participation as well as any falls that occurred during the study duration for up to 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Body Vibration Training | Other | Information already included in arm/group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Isometric Knee Extension Strength | 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. | Baseline and 2 weeks after intervention and 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Grip Strength | 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. | Baseline and at 2 weeks post intervention and 3 months post intervention |
| Appendicular Skeletal Mass Index |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Surveys | Survey on user experience and satisfaction as well as feasibility, accessibility | 2 weeks post intervention up to 3 months post intervention |
| Exercise adherence | Participants would be instructed to record their exercise participation in an exercise diary with remarks on any symptoms experienced. |
Inclusion Criteria:
Exclusion Criteria:
Contraindications to WBVT:
PRIMARY CONTRAINDICATIONS TO WBVT
SECONDARY CONTRAINDICATIONS TO WBVT
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Yuanxin Chen, MBBS | Contact | +65-9030 4976 | christine.chen.y.x@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Recruiting | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27590604 | Background | 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. | |
| 34641941 | Background |
| Label | URL |
|---|---|
| Ministry of Health Singapore. MOH Frailty Strategy Policy Report \[Internet\]. \[cited 2024 Sep 5\] | View source |
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Individual participant data will not be shared at this time because participants were not explicitly consented for data sharing.
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Randomized Controlled Trial
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| Otago Exercise | Other | Usual Care |
|
Height adjusted Appendicular Skeletal Mass index as measured by the InBody S10 Body Composition Analysis machine |
| Baseline and at 2 weeks post intervention and 3 months post intervention |
| Gait Speed | 6 metres normal gait speed (metres/second) | Baseline and at 2 weeks post intervention and 3 months post intervention |
| 5-timed chair stands | Time taken to perform 5 chair stands with both arms crossed over chest (seconds) | Baseline and at 2 weeks post intervention and 3 months post intervention |
| Calf Circumference | Widest calf circumference with participant in standing position | Baseline and at 2 weeks post intervention and 3 months post intervention |
| Physical Activity Scale for the Elderly (PASE) | Assessment for physical activity level according to the PASE questionnaire | Baseline and at 2 weeks post intervention and 3 months post intervention |
| Quality of life scale | QOL measured with the EQ-5D-5L | Baseline and at 2 weeks post intervention and 3 months post intervention |
| Number of falls | Number of falls per participant during study period | 1 year post interventions |
| 1 year unplanned emergency department visits and hospitalisation events | as described above | 1 year post interventions |
| All-cause mortality | Mortality all-cause | up to 1 year post interventions |
| During 4 weeks intervention period |
| Semi-structured interviews | Semi-structured interviews would be conducted for the 20 participants in the WBVT (intervention) arm to enhance the qualitative data collected. | 2 weeks post intervention up to 3 months post intervention |
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| Ministry of Health Singapore. National Population Healthy Survey 2022 \[Internet\]. \[cited 2024 Sep 5\] | View source |
| Ministry of Health Singapore. The White Paper on Healthier SG \[Internet\]. \[cited 2024 Sep 5\] | View source |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
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