Effectiveness of Whole Body Vibration Therapy and Usual Care Compared to Usual Care in Improving Muscle Mass, Strength and Function in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Isometric Knee Extension Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 ≥
- •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
研究组 & 干预措施
Whole Body Vibration Training
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.
干预措施: Whole Body Vibration Training (Other)
Whole Body Vibration Training
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.
干预措施: Otago Exercise (Other)
Usual Care
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.
干预措施: Otago Exercise (Other)
结局指标
主要结局
Isometric Knee Extension Strength
时间窗: 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.
Isometric Knee Extension Strength
时间窗: 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.
次要结局
- Hand Grip Strength(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Appendicular Skeletal Mass Index(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Gait Speed(Baseline and at 2 weeks post intervention and 3 months post intervention)
- 5-timed chair stands(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Calf Circumference(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Physical Activity Scale for the Elderly (PASE)(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Quality of life scale(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Number of falls(1 year post interventions)
- 1 year unplanned emergency department visits and hospitalisation events(1 year post interventions)
- All-cause mortality(up to 1 year post interventions)
- Hand Grip Strength(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Appendicular Skeletal Mass Index(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Gait Speed(Baseline and at 2 weeks post intervention and 3 months post intervention)
- 5-timed chair stands(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Calf Circumference(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Physical Activity Scale for the Elderly (PASE)(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Quality of life scale(Baseline and at 2 weeks post intervention and 3 months post intervention)
- Number of falls(1 year post interventions)
- 1 year unplanned emergency department visits and hospitalisation events(1 year post interventions)
- All-cause mortality(up to 1 year post interventions)
研究者
Christine Chen Yuanxin
Doctor
Changi General Hospital