A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention on Physical Function and Frailty Reversal, for Elderly Singaporeans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Change in Isometric Muscle Strength (Hip Abduction)
研究概览
简要总结
Launched in April 2015 , Gym Tonic is the first of its kind cross-border exercise-as-medicine partnership between research institutions, business enterprises and service providers from Singapore and Finland. What sets Gym Tonic apart from other exercise programmes is its singular focus on strength training, necessary for frailty prevention and maintenance of functional independence for the elderly.
This randomized-control trial is to validate the Gym Tonic programme and data as well measuring its effectiveness in improving physical functions and reversing frailty.
详细描述
The RCT is conducted in 3 eldercare community centers. In each center, a group of elderly will be randomly sorted into 2 groups. An intervention group and a control group.
The intervention group will go through 12 weeks of Gym Tonic progressive training programme. While the control group acts as a control. After the first 12 weeks, the intervention group will be going through another 12 weeks of Gym Tonic maintenance programme, while the control group will be going through the Gym Tonic progressive training programme.
Measurements of physical functions, isometric strength and frailty will be conducted pre trial, post 12 weeks and post 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Data is anonymized
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
- •Aged 65 years and above
- •Pre-frail or mildly frail, as measured by the 5 CHS criteria of physical frailty: unintentional weight loss, slowness, weakness, exhaustion, low activity level or FRAIL
- •Able to ambulate without personal assistance
- •Enrolled into the 3 sites above
排除标准
- •Terminally ill patients with life expectancy <12 months
- •Significant cognitive impairment
- •Major depression
- •Wear pacemaker
- •Severe audiovisual impairment
- •Any progressive, degenerative neurologic disease
- •Participating in other interventional studies
- •Unavailable to participate for the full duration of the study
结局指标
主要结局
Change in Isometric Muscle Strength (Hip Abduction)
时间窗: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
Change in Isometric Muscle Strength (Hip Adduction)
时间窗: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
Handgrip Strength
时间窗: week 0, week 12, week 24
Subject will be seated, with the arm unsupported, elbow joint at 90 degrees and wrist in a neutral position while holding the hand dynamometer. Subject would be required to squeeze the grip with maximum strength upon command for three attempts. The best result would be recorded.
SPPB Balance Test - Feet together (side-by-side)
时间窗: week 0, week 12, week 24
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
SPPB Speed Walk Test (Fast)
时间窗: week 0, week 12, week 24
To walk 4 metres at participant's fastest speed, scored point will be determined based on time taken to complete the 4-Metre walk.
Change in Isometric Muscle Strength (Knee Extension)
时间窗: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Change in Isometric Muscle Strength (Knee Flexion)
时间窗: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
SPPB Balance Test - Semi-Tandem stand
时间窗: week 0, week 12, week 24
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
SPPB Balance Test - Tandem stand
时间窗: week 0, week 12, week 24
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
SPPB 5 times sit-to-stand
时间窗: week 0, week 12, week 24
Seated with arms folded across chest and with their back against the chair, Stand up fully and sit down fully with the back against the chair as quickly as possible. Scored point will be determined by the time to completely finish 5 repetitions.
SPPB Speed Walk Test (Normal)
时间窗: week 0, week 12, week 24
To walk 4 metres at participant's usual speed, scored point will be determined based on time taken to complete the 4-Metre walk.
次要结局
未报告次要终点