Semi-Recumbent Vibration Therapy in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
研究概览
简要总结
This proposed prospective study will evaluate whether a novel exercise approach, seated vibration therapy, can improve function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of vibration therapy on muscle function (balance, muscle power and strength) and muscle mass.
详细描述
There are four study visits; screening/baseline followed by eight weeks of training three times a week, visit 1 at eight weeks followed by 4 weeks of washout, Visit 2 at 12 weeks followed by eight weeks of training three times a week, and a final Visit 3 at 20 weeks.
At the screening visit, volunteers will be asked to perform tests included in the short physical performance battery (SPPB) (gait speed, chair rise, balance). If the participants score is ≤ 9 or ≤ 2 in any of the three tests included in the SPPB they will be eligible for the intervention phase. At the baseline visit several questionnaires will be obtained and participants then will proceed with muscle function tests (SPPB, jumping mechanography, grip strength, timed-up-and-go test).
Participants will then be randomized into one of two groups. The first group will receive vibration + loading treatment for the first 8 weeks, the second group will receive sham treatment (loading only). After 8 weeks both groups will go through a 4 week wash-out period and then crossover will occur. The first group will now receive sham treatment (loading only) while the second group will receive vibration + loading treatment. The participants will train for 10 minutes, 3 times a week, during the active 16 total weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women age ≥ 70 years
- •Able and willing to sign informed consent
- •Able to stand without assistance
- •Able and willing to train for 10 minutes, 3 times per week
- •Total SPPB score of ≤ 9 or ≤ 2 in any of the three tests included in the SPPB
排除标准
- •Cognitive impairment to the degree that it limits the ability of signing informed consent
- •Unable to sit upright for 10 minutes
- •History of injury or surgery within the prior six months which limits the ability to ambulate
- •Major illness that might cause missed training sessions or visits.
研究组 & 干预措施
Combination Treatment
In the "loading + vibration group" (intervention group), subjects will be seated in the VibeTech One system and vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g.
干预措施: VibeTech One (Device)
Sham Treatment
In the "loading only" group (control group) participants will be seated in the vibration device (VibeTech One) and will experience loading of their leg muscles through the device.
干预措施: VibeTech One (Device)
结局指标
主要结局
Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate
时间窗: This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.
The primary aim of this pilot is to examine the effect of vibration therapy on muscle function. Weight corrected jump power will be the main outcome variable. Countermovement jumps are performed on a Leonardo force plate (Novotec Medical, Pforzheim, Germany) following standard procedures. Jumping mechanography uses maximal countermovement jumps to quantitatively measure muscle strength in the legs. Participants will be asked to perform three countermovement jumps. Participants are asked to try to jump as high as possible using both legs. Three jumps are performed; the jump with the highest jump height is used for analysis.
次要结局
- Grip Strength(Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.)
- Gait Speed(Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.)
- Short Physical Performance Battery (SPPB)(Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.)
- Timed-Up-and-Go (TUG)(Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.)
- Sway(Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.)
- Bioelectrical Impedance Spectroscopy (BIS)(Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.)