Effect of a 12-week Training Program With Unstable Devices on Strength and Dynamic Balance in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Lower limb isometric strength
研究概览
简要总结
Ageing involves several physiological changes such as loss of muscle mass, muscle strength, and alteration of balance control mechanisms. Consequently, there is an increased fall risk that can lead the older adult to a reduced self-sufficiency in daily living activities. Investigating the role of different physical activities to counteract the age-related declines deserves attention. The present study aimed to evaluate the effects of two trainings performed with and without unstable devices, on dynamic balance control and lower limb strength compared to a control group that received no intervention.
详细描述
The a-priori power analysis calculation reported a total sample size of 51 participants. We decided to increase the sample size of approximatively 20% hypothesizing an increment of drop-outs due to the not completely solved COVID-19 pandemic at the time of the study.
In this single-blinded randomized controlled study, both intervention groups received 24 training sessions of 45 minutes each, twice a week for 12 weeks.The two intervention groups and the control group were tested at the baseline (T0), after six weeks (T1), and after twelve weeks (T2).
Subjects of the intervention groups had to complete at least 21 out of 24 training sessions. Moreover, all subjects had to complete all the assessments. Otherwise, they were completely excluded from the data analysis.
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 (Participant)
盲法说明
Single-blind study: only the researchers doing the study know which treatment or intervention the participant is receiving until the study is over.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-sufficiency in daily living activities;
- •aged between 65 and 85 years.
排除标准
- •non-corrected sight disorders
- •neurological disorders
- •regular assumption of drugs that can interfere with normal cognitive functioning
- •pathologies that contraindicate physical activity practice
结局指标
主要结局
Lower limb isometric strength
时间窗: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Isometric quadriceps maximal strength (Newton) measured with an instrumented chair. Specifically, a load cell is placed perpendicular to the subject's shank and collects the force in Newton expressed by the subject while sitting on the chair. The knee angle during the maximal effort is fixed at 90 degrees.
Center of Pressure (CoP) Unit Path
时间窗: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: \- The mean velocity of the CoP measured in cm∙s-1 (Unit Path) over a 2.5-second time window from the beginning of the perturbation;
Center of Pressure (CoP) Area95
时间窗: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: \- The area of the 95th percentile confidence ellipse of the CoP measured in cm2 (Area95) over a 2.5-second time window from the beginning of the perturbation.
Center of Pressure (CoP) First Peak
时间窗: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: \- First peak (FP) as the difference in centimeters between the peak reached by the CoP displacement after the external perturbation and the mean value of the anterior-posterior CoP displacement before the perturbation.
Center of Pressure (CoP) Maximal Oscillation
时间窗: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: \- Maximal oscillation of the CoP anterior-posterior displacement as the sum in centimeters of the absolute values of FP and the subsequent peak.
Center of Pressure (CoP) Post Perturbation Variability
时间窗: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: \- The standard deviation (SD) of the CoP anterior-posterior displacement over a 2.5-second time window from the beginning of the perturbation as the post perturbation variability (PPV), measured in centimeters.
次要结局
- 10-meter walking test(At baseline (t0), after six weeks (t1) and after 12 weeks (t2))
- Timed Up and Go (TUG) test(At baseline (t0), after six weeks (t1) and after 12 weeks (t2))