Multimodal Exercise Programs for Fall Prevention - Psychomotor Versus Psychomotor Combined With Whole-Body Vibration: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline, between and within groups comparison, in Executive Function
研究概览
简要总结
The aim of present study is to analyze and compare the effect of two exercise programs - psychomotor exercise program vs exercise combined program (psychomotor + whole body vibration) - on risk factors for falls of community-dwelling older adults who are fallers or are "at high risk of falling".
This experimental study is a randomized controlled trial. The program will run for 24 weeks (3 sessions / week of 75 minutes), followed by 12 weeks of follow-up without intervention. Participants of the groups will be assessed 1) at baseline, 2) at 12 weeks, 3) at 24 weeks, and 4) after the follow-up. Participants will be randomly allocated to three groups: experimental group 1 (psychomotor program); experimental group 2 (combined program) and control group.
详细描述
Aging is associated with a decline in executive functions, negatively influencing the motor, social and emotional capacities of older adults. (1) These losses will contribute to increase the risk of falling, so much that most falls occur during the performance of a dual-task (DT) (2).
The lack of balance, strength and poor body composition are seen as causes of falls, and should therefore be considered in the prevention programs of these events in older adults. (3-5) A psychomotor exercise program uses the body and movement as mediators, relying on the prevention of cognitive, sensory, perceptive, emotional and affective deterioration, exploring the neuroplasticity. (6,7) Therefore, this sensorimotor and neurocognitive program may prevent falls, but it is important to analyze its real impact in reducing either falls or the risk factors for falls in the older adults. No studies focusing on this subject were found.
The intervention through the whole body vibration (WBV) is referred in the literature as promoting the improvement of balance, mobility and agility, and preventing falls in the older adults.(8,9) WBV will have long-term therapeutic effects promoting the increase of muscle strength and increased bone mineral density. (10) Being two intervention methods with potential good results on falls prevention, it is not known whether there will be additional benefits in an intervention that combines both methods.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged ≥65 years;
- •Community-dwelling older adults;
- •Older adults who have fallen in the last 6 months or who are at high risk of falling (scoring ≤25 points on Fullerton Advanced Balance Scale);
- •Participation agreement;
排除标准
- •Presence of severe cognitive decline (patients with a Mini-Mental State Examination ≤9);
- •Fracture in one or both lower limbs for less than 4 months;
- •Diagnosed of health conditions compromising the program participation, such as: severe osteoporosis (T ≤ 2.5, with the occurrence of one or more associated osteoporotic fractures); hip or knee prostheses; incapacitating cardiovascular conditions; epilepsy; cancer or metastases;
- •Do not wish to participate in the study;
研究组 & 干预措施
Psychomotor exercise program
The experimental group 1 (EG1) intervention comprises a psychomotor program. The program integrates 3 sessions / week of 75 minutes on alternated days. The psychomotor intervention includes exercises promoting simultaneous motor and cognitive stimulation (interval training).
干预措施: Psychomotor exercise program (Other)
Combined exercise program
The experimental group 2 (EG2) intervention combines the psychomotor program with a WBV program. The program integrates 3 sessions / week of 75 minutes (including the 6 minutes of WBV) on alternated days.
干预措施: Combined exercise program (Other)
Control Group
Usual care. After the study, control group (CG) participants will be offered the opportunity to integrate a similar fall prevention program.
结局指标
主要结局
Change from Baseline, between and within groups comparison, in Executive Function
时间窗: 0,3,6,9 months
Outcome Measure - Trial Making Test (Part A and B) to assess information processing speed
Change from Baseline, between and within groups comparison, in Physical Performance
时间窗: 0,3,6,9 months
Outcome Measure - Biodex (Peak Torque) to assess lower-body strength
Change from Baseline, between and within groups comparison, in Body Composition
时间窗: 0,3,6,9 months
Outcome Measure - Dual-energy X-ray Absorptiometry to assess body fat mass (%) and body lean mass (%)
Fall occurrence in the previous 6 months at baseline and at post-intervention
时间窗: 0,6 months
Comparasion of the number of falls between and within groups
次要结局
- Borg Rating of Perceived Exertion(0-6 months)
- Mini-Mental State Examination(0 months)
- Composite Physical Function scale(0 months)
- International Physical Activity Questionnaire(0 months)
研究者
Hugo Filipe Zurzica Rosado
MSc
University of Évora