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临床试验/NCT03636672
NCT03636672已完成不适用

The Effects of Bicycle Simulator Training on Anticipatory and Compensatory Postural Control in Older Adults: A Randomized Controlled Trial

Barzilai Medical Center1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Compensatory Step Execution tests during Standing and Walking

研究概览

简要总结

A Randomized Control Trial will be conducted with Independent old adults (age 70 years old and older) who willing to participate in the study. They will be randomly allocated to two groups: 1) Stationary bicycle riding that includes perturbation balance training during riding; 2) Stationary bicycle riding that does not includes perturbation balance training during riding. Balance and Gait assessments will be tested before and after 3 months of training (2-3 times a week).

详细描述

Falls and fall-related injuries are common elder health problems. Falls are the leading cause of fatal and nonfatal injuries among older adults, reducing mobility and independence, and increase the risk of death. Between 30 to 40% of the community-dwelling older persons fall at least once a year, usually by falling sideways that is resulting in 95% of hip fractures. In the U.S. in 2014, the estimated direct medical costs for fall-related injuries were $31.3 billion and is expected to reach $67.7 billion by 2030 Age-related changes in the balance control system increase the risk of falls. Execute a rapid step, whether voluntary or compensatory, is the most important balance strategy to prevent a fall. In voluntary stepping test, the foot contact times (i.e., stepping time) and reaction time (initiation phase) were able to predict future fall and injury from fall. Studies of the reactive postural control have shown that older adults initiate stepping at lower levels of instability, use multiple steps, experience leg collisions or fail to recover balance compared to younger adults. The Medio-Lateral center of pressure sway range with Eyes Closed is the best single predictor for future fall.

Studies showed that older adults were able to adapt in a reactive manner after participation in a Perturbations based balance training (PBBT) that challenged the mechanisms responsible for dynamic stability. These studies also showed a reducing in rate of falls and diverse risks of falls in older adults (voluntary stepping times, balance control in standing and walking, improved function and reduced fear of falls). however, in these studies the training devices and programs were designed to participants who able to walk independently the whole training sessions, lasting 20-45 minutes each and appropriate only for a small portion of the general elderly population. In fact, in 2014 in U.S., the community-dwelling older persons that reported a fall were divided equally into three health status: poor-fair, good, very good-excellent with 33% rate of fall each subgroup. This fact motivates us to provide accessibility PBBT for a wider range of the elderly population, and not for the "strongest" older subjects.

Inspired by the well-known health advantages of cycling and the medio-lateral postural control demand during two-wheel bicycle riding, encourage us to conduct a preliminary study for feasibility. In this study we found older adults who aged with bicycle riding habits have benefits in reactive and predictive aspects of postural control mechanisms (particularly in the medio-lateral postural control) while standing and stepping, both related to risk of falling in the elderly (see Preliminary result section). Because the special importance of the medio-lateral balance control for preventing lateral falls and hip fractures in old age, considering our preliminary findings, we hypothesize that following exposure to training program that includes unexpected perturbations exercises during cycling will significantly improve compensatory and voluntary stepping times as well as the medio-lateral balance control in older adults, factors that are associated with falls and fall- related injuries.

Objectives: firstly, to explore whether training while riding a new bicycle simulator device providing unexpected perturbations can reduce risks of falls in standing and walking in independent older adults. Secondly, if so, to examine this bicycle simulator device providing unexpected perturbations method in a wider range of elderly subjects (i.e., who do not walk independently or walk for only short distances or with assisted devices or suffering from fear of falling or in pre-walking rehabilitative phases after stroke or other morbidity).

Methods Study design: A double blinded randomized controlled trial. Participants: Relatively healthy Community dwelling older adults that are 70 years or older, independent in daily living activities, walking without assistive devices, without morbidity that influence balance performance. The study will be approved by the Helsinki committee of Barzilai University medical center, Ashkelon, Israel. All subjects will sign an informed consent statement.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
70 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age 70 and over
  • •able to walk independently
  • •The provision of a medical certificate from the family physician allowing participation in physical training that requires walking two or three times a week.

排除标准

  • •suffers from ischemic heart disease which will restrict exercise and chronic obstructive pulmonary disease and uncontrolled blood pressure;
  • •severe vision problems (blindness);
  • •mini-mental score of 24 or more;
  • •At least one year after hip or knee replacement surgery or after fractures of the lower extremities;
  • •Amputation on the lower limb.
  • •neurological diseases or after a stroke

研究组 & 干预措施

experimental

Experimental

Perturbation training during stationary bicycle riding

干预措施: perturbation training (Procedure)

control

Active Comparator

stationary bicycle riding training

干预措施: perturbation training (Procedure)

结局指标

主要结局

Compensatory Step Execution tests during Standing and Walking

时间窗: change from baseline to 3 months later

the time from perturbation to foot contact the floor completing the recovery stepping will be measured in milliseconds

次要结局

  • Postural Sway measure using force plate(change from baseline to 3 months later)
  • Berg Balance Scale(change from baseline to 3 months later)
  • 6-minute walk test (6MWT);(change from baseline to 3 months later)
  • Late Life Function and Disability Instrument (LLFDI);(change from baseline to 3 months later)
  • Falls Efficacy Scale-International(change from baseline to 3 months later)
  • Voluntary Step Execution Test(change from baseline to 3 months later)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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