The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills and Behavior (BiPerAge): a Single Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 127
- 试验地点
- 4
- 主要终点
- Number of faults in the cycling course
研究概览
简要总结
The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while sitting. With this system, unexpected perturbations can be provided under controlled and safe conditions. Within the BiPerAge-project it will be evaluated if 20 training sessions (20 minutes each) on the PerStBiRo system will lead to transfer effects on safe cycling skills of community-dwelling older adults (age 65 years and older). The ability to cycle safely will be tested prior and after the training period using a cycling course, which consists of variant tasks requiring motor and cognitive skills.
详细描述
Cycling is a form of physical activity that is positively associated with health and functional benefits. However, there is a significant association between increased bicycle use and bicycle accidents with higher risks of severe injuries especially for older adults. This could be partly explained by deterioration of the balance control during aging. On the one hand, training of balance-challenging situations in daily traffic situation is hardly possible under "real-world" conditions for safety reasons. On the other hand, the use of a stationary bicycle alone has not been shown to specifically train balance skills and cycling competence. To overcome this issue the Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while riding in a controlled and safe condition.
The main and overarching objective of our proposed project is to investigate transfer effects of a training on the PerStBiRo system with perturbation (PerTSBR - intervention group) on cycling competence of community-dwelling older adults (age 65 years and older) in comparison to a training on the same system without perturbation (TSBR - active control group). The cycling competence as our primary outcome will be measured by a standardized cycle course before and after the 3 months intervention period. The cycle course, which is validated in a recent study (SiFAr) of our research group, consists of various tasks requiring motor and cognitive skills related to traffic situations in daily life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome measures will be obtained by two research assistants in each country who are blinded to group allocation. Participants will not fully be blinded to group allocation since they notice whether perturbation occur during training. However, both groups will be told that the primary aim of the study is to improve cycling skills by training on an indoor, stationary bicycle.
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and willingness to provide informed consent and accept randomization to either study arm
- •Ability to come to cycle course testing locations
- •≥3 errors in pre-test of cycle course
排除标准
- •Severe diseases e.g. ischemic heart disease which restricts exercise, chronic obstructive pulmonary disease (COPD), uncontrolled blood pressure, manifest osteoporosis or any other disease leading to increased fracture risks
- •A period less than one year after hip or knee replacement surgery or after fractures of the lower extremities
- •Amputation of a lower limb
- •Neurological diseases or 6-month after a stroke
- •Inability to ambulate independently
- •Severe visual impairments (blindness), non-compensable hearing
- •Cognitive impairment, scoring less than 24 on the MMSE (Mini-Mental State Examination), inability to understand and follow instructions
- •Participation in another intervention trial at the same time or within the previous 6 months
结局指标
主要结局
Number of faults in the cycling course
时间窗: changes over a period of 3 months and after a follow-up period of 6-9 months
The cycling competence will be tested in a standardized cycling course, including the following tasks: slalom, slow cycling within a marked lane, dismounting into a marked zone, getting on the bike, cycling through a narrow alley, turning to the off-side, braking with pinpoint accuracy. Mean change of number of faults in the cycling course will be tested between pre- and postintervention.
次要结局
- Balance Error Scoring System (BESS)(changes over a period of 3 months and after a follow-up period of 6-9 months)
- 5 Chair Stand Test(changes over a period of 3 months and after a follow-up period of 6-9 months)
- Four Square Step Test(changes over a period of 3 months and after a follow-up period of 6-9 months)