Short-term Neurophysiological Changes After a Perturbation-based Training in Community-dwelling Older Adults: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Gray matter density in arbitrary units by structural Magnetic Resonance Imaging
研究概览
简要总结
This is an assessor-blinded neurophysiological study. Participants will be randomly assigned to a perturbation-based training (PBT) or a walking (control) group. Changes in postural stability and neurophysiology in the brain following PBT compared to walking exercise without perturbation will be investigated.
详细描述
A total of 88 participants will be randomly assigned to two groups receiving perturbation-based training (PBT) or walking exercise without perturbation (control). Written informed consent will be obtained from participants prior to the baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenience sampling in the local community. Both groups will receive two sessions of treadmill walking at their comfortable speed. Perturbations will be induced during treadmill walking only for the PBT group. As informed from previous literature, two sessions of PBT could have improved postural stability for up to 1.5 years. Between-group differences in behavioural and MRI findings will be examined before and after training to identify training-induced changes in postural stability, brain structures, and functional connectivities. Retention of the changes in the postural stability will be assessed four months after the training period. Incidents of falls will be followed up for 12 months after training.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 60 years old
- •Community-dwelling
- •Right-handed
- •Able to communicate effectively in Cantonese or Mandarin
- •Able to walk independently on level ground for ≥ 30 minutes
- •Abbreviated Mental Test (Hong Kong version) score ≥ 6
排除标准
- •Metal implants (e.g. pacemaker, artificial cochlea)
- •Uncorrected vision or hearing impairment
- •Osteoporosis
- •Hip or knee replacement within the last year
- •Musculoskeletal, cardiovascular, mental, or neurological disorders (such as Parkinson's disease) which can affect MRI examination, balance control, or exercise participation.
结局指标
主要结局
Gray matter density in arbitrary units by structural Magnetic Resonance Imaging
时间窗: pre-intervention, and within 1-week after the intervention
Gray matter density at cortical and subcortical regions will be taken by structural MRI. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
Brain connectivity derived from the correlation between the Blood-oxygen-level-dependent (BOLD) signals from different brain regions in arbitrary units obtained during functional MRI
时间窗: pre-intervention, and within 1-week after the intervention
BOLD signal reflecting the brain connectivity during rest will be taken through resting-state functional MRI, during which subjects are instructed to relax with eyes open, to let their mind wander, and not think of anything specific. The regions of interest include the cerebellum, basal ganglia, thalamus, hippocampus, inferior parietal cortex, occipital and frontal lobe.
次要结局
- Postural stability(pre-intervention, within 1 week after intervention and 4 months after intervention)
- Number of laboratory-falls(pre-intervention, within 1 week after intervention and 4 months after intervention)
- Number of real-life-falls(1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.)
- Step time of the recovery steps in milliseconds (ms)(pre-intervention, within 1 week after intervention and 4 months after intervention)
- Step length of the recovery steps in millimeters (mm)(pre-intervention, within 1 week after intervention and 4 months after intervention)
- Trunk angle(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Hip height in millimeters (mm)(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Responsive postural adjustment upon translation(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Responsive postural adjustment upon tilting(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Muscle activation onset latency in milliseconds(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Balance confidence(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention, and at the last prospective fall follow-up)
- Cognitive flexibility and executive function(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- Functional lower body strength(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- Dynamic balance(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- Mobility(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- White matter density in arbitrary units by structural Magnetic Resonance Imaging(pre-intervention, and immediately after the intervention)
- Gray matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)(pre-intervention, and immediately after the intervention)
- White matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)(pre-intervention, and immediately after the intervention)
- Cortical thickness in mm measured by structural Magnetic Resonance Imaging(pre-intervention, and immediately after the intervention)
- Fractional anisotropy ranges from 0-1 derived from Diffusion Tensor Imaging(pre-intervention, and immediately after the intervention)
- Mean diffusivity measures in mm²/s by Diffusion Tensor Imaging(pre-intervention, and immediately after the intervention)
- Number of real-life-falls(1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.)
- Trunk angle(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Hip height in millimeters (mm)(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Responsive postural adjustment upon tilting(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Muscle activation onset latency in milliseconds(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Responsive postural adjustment upon translation(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention)
- Balance confidence(pre-intervention, immediately after the intervention, 1 week after intervention and 4 months after intervention, and at the last prospective fall follow-up)
- Cognitive flexibility and executive function(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- Functional lower body strength(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- Dynamic balance(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- Mobility(pre-intervention, immediately after the intervention, 1 week after intervention, and 4 months after intervention)
- White matter density in arbitrary units by structural Magnetic Resonance Imaging(pre-intervention, and immediately after the intervention)
- Gray matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)(pre-intervention, and immediately after the intervention)
- White matter volume in cubic millimeters (mm³) by structural Magnetic Resonance Imaging (MRI)(pre-intervention, and immediately after the intervention)
- Cortical thickness in mm measured by structural Magnetic Resonance Imaging(pre-intervention, and immediately after the intervention)
- Fractional anisotropy ranges from 0-1 derived from Diffusion Tensor Imaging(pre-intervention, and immediately after the intervention)
- Mean diffusivity measures in mm²/s by Diffusion Tensor Imaging(pre-intervention, and immediately after the intervention)