Treadmill Training in Fragile X-associated Tremor/Ataxia Syndrome
关键词
抽象
描述
There is substantial evidence that physical exercise can improve motor and cognitive function in individuals with Parkinson's Disease, traumatic brain injury or chronic stroke survivors. However, to the investigator's knowledge, no studies have explored the effect of treadmill training with or without a cognitive dual Task on gait, balance and cognition in Fragile X - Associated Tremor/Ataxia Syndrome (FXTAS), which is characterized by action tremor, cerebellar gait ataxia, parkinsonism, peripheral neuropathy and cognitive deficits, all of which increase the risk for falls and progressive disability. There are presently no medications or treatment interventions that have been shown to effectively manage the symptoms of FXTAS or delay disease progression, and it is currently not clear whether either the ST or Dual-Task treadmill training paradigms would be feasible or effective in FXTAS.
A total of 10 individuals with FXTAS will recruited from the Rush University Movement Disorders Clinic or the FXTAS Clinic Database at Rush University. The subjects will be assigned to either 6 weeks of dual-task treadmill exercise training combined with a cognitive task (intervention group) occurring 3 times weekly, or control group. The primary outcome measures will be feasibility, safety and patient adherence. The assessments will occur at baseline, week 3, week 6, 1 month & 6 month post-training.
日期
最后验证: | 05/31/2020 |
首次提交: | 09/30/2019 |
提交的预估入学人数: | 06/09/2020 |
首次发布: | 06/10/2020 |
上次提交的更新: | 06/09/2020 |
最近更新发布: | 06/10/2020 |
实际学习开始日期: | 07/29/2019 |
预计主要完成日期: | 07/29/2021 |
预计完成日期: | 12/30/2021 |
状况或疾病
干预/治疗
Behavioral: Treadmill Exercise + Cognitive Training (Dual-Task)
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Treadmill Exercise + Cognitive Training (Dual-Task) The Dual-Task group will be provided with treadmill training with added simultaneous cognitive training during treadmill exercise training. | Behavioral: Treadmill Exercise + Cognitive Training (Dual-Task) The dual-task regimen will include treadmill exercise of 5-10 min warm-up and cool-down, 30 minutes of running towards target heart rate, combined with respond demands with the addition of cognitive tasks. The level of duration and intensity of treadmill exercise will progressively increase over the duration of 6 weeks. |
No Intervention: Control Group The control group will be assessed as the intervention group at the same time intervals without the intervention. |
资格标准
有资格学习的年龄 | 50 Years 至 50 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - A diagnosis of possible, probable or definite FXTAS - Able to stand and walk without support for 2 minutes Exclusion Criteria: - Any neurologic or musculoskeletal problems - History of traumatic brain injury - Significant cardiopulmonary or cardiovascular disease - Dementia or other significant cognitive impairment - Unstable psychiatric disorders |
结果
主要结果指标
1. High levels of program attendance, and retention [6 weeks]
2. High levels of satisfaction [6 weeks]
3. High levels of recruitment [6 months]
次要成果指标
1. Change in balance and mobility measured by Instrumented-SWAY (i-SWAY) [6 weeks]
2. Change in functional mobility measured by Instrumented-WALK (i-WALK) [6 weeks]
3. Change in balance and mobility measured by Mini-BEST balance scale [6 weeks]
4. Change in patient reported confidence in balance measured by Activities-Specific Balance Confidence Scale (ABC) [baseline, week 6, post-training month 1 & month 6]
5. Change in cognitive function measured by the Montreal Cognitive ASsessment (MoCa) [6 months]
6. Change in cognitive function measured by the Symbol Digit Modalities Test (SDMT) [6 weeks]
7. Change in cognitive function measured by Controlled Oral Word Association Test (COWAT) [6 weeks]
8. Change in cognitive function measured by (STROOP) [6 weeks]
9. Change in cognitive function measured by Digit Span forward and backward test [6 weeks]
10. Change in health related quality of life measured by the Neuro Quality of Life Survey [6 months]
11. Change in depression measured by the Center for Epidemiologic Studies Depression Scale (CES-D) [6 weeks]
12. Change in quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire [6 weeks]
13. Change in perceived exertion on physical activity intensity measured by the Borg Rating Scale (Borg Rating of Perceived Exertion Scale) [6 weeks]
14. Change in physical activity level measured step counts monitored by Fitbit wrist watch [6 weeks]
15. Change in anxiety measured by the Beck Anxiety Inventory (BAI). [6 weeks]