Treadmill Training in Fragile X-associated Tremor/Ataxia Syndrome
Keywords
Abstract
Description
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.
Dates
Last Verified: | 05/31/2020 |
First Submitted: | 09/30/2019 |
Estimated Enrollment Submitted: | 06/09/2020 |
First Posted: | 06/10/2020 |
Last Update Submitted: | 06/09/2020 |
Last Update Posted: | 06/10/2020 |
Actual Study Start Date: | 07/29/2019 |
Estimated Primary Completion Date: | 07/29/2021 |
Estimated Study Completion Date: | 12/30/2021 |
Condition or disease
Intervention/treatment
Behavioral: Treadmill Exercise + Cognitive Training (Dual-Task)
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
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. |
Eligibility Criteria
Ages Eligible for Study | 50 Years To 50 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | 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 |
Outcome
Primary Outcome Measures
1. High levels of program attendance, and retention [6 weeks]
2. High levels of satisfaction [6 weeks]
3. High levels of recruitment [6 months]
Secondary Outcome Measures
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]