Clinical trial NCT04428567: Treadmill Training in Fragile X-associated Tremor/Ataxia Syndrome
Official title: A Pilot Dual-Task Treadmill Training to Improve Gait and Balance in Fragile X-Associated Tremor/Ataxia Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fragile X Associated Tremor-ataxia Syndrome
Keywords: Dual-task
feasibility
FXTAS
treadmill training
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects will be randomly assigned to 2 groups: 1) treadmill training group with a cognitive task (Intervention group) 2) Control group. The entire intervention period is 6 weeks in both groups, with interventional training occurring 3 days per week for approximately 45 minutes per session. Evaluations will take place at baseline, 3 weeks, at the end of 6 weeks, and 1 month and 6 months after the intervention.
Primary purpose: TREATMENT

Brief summary: A pilot trial to determine the feasibility of treadmill training with dual training in patients with Fragile X-Associated Tremor/Ataxia Syndrome (FXTAS).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: High levels of program attendance, and retention
timeFrame: 6 weeks
measure: High levels of satisfaction
timeFrame: 6 weeks
measure: High levels of recruitment
timeFrame: 6 months
Secondary outcomes:
measure: Change in balance and mobility measured by Instrumented-SWAY (i-SWAY)
timeFrame: 6 weeks
measure: Change in functional mobility measured by Instrumented-WALK (i-WALK)
timeFrame: 6 weeks
measure: Change in balance and mobility measured by Mini-BEST balance scale
timeFrame: 6 weeks
measure: Change in patient reported confidence in balance measured by Activities-Specific Balance Confidence Scale (ABC)
timeFrame: baseline, week 6, post-training month 1 & month 6
measure: Change in cognitive function measured by the Montreal Cognitive ASsessment (MoCa)
timeFrame: 6 months
measure: Change in cognitive function measured by the Symbol Digit Modalities Test (SDMT)
timeFrame: 6 weeks
measure: Change in cognitive function measured by Controlled Oral Word Association Test (COWAT)
timeFrame: 6 weeks
measure: Change in cognitive function measured by (STROOP)
timeFrame: 6 weeks
measure: Change in cognitive function measured by Digit Span forward and backward test
timeFrame: 6 weeks
measure: Change in health related quality of life measured by the Neuro Quality of Life Survey
timeFrame: 6 months
measure: Change in depression measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6 weeks
measure: Change in quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: 6 weeks
measure: Change in perceived exertion on physical activity intensity measured by the Borg Rating Scale (Borg Rating of Perceived Exertion Scale)
timeFrame: 6 weeks
measure: Change in physical activity level measured step counts monitored by Fitbit wrist watch
timeFrame: 6 weeks
measure: Change in anxiety measured by the Beck Anxiety Inventory (BAI).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Kellogg Building 1625 W. Harrison St. Room 235
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Joan A O'Keefe, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: