Treadmill Training in Fragile X-associated Tremor/Ataxia Syndrome (FXTAS)

Rush

Status: Terminated

Conditions: Fragile X Associated Tremor-ataxia Syndrome

Treatments: Behavioral: Dual-Task Treadmill exercise + Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04428567

18200205

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3 participants in 2 patient groups

Treadmill Exercise + Cognitive Training (Dual-Task)

Experimental group

Description:

The Dual-Task group will be provided with treadmill training with added simultaneous cognitive training during treadmill exercise training.

Treatment:

Behavioral: Dual-Task Treadmill exercise + Cognitive Training

Control Group

No Intervention group

Description:

The control group will be assessed as the intervention group at the same time intervals without the intervention.