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Treadmill Training in Fragile X-associated Tremor/Ataxia Syndrome

NCT ID: NCT04428567

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2020-03-30

Brief Summary

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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

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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.

Conditions

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Fragile X Associated Tremor-ataxia Syndrome

Keywords

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Dual-task feasibility FXTAS treadmill training

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dual-Task Treadmill exercise + Cognitive Training

Intervention Type BEHAVIORAL

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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dual-Task Treadmill exercise + Cognitive Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan A O'Keefe, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Kellogg Building 1625 W. Harrison St. Room 235

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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18200205

Identifier Type: -

Identifier Source: org_study_id