Treadmill Training in Fragile X-associated Tremor/Ataxia Syndrome

NCT04428567 | Terminated DMC

• 1 other identifier: 18200205
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Fragile X Associated Tremor-ataxia Syndrome

Keywords

Dual-task; feasibility; FXTAS; treadmill training

Outcome Measures

Primary Outcomes (3)

• High levels of program attendance, and retention

  At each study visit the subjects attend and revisit were taken down throughout the entire intervention period in an attendance/retention log book.

  6 weeks

• High levels of satisfaction

  At the end of the entire study a client satisfaction questionnaire was administered and interpreted based on a percent of satisfaction, ranging from zero to one hundred percent, on various satisfactory questions. Zero percent meaning highly unsatisfied and one hundred percent meaning highly satisfied.

  6 weeks

• High levels of recruitment

  Research subjects were recruited using a recruitment flyer for the study and tracked by the number of willing participants.

  6 months

Secondary Outcomes (15)

• Change in balance and mobility measured by Instrumented-SWAY (i-SWAY)

  6 weeks

• Change in functional mobility measured by Instrumented-WALK (i-WALK)

  6 weeks

• Change in balance and mobility measured by Mini-BEST balance scale

  6 weeks

• Change in patient reported confidence in balance measured by Activities-Specific Balance Confidence Scale (ABC)

  baseline, week 6, post-training month 1 & month 6

• Change in cognitive function measured by the Montreal Cognitive ASsessment (MoCa)

  6 months

Study Arms (2)

Treadmill Exercise + Cognitive Training (Dual-Task)

EXPERIMENTAL

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

Behavioral: Dual-Task Treadmill exercise + Cognitive Training

Control Group

NO INTERVENTION

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

Interventions

Dual-Task Treadmill exercise + Cognitive Training 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.

Treadmill Exercise + Cognitive Training (Dual-Task)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of possible, probable or definite FXTAS
• Able to stand and walk without support for 2 minutes

You may not qualify if:

• Any neurologic or musculoskeletal problems
• History of traumatic brain injury
• Significant cardiopulmonary or cardiovascular disease
• Dementia or other significant cognitive impairment
• Unstable psychiatric disorders

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Kellogg Building 1625 W. Harrison St. Room 235

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Fragile X Tremor Ataxia Syndrome

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joan A O'Keefe, PhD, PT

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: June 11, 2020
• Study Start: July 30, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (1)