Exercise With and Without Cognitive Training
The Effect of Exercise With and Without Cognitive Training on Gait in Older Veterans With Multiple Sclerosis
2 other identifiers
interventional
30
1 country
1
Brief Summary
This proposal aims to conduct a 10-week randomized controlled trial comparing walking and resistance training with and without computerized cognitive training in older Veterans with Multiple Sclerosis, followed by 12 months of fall tracking with sensors and fall calendars. The primary objectives of this proposed CDA2 are to provide critical preliminary data on 1) the feasibility of conducting a 10-week RCT, 2) preliminary treatment effects on gait, cognition, and falls, and 3) neuroinflammatory biomarkers. Dr. Katherine Hsieh will receive hands-on training in the design and conduct of clinical trials (Dr. Hackney), mechanisms underlying physical activity, cognitive rehabilitation, and falls (Drs. Twamley, Hackney, \& Kesar), fall detection technology (Prof. Sanford), and clinical problems faced by MS participants (Dr. Backus) to achieve her long-term career goal of becoming an independent falls prevention investigator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Jan 2027
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
January 4, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2028
Study Completion
Last participant's last visit for all outcomes
May 1, 2028
March 3, 2026
February 1, 2026
1 year
February 25, 2026
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Gait speed
Participants will walk 10m at their usual and fast speeds to measure gait speed in meters/second.
Baseline & 10-week Follow-up
Exit questionnaire
Satisfaction will be examined with an exit questionnaire that uses a Likert questionnaire (5 point scale) to assay enjoyment of the intervention, willingness to continue with the intervention should participants have the opportunity and whether the participants noted improvement in aspects of well being, e.g., mood, quality of life, mental activity, physical activity, and whether the participants noted improvement in motor function, eg gait, balance, strength, etc.
10-week Follow-up
Secondary Outcomes (10)
Static Postural Control
Baseline & 10-week Follow-up
Symbol Digit Modality Test
Baseline & 10-week Follow-up
California Verbal Learning Test
Baseline & 10-week Follow-up
Falls efficacy scale (FES)
Baseline & 10-week Follow-up
Number of falls per month
1 year follow up after intervention, e.g., at 15 months.
- +5 more secondary outcomes
Study Arms (2)
Computerized Cognitive Training
EXPERIMENTALThis group will complete 75 minutes of walking and resistance exercises followed by computerized cognitive training. Exercises will include treadmill walking and resistance training using bodyweight, dumbbells, and/or bands, following guidelines from the National MS Society. Progression and intensity will be individualized and gradual over time. Sessions are 3x per week for 10 weeks. After a cool-down, participants will use RehaCom for 30 minutes. Cognitive modules will progress in difficulty and tailored. Modules will target attention, executive function, logical reasoning, and memory.
Active Control
ACTIVE COMPARATORThis group will complete the same exercises as the experimental group. After their cool-down, they will use a computer for 30 minutes to play puzzle games. These games were not developed to provide cognitive rehabilitation. Games will vary each session.
Interventions
This behavioral trial aims to determine the effect of exercise with and without computerized cognitive training on gait in older Veterans with Multiple Sclerosis.
Eligibility Criteria
You may qualify if:
- US Veteran
- Diagnosis of Multiple Sclerosis
- Relapse free in the last 30 days
- Capable of standing unaided for at least 1 minute
- Expanded Disability Status Scale \<6.5
- Ability to speak and understand English
You may not qualify if:
- Any neurological disorder other than MS
- Modified Telephone Interview for Cognitive Status \<20
- Current participation in an exercise or cognitive rehabilitation study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Hsieh, PhD
Atlanta VA Medical and Rehab Center, Decatur, GA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is a double-blinded randomized controlled trial. (RCT) Outcome assessors and participants will not know which group they are randomized to.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 3, 2026
Study Start (Estimated)
January 4, 2027
Primary Completion (Estimated)
January 4, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share