Exercise With and Without Cognitive Training

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT07447115
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Effect of Exercise with and Without Cognitive Training on Gait — BEHAVIORAL
    This behavioral trial aims to determine the effect of exercise with and without computerized cognitive training on gait in older Veterans with Multiple Sclerosis.

Study Details

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.

Key Dates

Start date
Jan 4, 2027
Status verified
Feb 2026
Primary completion
Jan 4, 2028
Completion
May 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Computerized Cognitive Training
    This 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 Comparator: Active Control
    This 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.

Primary Outcome Measure

Gait speed [ Time Frame: Baseline & 10-week Follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Joe R Nocera, PhD
404-321-6111
Katherine Hsieh, PhD (PRINCIPAL_INVESTIGATOR)

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