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Clinical Trials/NCT06799429
NCT06799429RecruitingNot Applicable

Train Your Brain Fitness SC: An Exercise Intervention for People With Cognitive Impairments

University of South Carolina2 sites in 1 country50 target enrollmentStarted: March 13, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
2
Primary Endpoint
Aim 1 Feasibility: Recruitment and Uptake through qualified referrals

Study Overview

Brief Summary

The goal of this clinical trial is to test a twice a week, moderate intensity exercise and coaching program (an in-person group and a distance group) for adults with mild-moderate cognitive impairments living in South Carolina. The main questions it aims to answer are:

  1. Is the program practical to conduct, and it is acceptable and enjoyable? The hypothesis is that it will be possible to recruit participants, obtain the desired dosage of moderate intensity fitness and strength training twice a week for both groups.
  2. Are their changes at 3, 6, 9 and 12 months in endurance, mobility, cognitive function and perception of cognitive function? The hypotheses are that endurance, strength and mobility will improve and cognitive measures will not decline (remain the same or improve) for both groups.

Detailed Description

In person Exercise Group (Columbia, SC):

The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist). The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will attend two times per week. Study coaches will provide exercise plans, and monitor and provide feedback as participants exercise. Participants will wear a heart rate monitor to record exertion and coaches will record exercise and intensity in online coaching software.

Distance Exercise Group: (Sumter, SC):

The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist) which will occur in person. The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Coaches will prescribe an exercise program that can be performed at a local fitness facility and it will be shared through a coaching software or paper log. Participants will have in-person fading facility personal trainer support for 7 visits in the first 12-weeks and complete the remaining twice weekly exercise on their own. Participants will log their exercises and intensity either in the coaching software or in paper formats, have bi-weekly check-ins with fitness center coaches and have options to message the fitness center coaches with questions.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •adult (age >18)
  • •medical diagnosis of mild-moderate cognitive impairment
  • •medical clearance by referring provider for exercise
  • •able to follow 2-step commands

Exclusion Criteria

  • •significant pain with movement (>5/10)
  • •severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgment at Intake)

Arms & Interventions

In-Person Group

Experimental

For the supervised in-person group, all activities will be performed at the Train Your Brain Fitness Center in Columbia, SC. Participants will have real-time coaching and feedback from study coaches for each of the twice weekly exercise (up to 120 minutes weekly).Coaches will record exercises and intensity.

Intervention: Supervised Exercise and Behavior Modification Support (Behavioral)

Distance Group

Experimental

For the monitored distance group, all activities will be performed at a fitness facility near their home with prescribed plans provided by a study coach. These individuals will have support from a fitness facility personal trainer to complete the prescribed exercises for up to 7 visits in the first 12 weeks. They will perform the remaining twice weekly exercise (up to 120 minutes weekly) on their own and record the information in electronic or paper logs.

Intervention: Monitored Exercise and Behavioral Modification Support (Behavioral)

Outcomes

Primary Outcomes

Aim 1 Feasibility: Recruitment and Uptake through qualified referrals

Time Frame: through study completion, an average of 1 year

percent of qualified referrals beginning the program

Aim 1 Feasibility: Acceptability: Participant Satisfaction

Time Frame: through study completion, an average of 1 year

mean of 5 point likert scale 1-not satisfied to 5-extremely satisfied

Aim 1 Feasibility: Program Fidelity Dosage: session adherence

Time Frame: through study completion, an average of 1 year

mean percentage adherence (number of sessions completed / number of sessions scheduled)

Aim 1 Feasibility: Program Fidelity Dosage: Session Duration

Time Frame: through study completion, an average of 1 year

mean percentage duration

Aim 1 Feasibility: Program Fidelity: Exercise Intensity

Time Frame: through study completion, an average of 1 year

mean percent of time spent in target heart rate zone of 60-85% of age predicted maximum

Aim 2 Exploratory Individual Outcomes: Processing Speed and Executive Function through the Oral Symbol Digits Test (NIH Toolbox)

Time Frame: pre-program (baseline), 3, 6 9 and 12 months

Score is number of correct responses (0-144), with higher score as better performance

Aim 2 Exploratory Individual Outcomes: Cardiovascular Endurance through the six-minute walk test

Time Frame: pre-program (baseline), 3, 6 9 and 12 months

Score is meters walked, higher is better performance

Aim 2 Exploratory Individual Outcomes: Working Memory through the Auditory Verbal Learning Test (NIH Toolbox)

Time Frame: pre-program (baseline), 3, 6 9 and 12 months

Score is number of correct responses (0-45), with higher score as better performance

Secondary Outcomes

  • Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery(pre-program (baseline), 3, 6 9 and 12 months)
  • Aim 2 Exploratory Individual Outcomes: Grip Strength using a hand-held grip dynamometer (lbs. of force)(pre-program (baseline), 3, 6 9 and 12 months)
  • Aim 2 Exploratory Individual Outcomes: Perception of cognition through the Patient-Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Testing survey(pre-program (baseline), 3, 6 9 and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Regan

Clinical Associate Professor

University of South Carolina

Study Sites (2)

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