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NCT Number: NCT06799429

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

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.

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Key information

Conditions

Mild-moderate Cognitive Impairment Behavior Cognition Disorders Cognitive Dysfunction Mental Disorders Motor Activity Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arnold School of Public Health, Columbia, South Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Supervised Exercise and Behavior Modification Support

Behavioral

The exercise intervention will have a goal of up to minutes (60 minutes 2 x a week) of moderate intensity exercise building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity, 30-60 minutes of functional strength training targeting major muscle groups (to include at a minimum: a squat movement, an upper extremity push movement, an upper extremity pull movement, a carry movement, a stepping movement and a trunk stabilization movement), and 10-20 minutes of balance, agility and mobility exercises. Study coach is with the participant when they exercise and records exercise and intensity. Study coaches provide behavior modification support through goal setting, encouragement, feedback and reviewing outcomes.

Monitored Exercise and Behavioral Modification Support

Behavioral

The exercise intervention will have a goal of up to minutes (60 minutes 2 x a week) of moderate intensity exercise building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity, 30-60 minutes of functional strength training targeting major muscle groups (to include at a minimum: a squat movement, an upper extremity push movement, an upper extremity pull movement, a carry movement, a stepping movement and a trunk stabilization movement), and 10-20 minutes of balance, agility and mobility exercises. Support for performing their exercise will be provided by a personal trainer at the fitness facility where they exercise for up to seven visits. The remainder of the twice weekly exercise will be completed and logged by the participant on their own. Study coaches provide behavior modification support through goal setting, encouragement, feedback and reviewing outcomes via phone, text and/or email.

Primary outcomes

  1. 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

  2. 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)

  3. Aim 1 Feasibility: Program Fidelity Dosage: Session Duration

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

    mean percentage duration

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  1. Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery

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

    Score is 0-12 with higher as better performance

  2. Aim 2 Exploratory Individual Outcomes: Grip Strength using a hand-held grip dynamometer (lbs. of force)

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

    Measured bilateral in lbs of force, higher is better performance

  3. Aim 2 Exploratory Individual Outcomes: Perception of cognition through the Patient-Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Testing survey

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

    0-100% with lower than 50% below average and higher above average performance

Study contacts

Contact information is provided by the study sponsor or research team.

Amberly Osteen

CONTACT

[email protected]

(803) 216-3896

Elizabeth Regan, PhD

CONTACT

[email protected]

7046092409

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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