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.

Study Overview

• Status: Recruiting
• Conditions: Mild-moderate Cognitive Impairment
• Intervention / Treatment: Behavioral: Supervised Exercise and Behavior Modification Support; Behavioral: Monitored Exercise and Behavioral Modification Support

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Regan, PhD; Phone Number: 7046092409; Email: eregan@mailbox.sc.edu
• Study Contact Backup: Name: Amberly Osteen; Phone Number: (803) 216-3896; Email: Amberly.osteen@uscmed.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • Arnold School of Public Health
      • Contact: Elizabeth Regan; Phone Number: 7046092409; Email: eregan@mailbox.sc.edu
    • Sumter, South Carolina, United States, 29150
      • Recruiting
      • Sumter YMCA
      • Contact: Elizabeth Regan, DPT, PhD; Phone Number: 704-609-2409; Email: eregan@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-Person Group; 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.	Behavioral: Supervised Exercise and Behavior Modification Support; 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.
Experimental: Distance Group; 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.	Behavioral: Monitored Exercise and Behavioral Modification Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 1 Feasibility: Recruitment and Uptake through qualified referrals	percent of qualified referrals beginning the program	through study completion, an average of 1 year
Aim 1 Feasibility: Program Fidelity Dosage: session adherence	mean percentage adherence (number of sessions completed / number of sessions scheduled)	through study completion, an average of 1 year
Aim 1 Feasibility: Program Fidelity Dosage: Session Duration	mean percentage duration	through study completion, an average of 1 year
Aim 1 Feasibility: Program Fidelity: Exercise Intensity	mean percent of time spent in target heart rate zone of 60-85% of age predicted maximum	through study completion, an average of 1 year
Aim 1 Feasibility: Acceptability: Participant Satisfaction	mean of 5 point likert scale 1-not satisfied to 5-extremely satisfied	through study completion, an average of 1 year
Aim 2 Exploratory Individual Outcomes: Processing Speed and Executive Function through the Oral Symbol Digits Test (NIH Toolbox)	Score is number of correct responses (0-144), with higher score as better performance	pre-program (baseline), 3, 6 9 and 12 months
Aim 2 Exploratory Individual Outcomes: Cardiovascular Endurance through the six-minute walk test	Score is meters walked, higher is better performance	pre-program (baseline), 3, 6 9 and 12 months
Aim 2 Exploratory Individual Outcomes: Working Memory through the Auditory Verbal Learning Test (NIH Toolbox)	Score is number of correct responses (0-45), with higher score as better performance	pre-program (baseline), 3, 6 9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery	Score is 0-12 with higher as better performance	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)	Measured bilateral in lbs of force, higher is better performance	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	0-100% with lower than 50% below average and higher above average performance	pre-program (baseline), 3, 6 9 and 12 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Foundation of Physical Therapy Research

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 17, 2026

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: exercise; cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Behavior; Cognitive Dysfunction; Motor Activity
• Other Study ID Numbers: Pro00139826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Demographic, clinical data, outcomes data (survey and functional measures) and exercise intervention session data (mode, intensity, duration) will be generated for all participants. Demographic and clinical data will be collected at the start of the intervention. Outcomes data will be collected at the beginning of the program, at mid-point (3 months) and at the end of the program (6 months). All data will be de-identified prior to receipt by the data archive repository, but information to tie each participant to a unique identifier for the data archive will be maintained for each participant.

In addition, global program feasibility data (recruitment and uptake, fidelity, intensity, acceptability) will be generated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No