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NCT06799429NARecruiting

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

University of South Carolina

Start Date

3/13/2026

Completion Date

11/17/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

BEHAVIORAL

Supervised Exercise and Behavior Modification Support

BEHAVIORAL

Monitored Exercise and Behavioral Modification Support

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Conditions

Mild-moderate Cognitive Impairment

Locations

Arnold School of Public Health

Columbia, South Carolina 29208

United States

Sumter YMCA

Sumter, South Carolina 29150

United States