Recruiting

Brain Health Fitness

Sponsor:

University of South Carolina

Code:

NCT06799429

Conditions

Mild-moderate Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Supervised Exercise and Behavior Modification Support

Monitored Exercise and Behavioral Modification Support

Study Details

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.

Conditions

Mild-moderate Cognitive Impairment

Study ID

NCT06799429

Start date

Mar 13, 2026

Status verified date

Apr, 2026

Completion date

Nov 17, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Aim 1 Feasibility: Recruitment and Uptake through qualified referrals [ Time Frame: through study completion, an average of 1 year ]
  • Aim 1 Feasibility: Program Fidelity Dosage: session adherence [ Time Frame: through study completion, an average of 1 year ]
  • Aim 1 Feasibility: Program Fidelity Dosage: Session Duration [ Time Frame: through study completion, an average of 1 year ]
  • Aim 1 Feasibility: Program Fidelity: Exercise Intensity [ Time Frame: through study completion, an average of 1 year ]
  • Aim 1 Feasibility: Acceptability: Participant Satisfaction [ Time Frame: 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) [ Time Frame: pre-program (baseline), 3, 6 9 and 12 months ]
  • Aim 2 Exploratory Individual Outcomes: Cardiovascular Endurance through the six-minute walk test [ Time Frame: pre-program (baseline), 3, 6 9 and 12 months ]
  • 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 ]

Central Contacts and Locations

Central contacts

Elizabeth Regan, PhD

7046092409eregan@mailbox.sc.edu

Amberly Osteen

(803) 216-3896Amberly.osteen@uscmed.sc.edu

Locations

Arnold School of Public Health

Recruiting

Columbia, South Carolina, United States, 29208

Contacts

Elizabeth Regan

7046092409eregan@mailbox.sc.edu

Sumter YMCA

Recruiting

Sumter, South Carolina, United States, 29150

Contacts

Elizabeth Regan, DPT, PhD

704-609-2409eregan@mailbox.sc.edu

More Information

Sponsor

University of South Carolina

Last update posted

Jun 1, 2026

Last verified

Apr, 2026

Keywords

  • cognitive impairment
  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-06-01.