Mild-moderate Cognitive ImpairmentNCT06799429
Train Your Brain Fitness SC: An Exercise Intervention for People With Cognitive Impairments
A study testing Supervised Exercise and Behavior Modification Support and Monitored Exercise and Behavioral Modification Support in people with Mild-moderate Cognitive Impairment, run by University of South Carolina at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild-moderate Cognitive Impairment
- What is being tested?
- Supervised Exercise and Behavior Modification Support and Monitored Exercise and Behavioral Modification Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2026to 17 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (age >18)
- medical diagnosis of mild-moderate cognitive impairment
- medical clearance by referring provider for exercise
- able to follow 2-step commands
Who cannot join
- significant pain with movement (>5/10)
- severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgment at Intake)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Arnold School of Public Health
Columbia, South Carolina, 29208
Elizabeth Regan, 7046092409, eregan@mailbox.sc.edu
- Recruiting
Sumter YMCA
Sumter, South Carolina, 29150
Elizabeth Regan, DPT, PhD, 704-609-2409, eregan@mailbox.sc.edu
About this study
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:
- 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.
- 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.
Read the 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.
- Conditions
- Mild-moderate Cognitive Impairment
- Being tested
- Supervised Exercise and Behavior Modification Support, Monitored Exercise and Behavioral Modification Support
- Keywords
- cognitive impairment, exercise
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise and Behavior Modification SupportBehavioural
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 SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Supervised Exercise and Behavior Modification Support |
| 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. Receives: Behavioral: Monitored Exercise and Behavioral Modification Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1 Feasibility: Recruitment and Uptake through qualified referrals
percent of qualified referrals beginning the program
Measured: 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)
Measured: through study completion, an average of 1 year
Aim 1 Feasibility: Program Fidelity Dosage: Session Duration
mean percentage duration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: pre-program (baseline), 3, 6 9 and 12 months
Secondary outcomes (3)
Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery
Score is 0-12 with higher as better performance
Measured: 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
Measured: 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
Measured: pre-program (baseline), 3, 6 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start13 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion17 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild-moderate Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Regan, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799429
- Sponsor's protocol ID
- Pro00139826
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Train Your Brain Fitness SC: An Exercise Intervention for People With Cognitive Impairments
- ClinicalTrials.gov ID
- NCT06799429
- Acronym / sponsor ID
- Pro00139826
- Conditions
- Mild-moderate Cognitive Impairment
- Keywords
- cognitive impairment, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Group | Experimental | Behavioral: Supervised Exercise and Behavior Modification SupportFor 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. |
| Distance Group | Experimental | Behavioral: Monitored Exercise and Behavioral Modification SupportFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult (age >18)
- medical diagnosis of mild-moderate cognitive impairment
- medical clearance by referring provider for exercise
- able to follow 2-step commands
Key exclusion criteria (2 listed)
- significant pain with movement (>5/10)
- severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgment at Intake)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Exercise and Behavior Modification SupportThe 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. | Behavioural | In-Person Group |
| Monitored Exercise and Behavioral Modification SupportThe 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. | Behavioural | Distance Group |
Primary outcome
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: 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 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 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
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise and Behavior Modification Support and Monitored Exercise and Behavioral Modification Support in people with Mild-moderate Cognitive Impairment, run by University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Regan, PhD (7046092409, eregan@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1 Feasibility: Recruitment and Uptake through qualified referrals (time frame: through study completion, an average of 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.