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

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.

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.

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.