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

Overview

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.

Interventions

• 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 10-2
• 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 10-2

Primary outcome measures

• 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]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Arnold School of Public Health — Columbia
• Sumter YMCA — Sumter

Identifiers

NCT: NCT06799429 · Pro00139826

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗