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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult (age >18)

medical diagnosis of mild-moderate cognitive impairment

medical clearance by referring provider for exercise

able to follow 2-step commands

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Supervised Exercise and Behavior Modification Support

    Behavioral

    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

    Behavioral

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: In-Person GroupExperimental treatment 1 intervention
Group B: Distance GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Aim 1 Feasibility: Recruitment and Uptake through qualified referrals

percent of qualified referrals beginning the program

Time frame
through study completion, an average of 1 year
2

Aim 1 Feasibility: Program Fidelity Dosage: session adherence

mean percentage adherence (number of sessions completed / number of sessions scheduled)

Time frame
through study completion, an average of 1 year
3

Aim 1 Feasibility: Program Fidelity Dosage: Session Duration

mean percentage duration

Time frame
through study completion, an average of 1 year
4

Aim 1 Feasibility: Program Fidelity: Exercise Intensity

mean percent of time spent in target heart rate zone of 60-85% of age predicted maximum

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery

Score is 0-12 with higher as better performance

Time frame
pre-program (baseline), 3, 6 9 and 12 months
2

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

Time frame
pre-program (baseline), 3, 6 9 and 12 months
3

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

Time frame
pre-program (baseline), 3, 6 9 and 12 months

Other outcomes

Sponsors and contacts

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