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

Conditions

• Mild-moderate Cognitive Impairment

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Mar 13, 2026

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Nov 17, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

Aim 1 Feasibility: Recruitment and Uptake through qualified referrals [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

• Elizabeth Regan, PhD
  7046092409
  [email protected]
• Amberly Osteen
  (803) 216-3896
  [email protected]

Locations (2)

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