NCT06799429

Train Your Brain SC: Exercise for People With Mild-moderate Cognitive Impairments

Implementing Train Your Brain SC: An On-going Individual Coaching and Exercise Intervention for People Living With Mild-moderate Cognitive Impairments in South Carolina

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test a 12-month, 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. 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). Participants will exercise twice a week in-person with a coach or at a distance location with coaching support for up to 12 months.

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 times per week for six months. Coaches will provide exercise plans, and monitor and provide feedback as participants exercise. Participants will wear a heart rate monitor to record exertion. Participants will be able to continuously attend as long as they are attending regularly. 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. Participants will exercise on their own 2 x a week for 6 months. 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 personal trainer support for 7 visits in the first 12-weeks. Participants will be responsible for completing the remaining workouts on their own. Participants will log their exercises either in the coaching software or in paper formats, have weekly check-ins with fitness center coaches and have options to message the fitness center coaches with questions. Participants who do not log any activity and miss weekly check-ins will have follow up from fitness center coaches.

Conditions

• Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Supervised in-person group	Individually prescribed and directed/supervised by a fitness trainer in-person, multi-mode exercise 2 x a week for 30-60 minutes The fitness trainer is with the participant while they exercise.
BEHAVIORAL	Monitored distance group	Individually prescribed ulti-mode exercise 2 x a week for 30-60 minutes. Written plan/feedback and support by phone/text or email is provided by a research team fitness trainer who is not present with the participant when they exercise. Support for performing their exercise will be provided by a fitness trainer at the fitness facility where they exercise for up to seven visits.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-29
• Last updated: 2026-02-24

Locations

2 sites across 1 country: United States