Brain Health Fitness Program: Exercise for People with Mild-moderate Cognitive Impairments

Not Applicable

Recruiting

• Conditions: Cognitive Impairment

• Registration Number: NCT06799429
• Lead Sponsor: University of South Carolina

Brief Summary

The goal of this clinical trial is to test a 6-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-months and 6-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 six months.

Detailed Description

In person Exercise Group:

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:

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 or at home and it will be shared through a coaching software. 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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• medical diagnosis of mild-moderate cognitive impairment
• medically cleared for exercise
• able to follow 2-step commands Exclusion criteria are significant pain with movement (>5/10)

Exclusion Criteria

• significant pain with movement (>5/10)
• severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgement).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Aim 1 Feasibility: Recruitment and Uptake through qualified referrals	through study completion, an average of 1 year	percent of qualified referrals beginning the program
Aim 1 Feasibility: Program Fidelity Dosage: session adherence	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	through study completion, an average of 1 year	mean percentage duration
Aim 1 Feasibility: Program Fidelity: Exercise Intensity	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	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)	pre-program (baseline), mid-program (3 months) and post-program (6-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	pre-program (baseline), mid-program (3 months) and post-program (6-months)	Score is meters walked, higher is better performance

Secondary Outcome Measures

Name	Time	Method
Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery	pre-program (baseline), mid-program (3 months) and post-program (6-months)	Score is 0-12 with higher as better performance
Aim 2 Exploratory Individual Outcomes: Grip Strength using a hand-held grip dynamometer (lbs. of force)	pre-program (baseline), mid-program (3 months) and post-program (6-months)	Measured bilateral in lbs of force, higher is better performance
Aim 2 Exploratory Individual Outcomes: Perception of cognition through the Patient-Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Testing survey	pre-program (baseline), mid-program (3 months) and post-program (6-months)	0-100% with lower than 50% below average and higher above average performance

Trial Locations

Locations (1)

Arnold School of Public Health; 🇺🇸 Columbia, South Carolina, United States