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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Supervised Exercise and Behavior Modification Support
BehavioralThe 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
BehavioralThe 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
Trial outcomes
Primary outcomes
Aim 1 Feasibility: Recruitment and Uptake through qualified referrals
percent of qualified referrals beginning the program
Aim 1 Feasibility: Program Fidelity Dosage: session adherence
mean percentage adherence (number of sessions completed / number of sessions scheduled)
Aim 1 Feasibility: Program Fidelity Dosage: Session Duration
mean percentage duration
Aim 1 Feasibility: Program Fidelity: Exercise Intensity
mean percent of time spent in target heart rate zone of 60-85% of age predicted maximum
Secondary outcomes
Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery
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)
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
0-100% with lower than 50% below average and higher above average performance
Sponsors and contacts
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