Mild-moderate Cognitive Impairment
Conditions
Keywords
cognitive impairment, exercise
Brief summary
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.
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 two times per week. Study coaches will provide exercise plans, and monitor and provide feedback as participants exercise. Participants will wear a heart rate monitor to record exertion and coaches will record exercise and intensity in online coaching software. 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. 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 facility personal trainer support for 7 visits in the first 12-weeks and complete the remaining twice weekly exercise on their own. Participants will log their exercises and intensity either in the coaching software or in paper formats, have bi-weekly check-ins with fitness center coaches and have options to message the fitness center coaches with questions.
Interventions
BEHAVIORALSupervised Exercise and Behavior Modification Support
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.
BEHAVIORALMonitored Exercise and Behavioral Modification Support
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.
Sponsors
University of South Carolina
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult (age \>18) * medical diagnosis of mild-moderate cognitive impairment * medical clearance by referring provider for exercise * able to follow 2-step commands
Exclusion criteria
* significant pain with movement (\>5/10) * severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgment at Intake)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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), 3, 6 9 and 12 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), 3, 6 9 and 12 months | Score is meters walked, higher is better performance |
| Aim 2 Exploratory Individual Outcomes: Working Memory through the Auditory Verbal Learning Test (NIH Toolbox) | pre-program (baseline), 3, 6 9 and 12 months | Score is number of correct responses (0-45), with higher score as better performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery | pre-program (baseline), 3, 6 9 and 12 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), 3, 6 9 and 12 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), 3, 6 9 and 12 months | 0-100% with lower than 50% below average and higher above average performance |
Countries
United States
Contacts
CONTACTElizabeth Regan, PhD
CONTACTAmberly Osteen
Outcome results
None listed