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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-Person Group | Experimental | 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. |
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| Distance Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1 Feasibility: Recruitment and Uptake through qualified referrals | percent of qualified referrals beginning the program | through study completion, an average of 1 year |
| Aim 1 Feasibility: Program Fidelity Dosage: session adherence | mean percentage adherence (number of sessions completed / number of sessions scheduled) | through study completion, an average of 1 year |
| Aim 1 Feasibility: Program Fidelity Dosage: Session Duration | mean percentage duration | through study completion, an average of 1 year |
| Aim 1 Feasibility: Program Fidelity: Exercise Intensity | mean percent of time spent in target heart rate zone of 60-85% of age predicted maximum | through study completion, an average of 1 year |
| Aim 1 Feasibility: Acceptability: Participant Satisfaction | mean of 5 point likert scale 1-not satisfied to 5-extremely satisfied | through study completion, an average of 1 year |
| Aim 2 Exploratory Individual Outcomes: Processing Speed and Executive Function through the Oral Symbol Digits Test (NIH Toolbox) | Score is number of correct responses (0-144), with higher score as better performance | pre-program (baseline), 3, 6 9 and 12 months |
| Aim 2 Exploratory Individual Outcomes: Cardiovascular Endurance through the six-minute walk test |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery | Score is 0-12 with higher as better performance | pre-program (baseline), 3, 6 9 and 12 months |
| Aim 2 Exploratory Individual Outcomes: Grip Strength using a hand-held grip dynamometer (lbs. of force) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Regan, PhD | Contact | 7046092409 | eregan@mailbox.sc.edu | |
| Amberly Osteen | Contact | (803) 216-3896 | Amberly.osteen@uscmed.sc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arnold School of Public Health | Recruiting | Columbia | South Carolina | 29208 | United States |
Demographic, clinical data, outcomes data (survey and functional measures) and exercise intervention session data (mode, intensity, duration) will be generated for all participants. Demographic and clinical data will be collected at the start of the intervention. Outcomes data will be collected at the beginning of the program, at mid-point (3 months) and at the end of the program (6 months). All data will be de-identified prior to receipt by the data archive repository, but information to tie each participant to a unique identifier for the data archive will be maintained for each participant.
In addition, global program feasibility data (recruitment and uptake, fidelity, intensity, acceptability) will be generated.
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| 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. |
|
Score is meters walked, higher is better performance
| pre-program (baseline), 3, 6 9 and 12 months |
| Aim 2 Exploratory Individual Outcomes: Working Memory through the Auditory Verbal Learning Test (NIH Toolbox) | Score is number of correct responses (0-45), with higher score as better performance | pre-program (baseline), 3, 6 9 and 12 months |
Measured bilateral in lbs of force, higher is better performance |
| pre-program (baseline), 3, 6 9 and 12 months |
| 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 | pre-program (baseline), 3, 6 9 and 12 months |
| Sumter YMCA | Recruiting | Sumter | South Carolina | 29150 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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