Train Your Brain Fitness SC: An Exercise Intervention for People With Cognitive Impairments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Aim 1 Feasibility: Recruitment and Uptake through qualified referrals
研究概览
简要总结
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:
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (age >18)
- •medical diagnosis of mild-moderate cognitive impairment
- •medical clearance by referring provider for exercise
- •able to follow 2-step commands
排除标准
- •significant pain with movement (>5/10)
- •severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgment at Intake)
研究组 & 干预措施
In-Person Group
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.
干预措施: Supervised Exercise and Behavior Modification Support (Behavioral)
Distance Group
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.
干预措施: Monitored Exercise and Behavioral Modification Support (Behavioral)
结局指标
主要结局
Aim 1 Feasibility: Recruitment and Uptake through qualified referrals
时间窗: through study completion, an average of 1 year
percent of qualified referrals beginning the program
Aim 1 Feasibility: Program Fidelity Dosage: session adherence
时间窗: 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
时间窗: through study completion, an average of 1 year
mean percentage duration
Aim 1 Feasibility: Program Fidelity: Exercise Intensity
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: pre-program (baseline), 3, 6 9 and 12 months
Score is number of correct responses (0-45), with higher score as better performance
次要结局
- Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery(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)(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(pre-program (baseline), 3, 6 9 and 12 months)
研究者
Elizabeth Regan
Clinical Associate Professor
University of South Carolina