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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG034581-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| St. Louis Jewish Community Center | UNKNOWN |
| St. Louis Naturally Occurring Retirement Community (NORC) | UNKNOWN |
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The purpose of this randomized, controlled, prospective study is to evaluate the benefits of combining aerobic exercise with cognitive training for optimizing cognitive function. The study will enroll 109 men and women, age 55-75 years who are in stable health and without contraindications to exercise or evidence of dementia or cognitive impairment. Individuals will be randomly assigned to one of four groups for six months: Aerobic Exercise and Health Education, Home Exercise and Cognitive Training, Aerobic Exercise and Cognitive Training, and Home Exercise and Health Education. Participants will undergo measurements of cognitive function, physical performance, and complete questionaires about daily activities, physical activity, and quality of life at baseline (pre-intervention), and at 6 and 12 months after baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined | Experimental | Aerobic Exercise + Cognitive Training |
|
| Exercise | Experimental | Aerobic Exercise + Health Education |
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| Cognitive | Experimental | Home Exercise + Cognitive Training |
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| Control | Experimental | Home Exercise + Health Education |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Exercise | Behavioral | Standardized aerobic training program that is individualized to each participant's fitness level, and supervised by a certified exercise specialist. Participants attend 3 training sessions per week for 6 months. The session begins with a 10-15 minute warm-up. Participants then exercise on a treadmill or stationary bike, followed by "cool-down" activities. Heart rate and rating of perceived exertion are used to evaluate exercise intensity. Participants begin at ~30 min/day 60-70% of HR max and/or an equivalent level of RPE, and progress to 45-50 minutes at 75-85% for HR max. |
| Measure | Description | Time Frame |
|---|---|---|
| Memory for Medical Information | This task measures the ability of the individual to learn and recall complex medical information, and the source of the information. | Change in memory task performance between baseline and 6 months |
| Cooking Breakfast task | Participants engage in a computerized laboratory simulation of a cooking task to assesses cognitive dimensions of planning, prospective memory, monitoring the progress of ongoing activity, anticipating potential problems, task switching, and task coordination. | Change in task performance between baseline and 6 months |
| Virtual Week task | Participants engage a computerized board game that simulates choices about, and recall of, daily and weekly activities. | Change in task performance between baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Activities of Daily Living--Yale Physical Activity Scale (YPAS) | Questionnaire that objectively measures frequency and time spent per week performing common physical activities, which are used to caculate total weekly metabolic work (KCals). | Baseline, Month 3, Month 6, Month 12 |
| Uniform Data Set (UDS) |
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Inclusion Criteria:
Exclusion Criteria:
participation in a regular exercise program in last 6 months
participation in a cognitive training program in last 6 months
inability to walk on a treadmill or ride an exercise bike
less than a 10th grade education
mild cognitive impairment or dementia
cigarette smoking within the previous year
history of alcohol or substance abuse
BMI greater than 35
insulin-dependent diabetes
major and/or unstable medical, neurological, or psychiatric disorder, including:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Binder, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Home Exercise | Behavioral | Exercise program consisting of stretching, range of motion, and simple yoga exercises designed to improve flexibility. Each participant has a 60-minute sessions with an exercise trainer to teach them how to perform the exercises correctly. They are also given diagrams illustrating the exercises, along with written instructions. They are instructed to perform these exercises at home at least 3 times per week for 30 - 45 minutes. They also go to the recreational center monthly to meet with an exercise trainer to ensure that they are doing the exercises correctly. Participants record their exercise activities on a calendar for the 6 months. |
|
| Cognitive Training | Behavioral | Computer-based training that is is administered 3 days per week for 8 weeks during months 5 and 6. The training program focuses on 3 types of cognitive processes: task coordination, prospective memory, and retrospective memory retrieval. One day of the week is devoted to each of the three cognitive processes. Some training sessions include a homework assignment for application and practice of the target cognitive processes in everyday activities. |
|
| Health Education | Behavioral | Weekly educational sessions are administered during months 5 and 6, conducted at the recreational center by research staff. Sessions last 1 hour, and cover health and other topics unrelated to exercise or cognition, such as nutrition, hearing loss, stroke, and saving energy in one's home. At the completion of each session, participants are given a "homework" assignment. |
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A standardized interview to ascertain and assess demographic information, health status, cognitive status, medications, and functional status. The interview is conducted with the research participant and a collateral source historian. |
| Baseline, Month 12 |
| Geriatric Depression Scale | A 15-item questionnaire to assess for symptoms of depression. | Baseline, Month 12 |
| Late Life Function & Disability Index (LLFDI) | A standardized questionnaire to assess performance of activities of daily living (ADLs) and the level of difficulty experienced while performing each activity. | Baseline, Month 6, Month 12 |
| Pittsburgh Sleep Quality Index (PSQI) | Questionnaire to assess sleep quality and events in the prior month. Includes a section for roommate/bed partner response. | Baseline, Month 6, Month 12 |
| Objective Physical Performance Tests | Physical Performance Test, Senior Fit Test, Dual Task Walking Speed. These tests objectively measure walking speed, muscle strength, balance, and coordination. | Baseline, Month 6 |
| Prospective and Retrospective Memory Questionnaire (PMRQ) | Objective questionnaires to measure ability to learn and recall information. | Baseline, Month 6, Month 12 |
| Peak Aerobic Power | The participant walks on a treadmill, with a progressively increased grade (level of incline)over a 8-15 minute period, with continuous measurements of expired oxygen and carbon dioxide. Information obtained is used to measure the total amount of work that the person performs during the test. The participant has continuous ECG monitoring during the test. | Baseline, Month 6 |
| Cognitive assessment battery | Array of cognitive tasks to assess performance in a variety of areas. Includes Stroop (response time and attentional control), Trials A/B (sequencing), Crossing Off (motor control), Logical Memory (story recall), and Digit Symbol (corresponding symbols to digits). | Baseline, Month 6, Month 12 |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |