A Phase 3 interventional study of Intensive Exercise and Home Exercise in Effect of Exercise on Cognitive Function, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-03.
Sponsored by Washington University School of Medicine · Phase 3, Interventional, and Prevention
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.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
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Exclusion Criteria:
major and/or unstable medical, neurological, or psychiatric disorder, including:
Aerobic Exercise + Cognitive Training
Behavioral: Intensive Exercise · Behavioral: Cognitive Training
Aerobic Exercise + Health Education
Behavioral: Intensive Exercise · Behavioral: Health Education
Home Exercise + Cognitive Training
Behavioral: Home Exercise · Behavioral: Cognitive Training
Home Exercise + Health Education
Behavioral: Home Exercise · Behavioral: Health Education
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Change in task performance between baseline and 6 months
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).
Time frame: Baseline, Month 3, Month 6, Month 12
Uniform Data Set (UDS)
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.
Time frame: Baseline, Month 12
Geriatric Depression Scale
A 15-item questionnaire to assess for symptoms of depression.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 6
Prospective and Retrospective Memory Questionnaire (PMRQ)
Objective questionnaires to measure ability to learn and recall information.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, Month 6, Month 12
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine