Overview

This trial is active, not recruiting.

Condition effect of exercise on cognitive function
Treatments intensive exercise, home exercise, cognitive training, health education
Phase phase 3
Sponsor Washington University School of Medicine
Collaborator St. Louis Jewish Community Center
Start date March 2010
End date October 2012
Trial size 109 participants
Trial identifier NCT01603784, 1R01AG034581-01, 201102416

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Aerobic Exercise + Cognitive Training
intensive exercise
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.
cognitive training
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.
(Experimental)
Aerobic Exercise + Health Education
intensive exercise
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.
health education
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.
(Experimental)
Home Exercise + Cognitive Training
home exercise
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
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.
(Experimental)
Home Exercise + Health Education
home exercise
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.
health education
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.

Primary Outcomes

Measure
Memory for Medical Information
time frame: Change in memory task performance between baseline and 6 months
Cooking Breakfast task
time frame: Change in task performance between baseline and 6 months
Virtual Week task
time frame: Change in task performance between baseline and 6 months

Secondary Outcomes

Measure
Activities of Daily Living--Yale Physical Activity Scale (YPAS)
time frame: Baseline, Month 3, Month 6, Month 12
Uniform Data Set (UDS)
time frame: Baseline, Month 12
Geriatric Depression Scale
time frame: Baseline, Month 12
Late Life Function & Disability Index (LLFDI)
time frame: Baseline, Month 6, Month 12
Pittsburgh Sleep Quality Index (PSQI)
time frame: Baseline, Month 6, Month 12
Objective Physical Performance Tests
time frame: Baseline, Month 6
Prospective and Retrospective Memory Questionnaire (PMRQ)
time frame: Baseline, Month 6, Month 12
Peak Aerobic Power
time frame: Baseline, Month 6
Cognitive assessment battery
time frame: Baseline, Month 6, Month 12

Eligibility Criteria

Male or female participants from 55 years up to 75 years old.

Inclusion Criteria: - age 55-75 years (inclusive) - English-speaking - sufficient visual and auditory perception to complete testing - available informant (someone who knows the individual well) - Clinical Dementia Rating of 0 (non-demented per the screening assessment). 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: - active congestive heart failure - unstable angina - effort angina - nocturnal angina - MI within previous 6 months - ECG evidence of serious arrhythmias and/or acute myocardial ischemia reflected by ST-segment depression of 0.3 mm - resting blood pressure above 170 systolic or 100 diastolic - chronic infections - advanced arthritis - contractures or weakness due to CVA that would prevent adequate performance of the exercises. - disabling stroke - late stage renal or liver disease - major affective disorder with active symptoms

Additional Information

Official title Combining Exercise and Cognitive Training to Improve Everyday Function
Principal investigator Ellen Binder, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.