Combining Exercise and Cognitive Training to Improve Everyday Function

NCT ID: NCT01603784

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-06-30

Brief 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.

Conditions

Effect of Exercise on Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Combined

Aerobic Exercise + Cognitive Training

Group Type: EXPERIMENTAL

Intensive Exercise

Intervention Type: 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.

Cognitive Training

Intervention Type: 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.

Exercise

Aerobic Exercise + Health Education

Group Type: EXPERIMENTAL

Intensive Exercise

Intervention Type: 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.

Health Education

Intervention Type: 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.

Cognitive

Home Exercise + Cognitive Training

Group Type: EXPERIMENTAL

Home Exercise

Intervention Type: 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

Intervention Type: 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.

Control

Home Exercise + Health Education

Group Type: EXPERIMENTAL

Home Exercise

Intervention Type: 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.

Health Education

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis Jewish Community Center

UNKNOWN

Sponsor Role: collaborator

St. Louis Naturally Occurring Retirement Community (NORC)

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Binder, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

1R01AG034581-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201102416

Identifier Type: -

Identifier Source: org_study_id