Combining Exercise and Cognitive Training to Improve Everyday Function
EXACT
2 other identifiers
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 3, 2014
August 1, 2014
2.4 years
May 2, 2012
August 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (9)
Activities of Daily Living--Yale Physical Activity Scale (YPAS)
Baseline, Month 3, Month 6, Month 12
Uniform Data Set (UDS)
Baseline, Month 12
Geriatric Depression Scale
Baseline, Month 12
Late Life Function & Disability Index (LLFDI)
Baseline, Month 6, Month 12
Pittsburgh Sleep Quality Index (PSQI)
Baseline, Month 6, Month 12
- +4 more secondary outcomes
Study Arms (4)
Combined
EXPERIMENTALAerobic Exercise + Cognitive Training
Exercise
EXPERIMENTALAerobic Exercise + Health Education
Cognitive
EXPERIMENTALHome Exercise + Cognitive Training
Control
EXPERIMENTALHome Exercise + Health Education
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63108, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen Binder, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 23, 2012
Study Start
March 1, 2010
Primary Completion
August 1, 2012
Study Completion
June 1, 2013
Last Updated
September 3, 2014
Record last verified: 2014-08