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Clinical Trials/NCT01603784
NCT01603784
Completed
Phase 3

Combining Exercise and Cognitive Training to Improve Everyday Function

Washington University School of Medicine1 site in 1 country96 target enrollmentMarch 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Effect of Exercise on Cognitive Function
Sponsor
Washington University School of Medicine
Enrollment
96
Locations
1
Primary Endpoint
Cooking Breakfast task
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
June 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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:

Outcomes

Primary Outcomes

Cooking Breakfast task

Time Frame: Change in task performance between baseline and 6 months

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.

Memory for Medical Information

Time Frame: Change in memory task performance between baseline and 6 months

This task measures the ability of the individual to learn and recall complex medical information, and the source of the information.

Virtual Week task

Time Frame: Change in task performance between baseline and 6 months

Participants engage a computerized board game that simulates choices about, and recall of, daily and weekly activities.

Secondary Outcomes

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

Study Sites (1)

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