Clinical trial NCT01603784: Combining Exercise and Cognitive Training to Improve Everyday Function
Official title: Combining Exercise and Cognitive Training to Improve Everyday Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Effect of Exercise on Cognitive Function
Keywords: exercise
cognition
memory
adult
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: St. Louis Jewish Community Center
name: St. Louis Naturally Occurring Retirement Community (NORC)
First posted: 2012-05-23
Enrollment: 96
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Memory for Medical Information
timeFrame: Change in memory task performance between baseline and 6 months
measure: Cooking Breakfast task
timeFrame: Change in task performance between baseline and 6 months
measure: Virtual Week task
timeFrame: Change in task performance between baseline and 6 months
Secondary outcomes:
measure: Activities of Daily Living--Yale Physical Activity Scale (YPAS)
timeFrame: Baseline, Month 3, Month 6, Month 12
measure: Uniform Data Set (UDS)
timeFrame: Baseline, Month 12
measure: Geriatric Depression Scale
timeFrame: Baseline, Month 12
measure: Late Life Function & Disability Index (LLFDI)
timeFrame: Baseline, Month 6, Month 12
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, Month 6, Month 12
measure: Objective Physical Performance Tests
timeFrame: Baseline, Month 6
measure: Prospective and Retrospective Memory Questionnaire (PMRQ)
timeFrame: Baseline, Month 6, Month 12
measure: Peak Aerobic Power
timeFrame: Baseline, Month 6
measure: Cognitive assessment battery
timeFrame: Baseline, Month 6, Month 12
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ellen Binder, MD
role: PRINCIPAL_INVESTIGATOR
References: