Combining Exercise and Cognitive Training to Improve Everyday Function

Phase 3

Completed

• Conditions: Effect of Exercise on Cognitive Function
• Interventions: Behavioral: Intensive Exercise; Behavioral: Home Exercise; Behavioral: Health Education; Behavioral: Cognitive Training

• Registration Number: NCT01603784
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-05-02
• Study First Submitted QC: 2012-05-18
• Study First Posted: 2012-05-23
• Primary Completion: 2012-08
• Study Completion: 2013-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Exercise	Intensive Exercise	Aerobic Exercise + Health Education
Cognitive	Home Exercise	Home Exercise + Cognitive Training
Control	Health Education	Home Exercise + Health Education
Exercise	Health Education	Aerobic Exercise + Health Education
Cognitive	Cognitive Training	Home Exercise + Cognitive Training
Combined	Intensive Exercise	Aerobic Exercise + Cognitive Training
Control	Home Exercise	Home Exercise + Health Education
Combined	Cognitive Training	Aerobic Exercise + Cognitive Training

Primary Outcome Measures

Name	Time	Method
Cooking Breakfast task	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	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	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 Outcome Measures

Name	Time	Method
Peak Aerobic Power	Baseline, Month 6	The participant walks on a treadmill, with a progressively increased grade (level of incline)over a 8-15 minute period, with continuous measurements of expired oxygen and carbon dioxide. Information obtained is used to measure the total amount of work that the person performs during the test. The participant has continuous ECG monitoring during the test.
Activities of Daily Living--Yale Physical Activity Scale (YPAS)	Baseline, Month 3, Month 6, Month 12	Questionnaire that objectively measures frequency and time spent per week performing common physical activities, which are used to caculate total weekly metabolic work (KCals).
Uniform Data Set (UDS)	Baseline, Month 12	A standardized interview to ascertain and assess demographic information, health status, cognitive status, medications, and functional status. The interview is conducted with the research participant and a collateral source historian.
Late Life Function & Disability Index (LLFDI)	Baseline, Month 6, Month 12	A standardized questionnaire to assess performance of activities of daily living (ADLs) and the level of difficulty experienced while performing each activity.
Geriatric Depression Scale	Baseline, Month 12	A 15-item questionnaire to assess for symptoms of depression.
Pittsburgh Sleep Quality Index (PSQI)	Baseline, Month 6, Month 12	Questionnaire to assess sleep quality and events in the prior month. Includes a section for roommate/bed partner response.
Objective Physical Performance Tests	Baseline, Month 6	Physical Performance Test, Senior Fit Test, Dual Task Walking Speed. These tests objectively measure walking speed, muscle strength, balance, and coordination.
Prospective and Retrospective Memory Questionnaire (PMRQ)	Baseline, Month 6, Month 12	Objective questionnaires to measure ability to learn and recall information.
Cognitive assessment battery	Baseline, Month 6, Month 12	Array of cognitive tasks to assess performance in a variety of areas. Includes Stroop (response time and attentional control), Trials A/B (sequencing), Crossing Off (motor control), Logical Memory (story recall), and Digit Symbol (corresponding symbols to digits).

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States