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Dose Response Study of Aerobic Exercise in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01129115
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Jeff Burns, MD, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE May 18, 2010
First Posted Date  ICMJE May 24, 2010
Results First Submitted Date  ICMJE November 4, 2015
Results First Posted Date  ICMJE February 15, 2016
Last Update Posted Date February 15, 2016
Study Start Date  ICMJE May 2010
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • Visuospatial Processing [ Time Frame: 26 weeks ]
    Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.
  • Change in Maximal Oxygen Consumption [ Time Frame: 26 weeks ]
    Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness
  • Change in Physical Performance Test [ Time Frame: 26 Week ]
    The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2010)
Primary Cognitive Outcome Measure: General Cognition [ Time Frame: baseline, 26 , and 52 ]
We predict that general cognition will be enhanced by the aerobic exercise intervention. Greater cognitive gains will be made by individuals with more fitness gains. Finally, the intervention will affect all cognitive domains but it will affect executive functioning domains relatively more than other domains.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • Verbal Memory [ Time Frame: 26 weeks ]
    Verbal Memory is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Logical Memory, Delayed Logical Memory, Selective Reminding Task - Free Recall Total, Boston Naming Test. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance.Negative numbers indicate worsening performance.
  • Simple Attention [ Time Frame: 26 Weeks ]
    Simple Attention is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Digit span Forward and Backward, Letter Numbers Sequencing. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.
  • Set Maintenance & Shifting [ Time Frame: 26 Weeks ]
    Set Maintenance and Switching is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: DKEFS Card Sort, Animal and Vegetable Category Fluency. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.
  • Reasoning [ Time Frame: 26 Weeks ]
    Reasoning is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests:Letter and Word Inductive Reasoning, Matrix Reasoning. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2010)
Secondary Outcomes will measure memory [ Time Frame: baseline, 26 , and 52 ]
Tests selected consistently yield moderate to large sized exercise-related effects across many studies and possess good ecological validity when aggregated by cognitive domain.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Response Study of Aerobic Exercise in Older Adults
Official Title  ICMJE Dose Response Study of Exercise for Age-related Cognitive Changes
Brief Summary This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. Participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. This is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. Aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Behavioral: Nonexercise control group
    Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
  • Behavioral: Aerobic Exercise Group 1
    The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
  • Behavioral: Aerobic Exercise Group 2
    The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
  • Behavioral: Aerobic Exercise Group 3
    The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Study Arms  ICMJE
  • Active Comparator: Nonexercise control group
    Intervention: Behavioral: Nonexercise control group
  • Experimental: Aerobic Exercise Group 1
    Intervention: Behavioral: Aerobic Exercise Group 1
  • Experimental: Aerobic Exercise Group 2
    Intervention: Behavioral: Aerobic Exercise Group 2
  • Experimental: Aerobic Exercise Group 3
    Intervention: Behavioral: Aerobic Exercise Group 3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2014)
101
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2010)
100
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent
  • Age 65 years or older
  • Underactive or sedentary based on the Telephone Assessment of Physical Activity
  • Community dwelling with a caregiver willing to accompany the participant to visits to the screening evaluation. The caregiver must visit with the subject more than five times a week.
  • Nondemented: Clinical Dementia Rating (CDR) 0
  • Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
  • Stable doses of medications for at least 30 days prior to screening.
  • Likely to participate in all scheduled evaluations and complete the exercise program over 52 weeks

Exclusion Criteria:

  • Dementia
  • CDR > 0
  • Current clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to Diagnostic Statistical Manual (DSM)-IV criteria or Geriatric Depression score of 5 or greater.
  • Significant psychiatric symptoms (e.g., hallucinations) that could impair the completion of the study
  • Current clinically-significant systemic illness likely to result in deterioration of the patient's condition or affect the patient's safety during the study
  • History of clinically-evident stroke
  • Clinically-significant infection within the last 30 days
  • Myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the last two-years.
  • Uncontrolled hypertension within the last 6 months
  • History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
  • History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
  • Insulin-dependent diabetes mellitus
  • Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01129115
Other Study ID Numbers  ICMJE 11883
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeff Burns, MD, University of Kansas Medical Center
Study Sponsor  ICMJE Jeff Burns, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Burns, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP