Dose Response Study of Aerobic Exercise in Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeff Burns, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01129115
First received: May 18, 2010
Last updated: January 14, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease
Behavioral: Nonexercise control group
Behavioral: Aerobic Exercise Group 1
Behavioral: Aerobic Exercise Group 2
Behavioral: Aerobic Exercise Group 3
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Response Study of Exercise for Age-related Cognitive Changes

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Visuospatial Processing [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Verbal Memory [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 101
Study Start Date: May 2010
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nonexercise control group 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.
Experimental: Aerobic Exercise Group 1 Behavioral: Aerobic Exercise Group 1
The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Experimental: Aerobic Exercise Group 2 Behavioral: Aerobic Exercise Group 2
The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Experimental: Aerobic Exercise Group 3 Behavioral: Aerobic Exercise Group 3
The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129115

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Jeff Burns, MD
Investigators
Principal Investigator: Jeffrey Burns, MD University of Kansas Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Burns, MD, Assistant Professor, Director of the Alzheimer & Memory Center & AD Clinical Research Program, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01129115     History of Changes
Other Study ID Numbers: 11883 
Study First Received: May 18, 2010
Results First Received: November 4, 2015
Last Updated: January 14, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2016