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Dose Response Study of Aerobic Exercise in Older Adults

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nonexercise control group
Aerobic Exercise Group 1
Aerobic Exercise Group 2
Aerobic Exercise Group 3
Sponsored by
Jeff Burns, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Nonexercise control group

Aerobic Exercise Group 1

Aerobic Exercise Group 2

Aerobic Exercise Group 3

Arm Description

Outcomes

Primary Outcome Measures

Visuospatial Processing
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
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
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
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
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
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
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.

Full Information

First Posted
May 18, 2010
Last Updated
January 14, 2016
Sponsor
Jeff Burns, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01129115
Brief Title
Dose Response Study of Aerobic Exercise in Older Adults
Official Title
Dose Response Study of Exercise for Age-related Cognitive Changes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeff Burns, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nonexercise control group
Arm Type
Active Comparator
Arm Title
Aerobic Exercise Group 1
Arm Type
Experimental
Arm Title
Aerobic Exercise Group 2
Arm Type
Experimental
Arm Title
Aerobic Exercise Group 3
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Nonexercise control group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Group 1
Intervention Description
The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Group 2
Intervention Description
The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Group 3
Intervention Description
The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Primary Outcome Measure Information:
Title
Visuospatial Processing
Description
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.
Time Frame
26 weeks
Title
Change in Maximal Oxygen Consumption
Description
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
Time Frame
26 weeks
Title
Change in Physical Performance Test
Description
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.
Time Frame
26 Week
Secondary Outcome Measure Information:
Title
Verbal Memory
Description
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.
Time Frame
26 weeks
Title
Simple Attention
Description
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.
Time Frame
26 Weeks
Title
Set Maintenance & Shifting
Description
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.
Time Frame
26 Weeks
Title
Reasoning
Description
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.
Time Frame
26 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Burns, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29286983
Citation
Vidoni ED, Perales J, Alshehri M, Giles AM, Siengsukon CF, Burns JM. Aerobic Exercise Sustains Performance of Instrumental Activities of Daily Living in Early-Stage Alzheimer Disease. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):E129-E134. doi: 10.1519/JPT.0000000000000172.
Results Reference
derived
PubMed Identifier
26158265
Citation
Vidoni ED, Johnson DK, Morris JK, Van Sciver A, Greer CS, Billinger SA, Donnelly JE, Burns JM. Dose-Response of Aerobic Exercise on Cognition: A Community-Based, Pilot Randomized Controlled Trial. PLoS One. 2015 Jul 9;10(7):e0131647. doi: 10.1371/journal.pone.0131647. eCollection 2015.
Results Reference
derived

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Dose Response Study of Aerobic Exercise in Older Adults

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