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Dose Response Study of Aerobic Exercise in Older Adults

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Behavioral: Nonexercise control group
Behavioral: Aerobic Exercise Group 1
Behavioral: Aerobic Exercise Group 2
Behavioral: Aerobic Exercise Group 3
Enrollment 101

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description 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. Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Period Title: Overall Study
Started 25 25 27 24
Completed 23 18 21 15
Not Completed 2 7 6 9
Reason Not Completed
Adverse Event             1             2             3             3
Withdrawal by Subject             1             3             1             4
Protocol Violation             0             2             2             2
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3 Total
Hide Arm/Group Description 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. Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days. Total of all reporting groups
Overall Number of Baseline Participants 25 25 27 24 101
Hide Baseline Analysis Population Description
Participants were recruited as a convenience sample of volunteers through print and online advertising, community talks, and existing databases of individuals willing to be in research studies Participants had to be at least 65, sedentary or underactive a, and free of cognitive impairment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 27 participants 24 participants 101 participants
72.5  (5.8) 73.5  (5.9) 72.5  (5.7) 73.2  (5.3) 72.9  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 27 participants 24 participants 101 participants
Female
16
  64.0%
16
  64.0%
17
  63.0%
16
  66.7%
65
  64.4%
Male
9
  36.0%
9
  36.0%
10
  37.0%
8
  33.3%
36
  35.6%
1.Primary Outcome
Title Visuospatial Processing
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description:
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.
Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Overall Number of Participants Analyzed 23 18 21 15
Mean (Standard Error)
Unit of Measure: units on a scale
-.02  (.03) .19  (.03) .08  (.03) .29  (.03)
2.Primary Outcome
Title Change in Maximal Oxygen Consumption
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description:
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.
Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Overall Number of Participants Analyzed 25 25 27 24
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
-1  (1.6) 1.4  (1.5) 1.7  (1.4) 2.0  (1.9)
3.Primary Outcome
Title Change in Physical Performance Test
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description:
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.
Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Overall Number of Participants Analyzed 25 25 27 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
.2  (1.7) .1  (2.0) -.9  (1.9) .5  (2.3)
4.Secondary Outcome
Title Verbal Memory
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels.
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description:
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.
Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Overall Number of Participants Analyzed 23 18 21 15
Mean (Standard Error)
Unit of Measure: units on a standardized scale
.52  (.09) .61  (.09) .47  (.09) .32  (.09)
5.Secondary Outcome
Title Simple Attention
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description:
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.
Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Overall Number of Participants Analyzed 23 18 21 15
Mean (Standard Error)
Unit of Measure: units on a scale
-.06  (.09) .11  (.09) .09  (.09) .14  (.09)
6.Secondary Outcome
Title Set Maintenance & Shifting
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description:
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.
Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Overall Number of Participants Analyzed 23 18 21 15
Mean (Standard Error)
Unit of Measure: units on a scale
.07  (.32) -.08  (.32) .14  (.32) -.13  (.32)
7.Secondary Outcome
Title Reasoning
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description:
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.
Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Overall Number of Participants Analyzed 23 18 21 15
Mean (Standard Error)
Unit of Measure: units on a scale
.24  (.12) .08  (.12) .12  (.12) .21  (.12)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Hide Arm/Group Description 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. Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
All-Cause Mortality
Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)      0/27 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nonexercise Control Group Aerobic Exercise Group 1 Aerobic Exercise Group 2 Aerobic Exercise Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      8/25 (32.00%)      16/27 (59.26%)      15/24 (62.50%)    
Cardiac disorders         
Cardiac [1]  1/25 (4.00%)  1 3/25 (12.00%)  4 6/27 (22.22%)  7 6/24 (25.00%)  7
Infections and infestations         
Infection [2]  0/25 (0.00%)  0 2/25 (8.00%)  2 2/27 (7.41%)  2 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Musculoskeletal Soreness [3]  1/25 (4.00%)  1 6/25 (24.00%)  8 14/27 (51.85%)  31 13/24 (54.17%)  27
Respiratory, thoracic and mediastinal disorders         
Pulmonary [4]  1/25 (4.00%)  1 1/25 (4.00%)  1 0/27 (0.00%)  0 2/24 (8.33%)  2
[1]
Irregular heart rate, angina or EKG change typically seen during cardiopulmonary testing. Events may have been discovered at baseline screening and not attributable to intervention
[2]
Other infection considered to be exacerbated by exercise
[3]
Musculoskeletal Soreness attributed to exercise
[4]
Coughing or upper respiratory infection made worse by exercise
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jeffrey Burns
Organization: University of Kansas Medical Center
Phone: 913-588-0555
Responsible Party: Jeff Burns, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01129115     History of Changes
Other Study ID Numbers: 11883
First Submitted: May 18, 2010
First Posted: May 24, 2010
Results First Submitted: November 4, 2015
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016