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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonexercise control group | Active Comparator |
| |
| Aerobic Exercise Group 1 | Experimental |
| |
| Aerobic Exercise Group 2 | Experimental |
| |
| Aerobic Exercise Group 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonexercise control group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 26 weeks |
| 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 | 26 weeks |
| 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. | 26 Week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Burns, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29286983 | Derived | 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. | |
| 26158265 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonexercise Control Group | 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. |
| FG001 | Aerobic Exercise Group 1 | Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. |
| FG002 | Aerobic Exercise Group 2 | Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days |
| FG003 | Aerobic Exercise Group 3 | Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonexercise Control Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels. | Posted | Mean | Standard Error | units on a standardized scale | 26 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonexercise Control Group | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal Soreness | Musculoskeletal and connective tissue disorders | Musculoskeletal Soreness attributed to exercise |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Burns | University of Kansas Medical Center | 913-588-0555 | kuamp@kumc.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Aerobic Exercise Group 1 | Behavioral | The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. |
|
| Aerobic Exercise Group 2 | Behavioral | The 100% group will perform 150 minutes a week of exercise over 3 - 5 days |
|
| Aerobic Exercise Group 3 | Behavioral | The 150% group will perform 225 minutes a week of exercise over 4 - 5 days. |
|
| 26 weeks |
| 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. | 26 Weeks |
| 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. | 26 Weeks |
| 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. | 26 Weeks |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG001 | Aerobic Exercise Group 1 | Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. |
| BG002 | Aerobic Exercise Group 2 | Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days |
| BG003 | Aerobic Exercise Group 3 | Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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.
| OG001 | Aerobic Exercise Group 1 | Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. |
| OG002 | Aerobic Exercise Group 2 | Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days |
| OG003 | Aerobic Exercise Group 3 | Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days. |
|
|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 26 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 26 Weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 26 Weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 26 Weeks |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | ml/kg/min | 26 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 26 Week |
|
|
|
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | Aerobic Exercise Group 1 | Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days. | 0 | 25 | 8 | 25 |
| EG002 | Aerobic Exercise Group 2 | Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days | 0 | 27 | 16 | 27 |
| EG003 | Aerobic Exercise Group 3 | Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days. | 0 | 24 | 15 | 24 |
|
| Cardiac | Cardiac disorders | 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 |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Coughing or upper respiratory infection made worse by exercise |
|
| Infection | Infections and infestations | Other infection considered to be exacerbated by exercise |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |