Dose Response Study of Aerobic Exercise in Older Adults
NCT01129115, Early phase 1, Completed, Jeff Burns, MD; results first posted 2016-02-15
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Dose Response Study of Aerobic Exercise in Older Adults | ClinicalTrials.gov |
| NCT number | NCT01129115 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Early phase 1 | ClinicalTrials.gov |
| Enrollment | 101 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Jeff Burns, MD | ClinicalTrials.gov |
| Conditions | Alzheimer's Disease | ClinicalTrials.gov |
| Interventions | Nonexercise control group, Aerobic Exercise Group 1, Aerobic Exercise Group 2, Aerobic Exercise Group 3 | ClinicalTrials.gov |
| First posted | 2010-05-24 | ClinicalTrials.gov |
| Last updated | 2016-02-15 | ClinicalTrials.gov |
| Results first posted | 2016-02-15 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Visuospatial Processing | 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. | ClinicalTrials.gov |
| Primary | Change in Maximal Oxygen Consumption | 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 | ClinicalTrials.gov |
| Primary | Change in Physical Performance Test | 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. | ClinicalTrials.gov |
| Secondary | Verbal Memory | 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. | ClinicalTrials.gov |
| Secondary | Simple Attention | 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. | ClinicalTrials.gov |
| Secondary | Set Maintenance & Shifting | 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. | ClinicalTrials.gov |
| Secondary | Reasoning | 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. | ClinicalTrials.gov |
Outcomes 7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| SECONDARY | Verbal Memory | 26 weeks | Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels. | units on a standardized scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Visuospatial Processing | 26 weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Simple Attention | 26 Weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Set Maintenance & Shifting | 26 Weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Reasoning | 26 Weeks | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in Maximal Oxygen Consumption | 26 weeks | ml/kg/min | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in Physical Performance Test | 26 Week | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Verbal Memory | Nonexercise Control Group | .52 | Standard Error .09 | units on a standardized scale | ClinicalTrials.gov | |
| Verbal Memory | Aerobic Exercise Group 1 | .61 | Standard Error .09 | units on a standardized scale | ClinicalTrials.gov | |
| Verbal Memory | Aerobic Exercise Group 2 | .47 | Standard Error .09 | units on a standardized scale | ClinicalTrials.gov | |
| Verbal Memory | Aerobic Exercise Group 3 | .32 | Standard Error .09 | units on a standardized scale | ClinicalTrials.gov | |
| Visuospatial Processing | Nonexercise Control Group | -.02 | Standard Error .03 | units on a scale | ClinicalTrials.gov | |
| Visuospatial Processing | Aerobic Exercise Group 1 | .19 | Standard Error .03 | units on a scale | ClinicalTrials.gov | |
| Visuospatial Processing | Aerobic Exercise Group 2 | .08 | Standard Error .03 | units on a scale | ClinicalTrials.gov | |
| Visuospatial Processing | Aerobic Exercise Group 3 | .29 | Standard Error .03 | units on a scale | ClinicalTrials.gov | |
| Simple Attention | Nonexercise Control Group | -.06 | Standard Error .09 | units on a scale | ClinicalTrials.gov | |
| Simple Attention | Aerobic Exercise Group 1 | .11 | Standard Error .09 | units on a scale | ClinicalTrials.gov | |
| Simple Attention | Aerobic Exercise Group 2 | .09 | Standard Error .09 | units on a scale | ClinicalTrials.gov | |
| Simple Attention | Aerobic Exercise Group 3 | .14 | Standard Error .09 | units on a scale | ClinicalTrials.gov | |
| Set Maintenance & Shifting | Nonexercise Control Group | .07 | Standard Error .32 | units on a scale | ClinicalTrials.gov | |
| Set Maintenance & Shifting | Aerobic Exercise Group 1 | -.08 | Standard Error .32 | units on a scale | ClinicalTrials.gov | |
| Set Maintenance & Shifting | Aerobic Exercise Group 2 | .14 | Standard Error .32 | units on a scale | ClinicalTrials.gov | |
| Set Maintenance & Shifting | Aerobic Exercise Group 3 | -.13 | Standard Error .32 | units on a scale | ClinicalTrials.gov | |
| Reasoning | Nonexercise Control Group | .24 | Standard Error .12 | units on a scale | ClinicalTrials.gov | |
| Reasoning | Aerobic Exercise Group 1 | .08 | Standard Error .12 | units on a scale | ClinicalTrials.gov | |
| Reasoning | Aerobic Exercise Group 2 | .12 | Standard Error .12 | units on a scale | ClinicalTrials.gov | |
| Reasoning | Aerobic Exercise Group 3 | .21 | Standard Error .12 | units on a scale | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Nonexercise Control Group | 25 | ClinicalTrials.gov | |
| Overall Study | STARTED | Aerobic Exercise Group 1 | 25 | ClinicalTrials.gov | |
| Overall Study | STARTED | Aerobic Exercise Group 2 | 27 | ClinicalTrials.gov | |
| Overall Study | STARTED | Aerobic Exercise Group 3 | 24 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Nonexercise Control Group | 23 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Aerobic Exercise Group 1 | 18 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Aerobic Exercise Group 2 | 21 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Aerobic Exercise Group 3 | 15 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Nonexercise Control Group | 2 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Aerobic Exercise Group 1 | 7 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Aerobic Exercise Group 2 | 6 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Aerobic Exercise Group 3 | 9 | ClinicalTrials.gov |
Adverse events 16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Musculoskeletal Soreness | Musculoskeletal and connective tissue disorders | Nonexercise Control Group | 1 | 25 | 1 | ClinicalTrials.gov |
| other | Musculoskeletal Soreness | Musculoskeletal and connective tissue disorders | Aerobic Exercise Group 1 | 6 | 25 | 8 | ClinicalTrials.gov |
| other | Musculoskeletal Soreness | Musculoskeletal and connective tissue disorders | Aerobic Exercise Group 2 | 14 | 27 | 31 | ClinicalTrials.gov |
| other | Musculoskeletal Soreness | Musculoskeletal and connective tissue disorders | Aerobic Exercise Group 3 | 13 | 24 | 27 | ClinicalTrials.gov |
| other | Cardiac | Cardiac disorders | Nonexercise Control Group | 1 | 25 | 1 | ClinicalTrials.gov |
| other | Cardiac | Cardiac disorders | Aerobic Exercise Group 1 | 3 | 25 | 4 | ClinicalTrials.gov |
| other | Cardiac | Cardiac disorders | Aerobic Exercise Group 2 | 6 | 27 | 7 | ClinicalTrials.gov |
| other | Cardiac | Cardiac disorders | Aerobic Exercise Group 3 | 6 | 24 | 7 | ClinicalTrials.gov |
| other | Pulmonary | Respiratory, thoracic and mediastinal disorders | Nonexercise Control Group | 1 | 25 | 1 | ClinicalTrials.gov |
| other | Pulmonary | Respiratory, thoracic and mediastinal disorders | Aerobic Exercise Group 1 | 1 | 25 | 1 | ClinicalTrials.gov |
| other | Pulmonary | Respiratory, thoracic and mediastinal disorders | Aerobic Exercise Group 2 | 0 | 27 | 0 | ClinicalTrials.gov |
| other | Pulmonary | Respiratory, thoracic and mediastinal disorders | Aerobic Exercise Group 3 | 2 | 24 | 2 | ClinicalTrials.gov |
| other | Infection | Infections and infestations | Nonexercise Control Group | 0 | 25 | 0 | ClinicalTrials.gov |
| other | Infection | Infections and infestations | Aerobic Exercise Group 1 | 2 | 25 | 2 | ClinicalTrials.gov |
| other | Infection | Infections and infestations | Aerobic Exercise Group 2 | 2 | 27 | 2 | ClinicalTrials.gov |
| other | Infection | Infections and infestations | Aerobic Exercise Group 3 | 0 | 24 | 0 | ClinicalTrials.gov |
Adverse event totals 12
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Nonexercise Control Group | ClinicalTrials.gov | ||
| Total, all-cause mortality | Aerobic Exercise Group 1 | ClinicalTrials.gov | ||
| Total, all-cause mortality | Aerobic Exercise Group 2 | ClinicalTrials.gov | ||
| Total, all-cause mortality | Aerobic Exercise Group 3 | ClinicalTrials.gov | ||
| Total, other adverse events | Nonexercise Control Group | 2 | 25 | ClinicalTrials.gov |
| Total, other adverse events | Aerobic Exercise Group 1 | 8 | 25 | ClinicalTrials.gov |
| Total, other adverse events | Aerobic Exercise Group 2 | 16 | 27 | ClinicalTrials.gov |
| Total, other adverse events | Aerobic Exercise Group 3 | 15 | 24 | ClinicalTrials.gov |
| Total, serious adverse events | Nonexercise Control Group | 0 | 25 | ClinicalTrials.gov |
| Total, serious adverse events | Aerobic Exercise Group 1 | 0 | 25 | ClinicalTrials.gov |
| Total, serious adverse events | Aerobic Exercise Group 2 | 0 | 27 | ClinicalTrials.gov |
| Total, serious adverse events | Aerobic Exercise Group 3 | 0 | 24 | ClinicalTrials.gov |
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)