Independent Walking for Brain Health
NCT03058146, Not applicable, Terminated, University of California, San Diego; results first posted 2023-07-17
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Independent Walking for Brain Health | ClinicalTrials.gov |
| NCT number | NCT03058146 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 53 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of California, San Diego | ClinicalTrials.gov |
| Conditions | Physical Activity, Aging | ClinicalTrials.gov |
| Interventions | Mobile Health Walking Condition, Healthy Aging Education Condition | ClinicalTrials.gov |
| First posted | 2017-02-20 | ClinicalTrials.gov |
| Last updated | 2023-07-17 | ClinicalTrials.gov |
| Results first posted | 2023-07-17 | ClinicalTrials.gov |
| Limitations and caveats | Due to the COVID-19 pandemic, recruitment was terminated early, leading to a smaller than expected sample. As such, results are presented as descriptive statistics for pre and post intervention time points. | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Pre (baseline) and post (3 months) | Average minutes per day spent in moderate to vigorous levels of physical activity (MVPA) (defined as =\>1952 accelerometer counts per minute). MVPA minutes were determined based on one-week of accelerometer wear on the hip at baseline and post intervention. | ClinicalTrials.gov |
| Secondary | Cerebral Blood Flow (Hippocampal and Frontal) | Pre (baseline) and post (3 months) | Average cerebral blood flow measured with arterial spin labeling magnetic resonance imaging in ml/100g/min. Cerebral blood flow was obtained via arterial spin labeling MRI and Freesurfer software was utilized to delineate regions of interest for each participant (right and left regions were averaged). For the frontal lobe cerebral blood flow we averaged the mean of superior frontal, rostral and caudal middle frontal, pars opercularis, pars triangularis, pars orbitalis, lateral and medial orbitofrontal, precentral, paracentral, and frontal pole. | ClinicalTrials.gov |
| Other | Memory Function | Pre (baseline) and post (3 months) | A memory composite score was created by converting raw scores into z-scores and then averaging them for the following tests: Rey Auditory Verbal Learning Test trials 1 to 5, trial 6 (short-delay free recall), and delayed recall; Wechsler Memory Scale - Revised Logical Memory I and II (immediate and delayed recall scores). Z-scores were calculated using raw scores for these tests in the entire sample \[(raw score-mean of the sample)/standard deviation of the sample\]. Z-scores of 0 represent the sample's mean performance on the tests, z-scores \>0 indicate better performance compared to the sample's mean, while z-scores \<0 indicate worse performance compared to the sample's mean. | ClinicalTrials.gov |
| Other | Executive Function | Pre (baseline) and post (3 months) | An executive function composite score was created by converting raw scores into z-scores and then averaging them for the following tests: Trail Making Test Part B minus Trail Making Test Part A, Golden version of the Stroop Color Word Trial, and verbal fluency (letters F,A,S). Trail making test scores were reversed prior to averaging, so higher scores = better performance. Z-scores were calculated using raw scores for these tests in the entire sample \[(raw score-mean of the sample)/standard deviation of the sample\]. Z-scores of 0 represent the sample's mean performance on the tests, z-scores \>0 indicate better performance compared to the sample's mean, while z-scores \<0 indicate worse performance compared to the sample's mean. | ClinicalTrials.gov |
| Other | Cardiorespiratory Fitness | Pre (baseline) and post (3 months) | Total time it takes the participant to reach 85% of their estimated maximal heart rate (220-age) measured via sub-maximal treadmill test in seconds. | ClinicalTrials.gov |
Outcomes 5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Pre (baseline) and post (3 months) | All participants who were randomized and completed the baseline sessions were included in the analyses (N=43). | average minutes per day | MEAN | ClinicalTrials.gov |
| SECONDARY | Cerebral Blood Flow (Hippocampal and Frontal) | Pre (baseline) and post (3 months) | We provide descriptive statistics for pre and post cerebral blood flow in the hippocampus and frontal cortex. | ml/100g/minute | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Memory Function | Pre (baseline) and post (3 months) | All participants completed neuropsychological testing at pre and post. | z-score | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Executive Function | Pre (baseline) and post (3 months) | All participants were included and descriptive statistics are presented for pre and post. | z-score | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Cardiorespiratory Fitness | Pre (baseline) and post (3 months) | Descriptive data are presented for pre and post. | seconds | MEAN | ClinicalTrials.gov |
Results by group 24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Physical Activity Condition | Pre MVPA average minutes per day | 26.37 | Standard Deviation 17.31 | average minutes per day | ClinicalTrials.gov |
| Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Healthy Aging Education Condition | Pre MVPA average minutes per day | 21.34 | Standard Deviation 17.44 | average minutes per day | ClinicalTrials.gov |
| Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Physical Activity Condition | Post MVPA average minutes per day | 44.09 | Standard Deviation 25.28 | average minutes per day | ClinicalTrials.gov |
| Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Healthy Aging Education Condition | Post MVPA average minutes per day | 25.28 | Standard Deviation 15.99 | average minutes per day | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Mobile Health Walking Condition | Pre hippocampal cerebral blood flow | 40.4 | Standard Deviation 10.82 | ml/100g/minute | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Healthy Aging Education Condition | Pre hippocampal cerebral blood flow | 41.03 | Standard Deviation 12.24 | ml/100g/minute | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Mobile Health Walking Condition | Post hippocampal cerebral blood flow | 35.36 | Standard Deviation 5.56 | ml/100g/minute | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Healthy Aging Education Condition | Post hippocampal cerebral blood flow | 40.99 | Standard Deviation 9.1 | ml/100g/minute | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Mobile Health Walking Condition | Pre frontal cerebral blood flow | 45.52 | Standard Deviation 11.58 | ml/100g/minute | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Healthy Aging Education Condition | Pre frontal cerebral blood flow | 47.24 | Standard Deviation 10.46 | ml/100g/minute | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Mobile Health Walking Condition | Post frontal cerebral blood flow | 41.31 | Standard Deviation 7.41 | ml/100g/minute | ClinicalTrials.gov |
| Cerebral Blood Flow (Hippocampal and Frontal) | Healthy Aging Education Condition | Post frontal cerebral blood flow | 46.96 | Standard Deviation 10.7 | ml/100g/minute | ClinicalTrials.gov |
| Memory Function | Physical Activity Condition | Pre memory score | .08 | Standard Deviation .8 | z-score | ClinicalTrials.gov |
| Memory Function | Healthy Aging Education Condition | Pre memory score | -.07 | Standard Deviation .82 | z-score | ClinicalTrials.gov |
| Memory Function | Physical Activity Condition | Post memory score | -.10 | Standard Deviation .94 | z-score | ClinicalTrials.gov |
| Memory Function | Healthy Aging Education Condition | Post memory score | .09 | Standard Deviation .68 | z-score | ClinicalTrials.gov |
| Executive Function | Physical Activity Condition | Pre executive function score | .15 | Standard Deviation .69 | z-score | ClinicalTrials.gov |
| Executive Function | Healthy Aging Education Condition | Pre executive function score | -.14 | Standard Deviation .80 | z-score | ClinicalTrials.gov |
| Executive Function | Physical Activity Condition | Post executive function score | .07 | Standard Deviation .73 | z-score | ClinicalTrials.gov |
| Executive Function | Healthy Aging Education Condition | Post executive function score | -.06 | Standard Deviation .84 | z-score | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Physical Activity Condition | 21 | ClinicalTrials.gov | |
| Overall Study | STARTED | Healthy Aging Education Condition | 23 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Physical Activity Condition | 17 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Healthy Aging Education Condition | 21 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Physical Activity Condition | 4 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Healthy Aging Education Condition | 2 | ClinicalTrials.gov |
Adverse events 10
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 | Non serious adverse event | Renal and urinary disorders | Physical Activity Condition | 1 | 21 | 1 | ClinicalTrials.gov |
| other | Non serious adverse event | Renal and urinary disorders | Healthy Aging Education Condition | 0 | 22 | 0 | ClinicalTrials.gov |
| other | Non serious adverse event | Eye disorders | Physical Activity Condition | 1 | 21 | 1 | ClinicalTrials.gov |
| other | Non serious adverse event | Eye disorders | Healthy Aging Education Condition | 0 | 22 | 0 | ClinicalTrials.gov |
| other | Non serious adverse event | Musculoskeletal and connective tissue disorders | Physical Activity Condition | 1 | 21 | 1 | ClinicalTrials.gov |
| other | Non serious adverse event | Musculoskeletal and connective tissue disorders | Healthy Aging Education Condition | 0 | 22 | 0 | ClinicalTrials.gov |
| other | Non serious adverse event | Social circumstances | Physical Activity Condition | 0 | 21 | 0 | ClinicalTrials.gov |
| other | Non serious adverse event | Social circumstances | Healthy Aging Education Condition | 1 | 22 | 1 | ClinicalTrials.gov |
| other | Non serious adverse event | Social circumstances | Physical Activity Condition | 0 | 21 | 0 | ClinicalTrials.gov |
| other | Non serious adverse event | Social circumstances | Healthy Aging Education Condition | 1 | 22 | 1 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Physical Activity Condition | 0 | 21 | ClinicalTrials.gov |
| Total, all-cause mortality | Healthy Aging Education Condition | 0 | 22 | ClinicalTrials.gov |
| Total, other adverse events | Physical Activity Condition | 3 | 21 | ClinicalTrials.gov |
| Total, other adverse events | Healthy Aging Education Condition | 2 | 22 | ClinicalTrials.gov |
| Total, serious adverse events | Physical Activity Condition | 0 | 21 | ClinicalTrials.gov |
| Total, serious adverse events | Healthy Aging Education Condition | 0 | 22 | ClinicalTrials.gov |
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 1
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 |
|---|---|---|---|---|---|---|
| K23AG049906 | A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition | ZLATAR, ZVINKA ZOE | UNIVERSITY OF CALIFORNIA, SAN DIEGO | NATIONAL INSTITUTE ON AGING | 2016 to 2022 | NIH RePORTER |
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Physical Activity Condition vs Healthy Aging Education Condition: deaths from any cause | Trial comparisons |
| Physical Activity Condition vs Healthy Aging Education Condition: serious adverse events | Trial comparisons |
Tests 6
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 |
|---|---|---|
| Short Story Recall | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Trail Making Test B | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
| Verbal Learning | Other 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)