Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG057552 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Johns Hopkins University | OTHER |
| Marquette University | OTHER |
| University of Maryland, Baltimore |
Not provided
Not provided
Not provided
Not provided
The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Training | Experimental | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
|
| Flexibility Control | Active Comparator | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Other | Supervised exercise conducted four days per week for six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rey Auditory Verbal Learning Test Sum of Trials 1-5 | Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded. | Baseline and 6 months |
| Famous Name Discrimination fMRI Activation | Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Rate of Oxygen Consumption (VO2peak) | Estimated peak rate of oxygen consumption during a treadmill graded exercise test, a measure of cardiorespiratory fitness. | Baseline and 6 months |
| 6 Minute Walk Test |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J. Carson Smith, PhD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Department of Kinesiology | College Park | Maryland | 20742 | United States |
After informed consent, all physician consent and MRI screening forms were completed (approximately 2-6 weeks) before baseline testing was scheduled. Participants were then assigned to a treatment arm and completed the baseline testing. A total of 124 participants completed baseline, and 5 withdrew before starting the intervention. 119 started one of the two arms, and 106 of the 124 consented individuals completed the entire 6-month exercise intervention with baseline and follow-up testing.
Advertising and recruitment resulted in 5,284 online pre-screening surveys, which led to 266 individuals who volunteered and completed the in-person informed consent visit. Among the 266 consented individuals, 117 (44%) were determined to not meet the inclusion/exclusion criteria, with the most common reason being identification of cognitive impairment, and 25 voluntarily withdrew from the study, leaving 124 who completed baseline testing. 106 of 124 completed the entire protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Training | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
| FG001 | Flexibility Control | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Training | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rey Auditory Verbal Learning Test Sum of Trials 1-5 | Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded. | These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing. | Posted | Mean | Standard Deviation | Sum of words recalled Trials 1 to 5 | Baseline and 6 months |
|
From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Training | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fainted | General disorders | Systematic Assessment | Unrelated to the intervention. Reported by participant, while standing at home the participant turned to take a step and blacked out for a few seconds. Went to ER. Given IV fluids. No diagnosis provided. Continued to participate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated joint/muscle injury/pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to intervention. Participant reported mild joint and/or muscle pain |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Carson Smith, PhD | University of Maryland at College Park | +1 (301) 405-0344 | carson@umd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2025 | Jan 20, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2025 | Apr 10, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Participants and outcomes assessors are masked to APOE genotype. We do not share any data with care providers.
| Flexibility Control | Other | Supervised exercise conducted four days per week for six months. |
|
Distance walked in 6 minutes
| Baseline and 6 months |
| BG001 |
| Flexibility Control |
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing. | Count of Participants | Participants |
|
| Education | Self-reported level of education attainment | These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing. | Count of Participants | Participants |
|
|
|
| Primary | Famous Name Discrimination fMRI Activation | Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions. | These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing. | Posted | Mean | Standard Error | BOLD intensity (standardized beta) | Baseline and 6 months |
|
|
|
| Secondary | Peak Rate of Oxygen Consumption (VO2peak) | Estimated peak rate of oxygen consumption during a treadmill graded exercise test, a measure of cardiorespiratory fitness. | These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing. | Posted | Mean | Standard Error | Liters per minute | Baseline and 6 months |
|
|
|
| Secondary | 6 Minute Walk Test | Distance walked in 6 minutes | These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing. | Posted | Mean | Standard Error | Feet, Distance walked in 6 minutes | Baseline and 6 months |
|
|
|
| 0 |
| 64 |
| 3 |
| 64 |
| 10 |
| 64 |
| EG001 | Flexibility Control | Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks. | 0 | 55 | 1 | 55 | 8 | 55 |
|
| Surgical Procedure | General disorders | Systematic Assessment | Unrelated to intervention. Reported by the participant. A surgical procedure disrupted participation. Participant continued to participate after recovery. |
|
| Fall | General disorders | Systematic Assessment | Unrelated to intervention. Reported by participant. At home, participant leaned to reach for something on the floor and lost balance and fell out of her chair. Continued to participate. |
|
|
| Fall off of yoga ball | General disorders | Systematic Assessment | Related to intervention. Participant was seated on a yoga ball during the exercise class and fell off. No treatment needed. |
|
| Mild joint/muscle pain during exercise | Musculoskeletal and connective tissue disorders | Systematic Assessment | Related to the intervention. Participant reported mild muscle or joint pain during an exercise session. Stopped exercise and rested. |
|
| Discomfort after MRI scan | General disorders | Systematic Assessment | Unrelated to intervention. Participant reported mild vertigo immediately after the MRI scan. No treatment needed, resolved. |
|
| Minor medical procedure that led to short-term disruption of participation | General disorders | Systematic Assessment | Unrelated to the intervention. Reported by the participant. Participation continued after recovery from procedure. |
|
| Fall at home, no injury | General disorders | Systematic Assessment | Unrelated to intervention. Participant reported mild fall at home, no injury, no treatment needed. Participation continued. |
|
| Mild dizziness after fasting blood draw | General disorders | Systematic Assessment | Unrelated to intervention. Participant reported mild dizziness after fasting blood draw. Seated rest, fluids, snack provided. Resolved and no follow-up needed. |
|
Not provided
Not provided
Not provided