Trial · NCT04544358
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 27 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Cerebral Functional Connectivity - Default Mode Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the "networks.nii" (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Secondary | Cerebral Functional Connectivity - Frontoparietal Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the "networks.nii" (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Secondary | Cerebral Functional Connectivity - Salience Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the "networks.nii" (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Secondary | Cerebral Functional Connectivity - Language Network | Baseline and 4 months (follow up) | Functional connectivity is defined as a correlation of the blood oxygenation level dependent (BOLD) signal from each brain network defined by prespecified regions of interest. Whole-brain images were acquired on a GE MR 750 Discovery 3-T scanner using an 8-channel head coil. Functional connectomes were generated using the resting state functional magnetic resonance imaging (fMRI) toolbox. Using the "networks.nii" (with ROIs defined from CONN's ICA analyses of HCP dataset/497 subjects), functional brain networks (e.g., DMN, FPN, SAL, and language) were derived using pairwise BOLD signal correlations, which were then converted to z-scores using Fisher's r-to-z transformation. The DMN, FPN, and SAL were selected as networks of interest due to evidence of the effects of aging and PA on these networks. The language network was selected as a control network. |
| Secondary | Trail Making Test (TMT) Part B | Baseline and 4 months (follow up) | Measure of executive function. In part A, the subject connects a series of encircled numbers in numerical order. In part B, the subject connects encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. TMT score is the time in seconds it takes the subject to complete the test. A lower score/time is better. TMT A scores range from 0-180 seconds and TMT B scores range from 0-300 seconds. Raw scores were converted to z-scores utilizing baseline means and standard deviations. Z-scores were then combined into composite scores of executive function. |
| Secondary | Verbal Fluency Test - Fruits and Vegetables | Baseline and 4 months (follow up) | This is a widely used measure of verbal fluency (or semantic memory) in which the participant is asked to generate exemplars of each of two categories (animals, fruits and vegetables) within a 60-second time limit. The primary measure of performance is the number of unique exemplars generated within the time limit. The score is the total number of animals (Animal Total) and vegetables (Vegetable Total) named within the time limit. A higher score means a better outcome. Scores range from 0 with no upper limit. |
| Secondary | Digit Span Test - Backward | Baseline and 4 months (follow up) | This is a widely used measure of working memory (or attention) in which the participant is read number sequences of increasing length and then asked to repeat each sequence forward (Digits Forward) or backward (Digits Backward). The primary measure of performance is the number of digit sequences correctly recalled in each subpart (Digits Forward, Digits Backward). Each sequence for Digits Forward and Digits Backward is scored as error (0) or correct (1) - a higher score means a better outcome. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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