The Influence of the Otago Exercise Program on Executive Function Among People Living With Mild to Moderate Dementia
NCT05488951, Not applicable, Unknown, Augusta University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Influence of the Otago Exercise Program on Executive Function Among People Living With Mild to Moderate Dementia | ClinicalTrials.gov |
| NCT number | NCT05488951 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 42 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Augusta University | ClinicalTrials.gov |
| Conditions | Dementia | ClinicalTrials.gov |
| Interventions | Otago Exercise Program | ClinicalTrials.gov |
| First posted | 2022-08-05 | ClinicalTrials.gov |
| Last updated | 2023-01-31 | ClinicalTrials.gov |
Registered outcomes 59
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in the Color Word Stroop Test | Baseline, 6 months | Response inhibition involves deliberately suppressing dominant, automatic, or prepotent responses, and will be assessed using the Stroop Colour-Word Test. For the Stroop Test, there will be three conditions. First, participants will be asked to read aloud words printed in black ink (e.g., BLUE). Second, they were instructed to read aloud the color of colored rectangles. Finally, they will shown a page of color-words printed in incongruent colored ink (e.g., the word "BLUE" printed in red ink). Participants will be asked to name the ink color in which the words are printed (while ignoring the word itself). There will 50 trials for each condition and the time taken to read each condition will recorded. | ClinicalTrials.gov |
| Secondary | Change in the Digit Symbol Substitution Test | Baseline, 6 months | The Digit Symbol Substitution Test is a measure of processing speed and consists of nine digit-symbol pairs. Participants will be asked to fill in as many corresponding symbols for the given digits within 90 s, with a greater number of items correctly coded indicating better processing speed. Performance will be measured by the number of correct symbols; a greater number of symbols indicates better performance. | ClinicalTrials.gov |
| Secondary | Change in the oral Trail Making Test | Baseline, 6 months | Set-shifting will be assessed using the oral Trail-Making Test Part B minus A. It will involve going back and forth between multiple tasks or mental sets. Part A will assess psychomotor speed; participants will count numbers aloud in sequential order, starting at 1 and ending at 25. We will record the amount of time (in seconds) for the participants to complete the task. Part B will consist of orally switching back and forth from numbers to letters (the numbers extend from 1 to 13 and the letters from A to L). Participants will be instructed to orally count as quickly and as accurately as possible from 1 to A, A to 2, 2 to B, B to 3, and so on, until they complete the task. We will record the amount of time (in seconds) for participants to complete the task. To index set shifting, the completion time difference between Part B and Part A will be calculated. Smaller difference scores indicate better set shifting. | ClinicalTrials.gov |
| Secondary | Change in the Digit Span Forwards and Backwards | Baseline, 6 months | Working memory will be assessed using the verbal digit span forward and backward task. This task involves presenting a series of random digits (from 1 to 9), after which participants will be asked to verbally repeat the list in the same order and in the reverse order, respectively, in separate trials. If successful, they will be provided a longer number sequence. The total number of correct trials and the longest correct trial will be recorded. | ClinicalTrials.gov |
| Secondary | Change in the Rey Auditory Verbal Learning Test | Baseline, 6 months | The Rey Auditory Verbal Learning Test is a measure of learning and short-term memory. We will read a list of 15 words and participants will be asked to recall as many words as they can remember. We will record the total recall, intrusions, and repetitions for: immediate recall, delayed recall, and word recognition. | ClinicalTrials.gov |
| Secondary | Change in the Benton Judgement of Line Orientation | Baseline, 6 months | Perception will be assessed using the Benton Judgement of Line Orientation. Participants will be presented with 15 pairs of lines. Participants will judge the angle of both lines with respect to the reference line angle. The total score ranges from 0 to 15. | ClinicalTrials.gov |
| Secondary | Change in the Boston Naming Test | Baseline, 6 months | Language skills will be assessed with the Boston Naming Test, which involves visually looking at 15 printed pictures on a piece of paper and verbalizing the name of the objects. The total score ranges from 0 to 15. | ClinicalTrials.gov |
| Secondary | Change in Health Utilities Index-3 | Baseline, 6 months | The Health Utilities Index-3 is a questionnaire related to quality of life. We will use the total score as the outcome measure. | ClinicalTrials.gov |
| Secondary | Change in the Visual Analogue Scale | Baseline, 6 months | The Visual Analogue Scale (VAS) is a measure of overall perceived rating of health. The endpoint of 100 is labelled "The best health you can imagine" while a score of 0 was labelled "The worse health you can imagine". Participants will be asked to report their perceived health on the day of the assessment. | ClinicalTrials.gov |
| Secondary | Change in the Geriatric Depression Scale | Baseline, 6 months | The Geriatric Depression Scale is a 15-item questionnaire that assesses depressed mood. A score of greater than 5 points is suggestive of depression, while a score of greater than or equal to a score of 10 is almost always indicative of depression. | ClinicalTrials.gov |
| Secondary | Change in the short-Falls Efficacy Scale International | Baseline, 6 months | The Short-Falls Efficacy Scale International measures fear when performing 7 daily activities. Scores between 7-8 are indicative of low concern for falling, 9-13 are indicative of moderate concern for falling, and 14-28 are indicative of high concern for falling. | ClinicalTrials.gov |
| Secondary | Change in Functional Comorbidity Index | Baseline, 6 months | The Functional Comorbidity Index includes 18 evenly weighted comorbidities that stratify on physical functional status. This scale's score was the total number of comorbidities. | ClinicalTrials.gov |
| Secondary | Change in body composition (weight (kg)) | Baseline, 6 months | Change in body composition will be measured using the Omron Body Composition Monitor. We will record weight (kg). | ClinicalTrials.gov |
| Secondary | Change in body composition (fat (%)) | Baseline, 6 months | Change in body composition will be measured using the Omron Body Composition Monitor. We will record body fat composition (%). | ClinicalTrials.gov |
| Secondary | Change in body composition (muscle (%)) | Baseline, 6 months | Change in body composition will be measured using the Omron Body Composition Monitor. We will record skeletal muscle composition (%). | ClinicalTrials.gov |
| Secondary | Change in the Short Physical Performance Battery | Baseline, 6 months | The Short Physical Performance Battery is a valid and reliable measure of physical performance and is comprised of three components, including: balance, gait, and chair stands. Balance will be assessed over 10 s of stance with feet together, semi-tandem, and tandem stance. Gait speed will be measured over 4 m with a stopwatch. The five times sit to stand will be measured with a stopwatch. The total score ranges from 0 worst) to 12 (best). | ClinicalTrials.gov |
| Secondary | Change in dual-task posture (sway area (degrees/s squared)) | Baseline, 6 months | Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine sway area (degrees/s squared). | ClinicalTrials.gov |
| Secondary | Change in dual-task posture (root mean square sway (degrees)) | Baseline, 6 months | Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine root mean square sway (degrees). | ClinicalTrials.gov |
| Secondary | Change in dual-task posture (frequency of sway (Hz)) | Baseline, 6 months | Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine frequency of sway (Hz). | ClinicalTrials.gov |
| Secondary | Change in dual-task posture (jerk (m²/s^5)) | Baseline, 6 months | Dual-task posture will be measured with APDM inertial sensors. Dual-task posture will involve standing with feet apart with no cognitive task, as well as while counting backwards by 1's. We will examine jerk (m²/s\^5). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
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 7
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 |
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | 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)