Trial · NCT07890623
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phybrata power | At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6) | Change in Phybrata power from pretreatment to completion of the 6-week course, calculated from head-mounted accelerometers recording a 60-second standing assessment under different standing balance conditions (mCTSIB; floor yes open, floor eyes closed, compliant surface eyes open, compliant surface eyes closed). Values are expressed in watts taking the sum of the squared acceleration of the tri-axial accelerometer multiplied by a time scaling factor. Lower values indicate less sway, a negative change indicates improved performance. The primary comparison is active vs sham nEVS, adjusted for pretreatment performance. |
| Secondary | Gait speed | At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6) | Change in overground gait speed in metres per second over a 25-foot course. Speed equals distance divided by walking time. Higher values indicate faster walking. |
| Secondary | Timed-up-and-go | At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6) | Change in time, in seconds, to stand from a chair, walk 3 metres at a self selected pace, turn, return to the chair, and sit. Usual walking aids are permitted and recorded. Lower completion time indicates faster functional mobility. |
| Secondary | Short Physical Performance Battery total score | At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6) | Change in short physical performance battery (SPPB) total score. Standardized standing balance, usual-pace walking, and repeated chair0rise components contribute 0-4 points, giving a total score from 0-12. Higher scores indicate better physical performance. |
| Secondary | Grip strength | At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6) | Change in hand-grip strength in kilograms, measured using acalibrated hand dynameter in a standardized seated position. Two valid attempts are recorded. The participants best score is used for analysis. Higher values indicate greater grip strength. |
| Secondary | PROMIS Global Physical Health Score | Immediately before the first EVS or sham session and at completion of the six-week course. | Change in physical health assessed using the PROMIS Global Health v1.2 questionnaire. The four-item physical health raw score will be converted to a T-score using the official scoring tables. T-scores range from 16.2 to 67.7, with higher scores indicating better physical health. Change will be calculated as the end-of-course score minus the pretreatment score; positive values indicate improvement |
| Secondary | PROMIS Global Mental Health Score | Immediately before the first EVS or sham session and at completion of the six-week course. | Change in mental health assessed using the PROMIS Global Health v1.2 questionnaire. The four-item mental health raw score will be converted to a T-score using the official scoring tables. T-scores range from 21.2 to 67.6, with higher scores indicating better mental health. Change will be calculated as the end-of-course score minus the pretreatment score; positive values indicate improvement. |
| Secondary | Distribution of EQ 5D 5L Mobility Response Levels | Immediately before the first EVS or sham session and at completion of the six-week course. | Number and percentage of participants in each response level of the EQ-5D-5L mobility dimension at each assessment. The dimension concerns walking about. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately. |
| Secondary | Distribution of EQ 5D 5L Self Care Response Levels | Immediately before the first EVS or sham session and at completion of the six-week course | Number and percentage of participants in each response level of the EQ-5D-5L self care dimension at each assessment. The dimension concerns washing or dressing. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately. |
| Secondary | Distribution of EQ 5D 5L Usual Activities Response Levels | Immediately before the first EVS or sham session and at completion of the six-week course | Number and percentage of participants in each response level of the EQ-5D-5L usual activities dimension at each assessment. The dimension concerns usual daily activities. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately. |
| Secondary | Distribution of EQ 5D 5L Pain or Discomfort Response Levels | Immediately before the first EVS or sham session and at completion of the six-week course | Number and percentage of participants in each response level of the EQ-5D-5L pain or discomfort dimension at each assessment. The dimension concerns pain or discomfort. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately. |
| Secondary | Distribution of EQ 5D 5L Anxiety or Depression Response Levels | Immediately before the first EVS or sham session and at completion of the six-week course | Number and percentage of participants in each response level of the EQ-5D-5L anxiety or depression dimension at each assessment. The dimension concerns anxiety or depression. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately. |
| Secondary | Mean Change in M2C2 Symbol Search Response Time | Immediately before the first EVS or sham session and at completion of the six-week course. | Change in processing speed assessed using the Mobile Monitoring of Cognitive Change (M2C2) Symbol Search task. Participants identify matching symbol pairs as quickly and accurately as possible. The participant-level score is the median response time, in milliseconds, across valid correct test trials. Lower values indicate faster processing speed. Change will be calculated as the end-of-course score minus the pretreatment score; negative values indicate improvement. |
| Secondary | Mean Change in M2C2 Grid Memory Spatial Recall Error | Immediately before the first EVS or sham session and at completion of the six-week course. | Change in visuospatial working memory assessed using the M2C2 Grid Memory task. Participants recall previously displayed dot locations following a brief distraction task. The participant-level score is the mean trial-level Euclidean distance error between recalled and original dot locations. A score of zero indicates no spatial recall error; lower values indicate better performance. Change will be calculated as the end-of-course score minus the pretreatment score; negative values indicate improvement. |
| Secondary | Mean Change in M2C2 Color Dots Recall Accuracy | Immediately before the first EVS or sham session and at completion of the six-week course. | Change in visual working memory and color-location binding assessed using the M2C2 Color Dots task. Participants recall the colors and locations of previously presented dots. Accuracy will be calculated as the number of correct recall responses divided by the total number of scorable recall responses across the color and location phases, multiplied by 100, using the task version's scoring criteria. Scores range from 0% to 100%, with higher scores indicating better performance. Change will be calculated as the end-of-course percentage minus the pretreatment percentage; positive changes indicate improvement. |
| Secondary | Mean Change in M2C2 Color Shapes Accuracy | Immediately before the first EVS or sham session and at completion of the six-week course. | Change in visual working memory and color-shape binding assessed using the M2C2 Color Shapes task. Participants identify whether previously presented color-shape combinations remain unchanged or have changed. Accuracy will be calculated as the number of correct responses divided by the total number of scorable test responses, multiplied by 100. Scores range from 0% to 100%, with higher scores indicating better performance. Change will be calculated as the end-of-course percentage minus the pretreatment percentage; positive changes indicate improvement. |
| Other | Number of Assigned EVS or Sham Sessions Completed | From the first assigned session through completion of the six-week EVS or sham course | Number of assigned sessions completed by each participant during the six-week course, from 0 to 18. Higher counts indicate greater attendance. |
| Other | Number of Exercise Classes Attended | From exercise-program baseline through exercise-program week 12 | Number of supervised RISE STRONG classes attended by each trial participant during the 12-week program, from 0 to 24. Higher counts indicate greater attendance. Attendance is recorded in session logs. |
| Other | Number of Participants With at Least One Adverse Event | From EVS-trial consent through exercise-program week 12 | Number of participants experiencing at least one adverse event during the defined surveillance period, reported by assigned group. Events are recorded with onset, severity, seriousness, relatedness to study procedures, action taken and outcome. |
| Other | Percentage of Participants Correctly Guessing Treatment Allocation | Exercise-program week 12, before allocation disclosure | Number of participants whose active-versus-sham allocation guess matches their assigned group divided by the number providing a guess, multiplied by 100, reported by assigned group. |
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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