Trial · NCT04607317
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants recruited | Week 0 Baseline | This outcome measure assesses Feasibility of Recruitment. Recruitment will be calculated as a percentage by dividing the total number of enrolled participants by the total number of eligible participants. |
| Primary | Proportion of participants completing all visits | Visit 3 (Week 16 after Baseline) | This outcome measure assesses Feasibility of Retention. Retention will be calculated as the percentage of all participants who complete Visit 2 Week 16 (End of Intervention) out of the total number of participants enrolled. |
| Secondary | Proportion of Participants who achieve their target | Visit 3 (Week 16 after Baseline) | Fidelity of the Intervention is the proportion of participants in the intervention group who achieve their target HR for at least 80% of their individually prescribed weekly minutes. A priori goal 70% of participants achieve this in at least 10 out of the 12 weeks of the intervention |
| Secondary | Acceptability of the Intervention Questionnaire | Week 16 and Week 28 after baseline | This will be a qualitative measure based on post program question of how satisfied the subject was with the exercise intervention with a scale of 1=Very Unsatisfied, 2=Unsatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied. Results will include percentage of people who answer 4 or above. |
| Secondary | Percentage of participants achieving the goal for at least 10 weeks | Week 28 after baseline | Sustainability of the intervention is defined as maintenance of at least 80% of the last assigned weekly minutes in target HR zone each week. The intervention will be considered sustainable if 60% of the participants achieve this goal for at least 10 out of the 12 follow-up weeks. |
| Other | Heart Rate Variability (HRV) measurement | baseline and Visit 3 (week 16 after baseline) | Continuous heart rate will be recorded while the participant is breathing normally in seated position for 10 minutes. This will be assessed by sympathetic and parasympathetic activity expressed as low-frequency (LF) and high-frequency (HF) power spectrum, standard deviation of NN intervals (SDNN), and the root mean square of successive differences (RMSSD). |
| Other | Perceived Stress Scale (PSS) | baseline, week 16 after baseline, week 28 after baseline | A validated measure of the subjective stress experience which has been shown to correlate with systemic stress hormones. Individual scores can range from 0 to 40 with higher score indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. |
| Other | Pittsburgh Sleep Quality Index (PSQI) | baseline, week 16 after baseline, week 28 after baseline | Scores range from 0-21 with higher score indicating worse sleep quality. A common cutoff for poor sleep quality is score greater than 5. |
| Other | Nightly average total sleep time (TST) | baseline, week 16 after baseline, week 28 after baseline | will be collected from the wearable device |
| Other | Change in Seizure Frequency | baseline, week 16 after baseline, week 28 after baseline | the number of seizures during the final 4 weeks of the intervention will be compared to the number of seizures during the 4 week baseline. |
| Other | Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) | baseline, Visit 3 (week 16 after baseline) | Scores range from 6-24 with higher scores indicating higher risk for depression. A common cutoff is that a score greater than 15 is suggestive of major depression. |
| Other | Generalized Anxiety Disorder (GAD-7) | baseline, week 16 after baseline, week 28 after baseline | Scores range from 0-21. A score of 10 or greater suggests high risk for Generalized Anxiety Disorder (GAD), while scores of 5-9, 10-14, and 15-21 could represent mild, moderate, and severe GAD. |
| Other | Test of Premorbid Functioning (TOPF) | baseline | TOPF is a test of static cognitive function. This is a standard score with a mean of 100 and a standard deviation of 15. The score can range from \~60-145. This is a single word reading test that is used to estimate premorbid functioning. A higher score denotes a better outcome. |
| Other | Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV) | baseline and week 16 after baseline | Digit Span Subtest. A common measure of current overall intellectual functioning. This scale produces a standard score with a mean of 100 and a standard deviation of 15. A higher score is better. |
| Other | Controlled Oral Word Association Test (COWAT) | baseline and week 16 after baseline | This test produces a T score with a mean of 50 and an standard deviation of 10. It measures lexical and semantic verbal fluency. |
| Other | Rey Auditory Verbal Learning Test (RAVLT) | baseline and week 16 after baseline | This test produces a T score with a mean of 50 and a standard deviation of 10. It measures verbal learning and memory. |
| Other | Delis-Kaplan Executive Function Stroop Test | baseline and week 16 after baseline | This test produces a scaled score of 10 with a standard deviation of 3. It measures cognitive inhibition. |
| Other | Physical Function: walk test | baseline and week 16 after baseline | Measure of cardiorespiratory fitness. Distance walked in 6 minutes. |
| Other | Quality of Life in Epilepsy-31 (QOLIE-31) | baseline, week 16 after baseline, week 28 after baseline | Score ranges from 0-100 with higher score indicating better quality of life. |
| Other | Exercise Self-Efficacy Questionnaire (EXSE) | baseline, week 16 after baseline, week 28 after baseline | Items on all self-efficacy questionnaire that ask participants to rate their confidence on a 100-point percentage scale such that 0% corresponds with "not confident at all", and 100% corresponds with "highly confident", and scale scores are generated by averaging all items in the scale. Higher scores represent greater self-efficacy. |
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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