Trial · NCT04607317
Exercise as Adjunctive Treatment for Refractory Epilepsy
NCT04607317, Not applicable, Terminated, Wake Forest University Health Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exercise as Adjunctive Treatment for Refractory Epilepsy. Trials, record NCT04607317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04607317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exercise as Adjunctive Treatment for Refractory Epilepsy
- NCT number
- NCT04607317
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 10 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Refractory Epilepsy, Epilepsy
- Interventions
- Exercise program, Health Coach, Health Information
- First posted
- 2020-10-29
- Last updated
- 2022-12-07
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
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 |
|---|---|---|
| Digit Span Test | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
| Verbal Learning | Other outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04607317
GET https://conductscience.org/api/trials/v1/NCT04607317/registered?page=2