Refractory EpilepsyNCT04607317
Exercise as Adjunctive Treatment for Refractory Epilepsy
A study testing Exercise program, Health Coach and Health Information in people with Refractory Epilepsy and Epilepsy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy. The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Epilepsy, Epilepsy
- What is being tested?
- Exercise program, Health Coach and Health Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Focal or generalized epilepsy, as clinically determined by a Wake Forest Baptist Health epileptologist.
- Seizure frequency of at least 1 clinically observable seizure in the year prior to enrollment
- Able to ambulate independently without assistive device
- Access to a smartphone with application capabilities
- Internet access or cellular data plan to attend virtual sessions
Who cannot join
- Diagnosis of nonepileptic or psychogenic spells
- Seizures associated with frequent falls with injury
- <50% adherence with wearing the device or completing the study diary during the baseline period.
- Currently in an exercise program
- Medical conditions that would limit ability to participate in an exercise intervention such as:
- Stage III or IV Congestive Heart Failure (CHF)
Show all 10Show fewer
- End-stage Renal Disease
- Severe dementia or significant cognitive impairment
- Uncontrolled hypertension (HTN)
- Motor conditions that limit ambulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Telehealth Physical Exercise Intervention for the Treatment of Drug Resistant Epilepsy
The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy.
The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.
Read the detailed description
This is a randomized, controlled pilot trial to assess the feasibility and fidelity of a 12 week, individualized, telehealth exercise intervention in people with refractory epilepsy. This will be carried out using a 2 arm, parallel group design with a waitlist attention control.
Participants will undergo formal exercise testing prior to enrollment to determine safety and establish a baseline fitness level. Participants will use a wrist-worn Garmin device to record activity and sleep. After a 4 week baseline period, participants will be randomized to intervention or wait-list attention control. The intervention group will undergo a 12-week telehealth exercise program designed by a trained health coach and tailored to the individual's personal fitness level and exercise preferences. The intervention is based in social cognitive theory to implement and enforce sustainable behavior change. The wait-list attention control will receive health education but will not be given an exercise program. At the end of the intervention period, the control group will be given the option to participate in the exercise program.
The study will assess recruitment and retention as well as fidelity, acceptability and sustainability of a telehealth exercise intervention in this population.
The study will investigate objective and subjective measures of the effect of the intervention on the known seizure triggers of sleep and stress as possible mediators of seizure frequency.
The study will collect information regarding the effects of the intervention on depression, anxiety, quality of life, cognition, and seizure frequency.
- Conditions
- Refractory Epilepsy, Epilepsy
- Being tested
- Exercise program, Health Coach, Health Information
- Keywords
- exercise, telehealth, adjunctive treatment
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programBehavioural
a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day)
Health CoachBehavioural
The coach will work directly with each participant during their once-weekly virtual 1:1 meeting to progress intensity and duration. Participants will meet with the coach to review a brief social cognitive theory-based module, which will provide education on core behavior change concepts and the benefits of physical activity for those with epilepsy. The coach will review the previous week's exercise during meetings, and will then work with the participant to revise and reset goals for the coming week.
Health InformationBehavioural
Participants will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Participants in this arm will be enrolled in a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day). Participants will meet weekly 1:1 with a trained health coach via a Webex platform. Weekly exercise goals will be tailored to the individual's abilities and specific barriers. Coaching will utilize social cognitive theory and self-determination theory to develop self-efficacy for sustainable behavior change. Receives: Behavioral: Exercise program; Behavioral: Health Coach |
| Control | Active comparator | Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks. They will continue to wear the Garmin activity tracker and can view their activity but will not be given an exercise program. They will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene. Receives: Behavioral: Health Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants recruited
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.
Measured: Week 0 Baseline
Proportion of participants completing all visits
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.
Measured: Visit 3 (Week 16 after Baseline)
Secondary outcomes (3)
Proportion of Participants who achieve their target
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
Measured: Visit 3 (Week 16 after Baseline)
Acceptability of the Intervention Questionnaire
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.
Measured: Week 16 and Week 28 after baseline
Percentage of participants achieving the goal for at least 10 weeks
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.
Measured: Week 28 after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start13 Apr 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Why it stopped: did not enroll as many as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to exercise intervention arm or control arm.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Halley Alexander, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607317
- Sponsor's protocol ID
- IRB00068408
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Physical Exercise Intervention for the Treatment of Drug Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT04607317
- Acronym / sponsor ID
- IRB00068408
- Conditions
- Refractory Epilepsy, Epilepsy
- Keywords
- exercise, telehealth, adjunctive treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: did not enroll as many as planned
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy.
The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.
Detailed description
This is a randomized, controlled pilot trial to assess the feasibility and fidelity of a 12 week, individualized, telehealth exercise intervention in people with refractory epilepsy. This will be carried out using a 2 arm, parallel group design with a waitlist attention control.
Participants will undergo formal exercise testing prior to enrollment to determine safety and establish a baseline fitness level. Participants will use a wrist-worn Garmin device to record activity and sleep. After a 4 week baseline period, participants will be randomized to intervention or wait-list attention control. The intervention group will undergo a 12-week telehealth exercise program designed by a trained health coach and tailored to the individual's personal fitness level and exercise preferences. The intervention is based in social cognitive theory to implement and enforce sustainable behavior change. The wait-list attention control will receive health education but will not be given an exercise program. At the end of the intervention period, the control group will be given the option to participate in the exercise program.
The study will assess recruitment and retention as well as fidelity, acceptability and sustainability of a telehealth exercise intervention in this population.
The study will investigate objective and subjective measures of the effect of the intervention on the known seizure triggers of sleep and stress as possible mediators of seizure frequency.
The study will collect information regarding the effects of the intervention on depression, anxiety, quality of life, cognition, and seizure frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to exercise intervention arm or control arm.
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise program, Behavioral: Health CoachParticipants in this arm will be enrolled in a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day). Participants will meet weekly 1:1 with a trained health coach via a Webex platform. Weekly exercise goals will be tailored to the individual's abilities and specific barriers. Coaching will utilize social cognitive theory and self-determination theory to develop self-efficacy for sustainable behavior change. |
| Control | Active comparator | Behavioral: Health InformationParticipants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks. They will continue to wear the Garmin activity tracker and can view their activity but will not be given an exercise program. They will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Focal or generalized epilepsy, as clinically determined by a Wake Forest Baptist Health epileptologist.
- Seizure frequency of at least 1 clinically observable seizure in the year prior to enrollment
- Able to ambulate independently without assistive device
- Access to a smartphone with application capabilities
Key exclusion criteria (10 listed)
- Diagnosis of nonepileptic or psychogenic spells
- Seizures associated with frequent falls with injury
- <50% adherence with wearing the device or completing the study diary during the baseline period.
- Currently in an exercise program
- Medical conditions that would limit ability to participate in an exercise intervention such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programa telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day) | Behavioural | Exercise Intervention |
| Health CoachThe coach will work directly with each participant during their once-weekly virtual 1:1 meeting to progress intensity and duration. Participants will meet with the coach to review a brief social cognitive theory-based module, which will provide education on core behavior change concepts and the benefits of physical activity for those with epilepsy. The coach will review the previous week's exercise during meetings, and will then work with the participant to revise and reset goals for the coming week. | Behavioural | Exercise Intervention |
| Health InformationParticipants will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene. | Behavioural | Control |
Primary outcome
Proportion of participants recruited
Time frame: 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.
Proportion of participants completing all visits
Time frame: 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.
3 secondary outcomes
Proportion of Participants who achieve their target
Time frame: Visit 3 (Week 16 after Baseline)
Acceptability of the Intervention Questionnaire
Time frame: Week 16 and Week 28 after baseline
Percentage of participants achieving the goal for at least 10 weeks
Time frame: Week 28 after baseline
Results and safety
The study was stopped early (reason given: did not enroll as many as planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halley Alexander, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program, Health Coach and Health Information in people with Refractory Epilepsy and Epilepsy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: did not enroll as many as planned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants recruited (time frame: Week 0 Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.