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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05359003




Registration number
NCT05359003
Ethics application status
Date submitted
28/04/2022
Date registered
3/05/2022

Titles & IDs
Public title
Steps for Epilepsy
Scientific title
A Feasibility Study of a Step-goal Based Physical Activity Intervention in People With Epilepsy
Secondary ID [1] 0 0
IRB00084252
Universal Trial Number (UTN)
Trial acronym
StEpi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - 12-week physical activity program

Experimental: Arm 1: Exercise Intervention - Participants in this arm will undergo a 12-week physical activity program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps).

No intervention: Arm 2 Control - Participants randomized to the wait-list attention control group will continue to undergo standard care for 12 weeks.


BEHAVIORAL: 12-week physical activity program
Program aimed to achieve the equivalent of 8,000 steps per day (56,000 weekly steps). Includes weekly meetings with a trained health coach.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants who achieve their assigned step goal - adherence
Timepoint [1] 0 0
Week 12 to Week 14
Primary outcome [2] 0 0
Proportion of participants who achieve their assigned step goal- sustainability
Timepoint [2] 0 0
Week 24 to Week 28
Secondary outcome [1] 0 0
Time spent sedentary
Timepoint [1] 0 0
Week 4, Week 16, and Week 28
Secondary outcome [2] 0 0
Time spent in light intensity activity
Timepoint [2] 0 0
Week 4, Week 16, and Week 28
Secondary outcome [3] 0 0
Time spent in moderate intensity activity
Timepoint [3] 0 0
Week 4, Week 16, and Week 28
Secondary outcome [4] 0 0
Time spent in vigorous intensity activity
Timepoint [4] 0 0
Week 4, Week 16, and Week 28
Secondary outcome [5] 0 0
Exit survey
Timepoint [5] 0 0
Week 28
Secondary outcome [6] 0 0
Exercise Satisfaction Survey- Proportion of participants with a 4 or higher response
Timepoint [6] 0 0
Week 16

Eligibility
Key inclusion criteria
* Age 18 or older
* Focal or generalized epilepsy, as determined clinically by a WFBH epileptologist with no significant consideration of an alternative diagnosis
* Access to a smartphone with application capabilities
* Internet access or cellular data plan to attend virtual sessions
* Able to ambulate independently
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of nonepileptic or psychogenic spells
* Seizures associated with falls with injury (such as atonic seizures)
* Medical conditions that would limit ability to participate in an exercise intervention including:

Stage III or IV Congestive Heart Failure (CHF) End-stage Renal Disease Severe dementia or significant cognitive impairment that precludes participation in the intervention or limits ability to follow the study protocol Uncontrolled hypertension (HTN) defined as systolic blood pressure greater than 180 mmHg and diastolic blood pressure greater than 110 mmHg at rest Severe arthritis, amputations, or orthopedic problems that limit ambulatory ability

* Currently pregnant or plan to become pregnant during the study period (16 weeks)
* An active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurologic disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
* Any clinically significant psychiatric illness, psychological, or behavioral problems that would interfere with the subject's ability to participate in the study.
* Unwilling or unable to comply with all study visits and procedures
* Participants who have <75% complete days of seizure recording in the study diary or step data via the Garmin device will not be randomized.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
Wake Forest University Health Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Halley Alexander, MD
Address 0 0
Wake Forest Health Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05359003