12-week physical activity program for Aura

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atrium Health Wake Forest Baptist, Winston-Salem, NC
Aura
12-week physical activity program - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this research study is to evaluate the feasibility of a 12-week, telehealth delivered, step-goal based physical activity intervention in people with epilepsy. The study team will also evaluate the physical activity profiles of people with epilepsy both at rest and when engaged in physical activity and gather information on the effect of the intervention on epilepsy and epilepsy associated comorbidities.

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Week 4, Week 16, and Week 28

Week 14
Proportion of participants who achieve their assigned step goal - adherence
Week 16
Exercise Satisfaction Survey- Proportion of participants with a 4 or higher response
Week 28
Proportion of participants who achieve their assigned step goal- sustainability
Week 28
Exit survey
Week 28
Time spent in light intensity activity
Time spent in moderate intensity activity
Time spent in vigorous intensity activity
Time spent sedentary

Trial Safety

Trial Design

2 Treatment Groups

Arm 2 Control
1 of 2
Arm 1: Exercise Intervention
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: 12-week physical activity program · No Placebo Group · N/A

Arm 1: Exercise Intervention
Behavioral
Experimental Group · 1 Intervention: 12-week physical activity program · Intervention Types: Behavioral
Arm 2 ControlNoIntervention Group · 1 Intervention: Arm 2 Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 4, week 16, and week 28
Closest Location: Atrium Health Wake Forest Baptist · Winston-Salem, NC
N/AFirst Recorded Clinical Trial
0 TrialsResearching Aura
0 CompletedClinical Trials

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,100 Previous Clinical Trials
1,128,995 Total Patients Enrolled
Halley Alexander, MDPrincipal InvestigatorWake Forest Health Sciences
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.