MODEX
Summary
Post stroke fatigue afflicts as many as 70% of the 400,000 Canadians with stroke. There are no treatments for post stroke fatigue supported by research studies, however, exercise and the medication Modafinil have shown promise in alleviating symptoms in small studies. For this study we are looking at combining Modafinil with an instructor-led, home-based exercise program based on the “Fitness and Mobility Exercise (FAME)” program to help improve fatigue symptoms after stroke. A home-based exercise program delivered by videoconference allows participants to join exercise sessions over video from their homes, without having to travel to a different location.
The purpose of this study is to:
- Test whether Modafinil and exercise can improve the symptoms of post-stroke fatigue
- Investigate the effects of Modafinil and exercise on other areas including but not limited to quality of life, fitness, mood, and health care utilization.
Eligibility
Eligible ages: 18 to 100
Inclusion criteria:
Inclusion Criteria
1. ≥18 years of age (on date of consent)
2. >3 months post stroke onset (i.e., intracerebral hemorrhage or ischemic stroke diagnosed by a physician) (on date of consent)
3. evidence of stroke on computed tomography (CT) or magnetic resonance imaging (MRI) or confirmed by a physician
4. disabling post stroke fatigue as measured by Multidimensional Fatigue Inventory score >60
5. Modified Rankin disability score ≤ 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
6. Able to participate in moderate exercise for an hour (with one person assistance or less)
Exclusion criteria:
Exclusion Criteria
1. known contraindications to Modafinil: cyclosporine, clomipramine, monoamine oxidase (MAO) inhibitors
2. on central nervous system (CNS) stimulant medications already (such as dextroamphetamine, methylphenidate, and amphetamines)
3. subarachnoid hemorrhage
4. impaired comprehension or language impairment that prevents following visual or pictograph adapted instructions or providing informed consent
5. severe motor impairment or inability to participate in the exercise
6. unable to participate in exercise due to musculoskeletal complaints, unstable heart failure, or renal disease
7. untreated hypothyroidism or anemia
8. cancer likely to result in death in <6 months
9. severe depression requiring therapy as indicated by suicidal ideation and/or DASS depression sub-score >20
10. currently enrolled in a structured exercise program
11. untreated severe sleep apnea with an Apnea/Hypopnea index >30 as measured by validated wearable sleep apnea detector
12. pregnant, breastfeeding, or positive test for pregnancy at baseline
13. unable to understand English or communicate with the study team
14. unwilling or unable to comply with trial requirements
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
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Additional information
Contact information
Study Coordinator Elaine Nguyen: elaine.nguyen@ucalgary.ca
Principal investigator:
Sean Dukelow
Clinical trial:
Yes
REB-ID:
REB25-0413
External links