protocolSection identificationModule nctId: NCT06354985, orgStudyIdInfo id: 23-5996, secondaryIdInfos id: MODEX2023, type: OTHER, domain: Clinical Trial Protocol Number, secondaryIdInfos id: FRN:183960, type: OTHER_GRANT, domain: CIHR, secondaryIdInfos id: CTO Project ID: 4701, type: OTHER, domain: Clinical Trials Ontario, briefTitle: Modafinil and Exercise for Post Stroke Fatigue, acronym: MODEX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke.Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has two main aims:1. Test if Exercise Program One is better than Exercise Program Two2. Test if Modafinil is better than a Sugar PillAs another aim, the investigators will also look at if combining Modafinil with exercise has any benefits.This study will take place at 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels.Participants will be assigned at random (like flipping a coin) to 1 of 4 groups:1. Sugar Pill plus Exercise Program One2. Sugar Pill plus Exercise Program Two3. Modafinil plus Exercise Program One4. Modafinil plus Exercise Program TwoThe treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months.The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke., conditionsModule conditions: Stroke, conditions: Fatigue, conditions: Modafinil, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All members of the research team and the participants will be blinded to medication group allocation, but cannot be blinded to exercise group allocation. Evaluators and the study statistician will be blinded to the exercise group allocation. The study statistician and the rest of the Data Safety Monitoring Board will have access to the medication assignment if needed (e.g. adverse drug reaction)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: Modafinil 200mg, interventions name: Placebo, interventions name: Exercise Program One, interventions name: Exercise Program Two, outcomesModule primaryOutcomes measure: Severity of Fatigue Symptoms, secondaryOutcomes measure: Severity of Fatigue Symptoms, secondaryOutcomes measure: Impact on Quality of Life, secondaryOutcomes measure: Walking Recovery, secondaryOutcomes measure: Leg Strength and Coordination, secondaryOutcomes measure: 3-Day Physical Activity Assessment, secondaryOutcomes measure: Mood and Anxiety, secondaryOutcomes measure: Attention, secondaryOutcomes measure: Cognition, secondaryOutcomes measure: Health Resource Utilization, secondaryOutcomes measure: Quality Adjusted Life Years, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False