protocolSection identificationModule nctId: NCT06324422, orgStudyIdInfo id: Fatigue & Parkinson's disease, briefTitle: Exercise as Treatment of Fatigue in Parkinson´s Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease (PD).The study will be a randomized multi-site controlled trial with follow up. Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle (control period).It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue (i.e., clinical relevant reductions) when compared to the PD control group (primary hypothesis), and that these effects are sustained after 12-weeks of follow up (secondary hypothesis)., conditionsModule conditions: Parkinson's Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled multi-site trial with follow-up, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise intervention, interventions name: Resistance exercise intervention, outcomesModule primaryOutcomes measure: Change in Modified Fatigue Impact Scale, secondaryOutcomes measure: Change in Fatigue Severity Scale, secondaryOutcomes measure: Change in Parkinson's Fatigue Scale, secondaryOutcomes measure: Change in Parkinson's Disease Questionnaire 39, secondaryOutcomes measure: Change in Baecke Habitual Physical Activity Questionnaire, secondaryOutcomes measure: Change in Pitchburg Sleep Quality Index, secondaryOutcomes measure: Change in Major Depression Inventory, secondaryOutcomes measure: Change in European Quality of life - 5 Dimensions, secondaryOutcomes measure: Change in Non-motor Symptoms Questionnaire, secondaryOutcomes measure: Change in Brief Pain Inventory (Short Form), secondaryOutcomes measure: Change in The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, secondaryOutcomes measure: Change in Six Minute Walk Test, secondaryOutcomes measure: Change in Timed Up and Go, secondaryOutcomes measure: Change in Six Spot Step Test, secondaryOutcomes measure: Change in Symbol Digit Modalities Test, secondaryOutcomes measure: Change in Montreal Cognitive Assessment, secondaryOutcomes measure: Change in Muscle strength, secondaryOutcomes measure: Change in aerobic capacity, secondaryOutcomes measure: Change in Physical activity, secondaryOutcomes measure: Change in Rochester Fatigue Diary, secondaryOutcomes measure: Change in Visual Analog Scale for fatigue, tremor, bradykinesia, rigidity and postural instability, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Exercise Biology, Dep. of Public Health, Aarhus University, city: Aarhus, state: Midtjylland, zip: 8000, country: Denmark, contacts name: Cecilie Thrue, PhD student, role: CONTACT, phone: 004520768102, email: ceth@ph.au.dk, contacts name: Cecilie Thrue, PhD student, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False