protocolSection identificationModule nctId: NCT06277401, orgStudyIdInfo id: RCT_hypermobile_knee, briefTitle: Exercise in Patients With Hypermobile Joints and Knee Pain, acronym: HIPEr-Knee, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, collaborators name: Independent Research Fund Denmark, collaborators name: Odense Patient Data Explorative Network, descriptionModule briefSummary: Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain., conditionsModule conditions: Hypermobility, Joint, conditions: Hypermobility Syndrome, conditions: Knee Discomfort, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The patients will be kept blind to treatment allocation by being provided with minimal information about the content of the two exercise interventions and the study hypotheses; the patients will be informed that the study compares two different exercise protocols that both include safe exercises to reduce knee pain and increase knee function.An independent biostatistician blinded to group allocation will perform the primary RCT analysis. To reduce the risk of interpretation bias, blinded results from the analyses (group A compared with group B) will be presented to all authors, who will agree on two alternative written interpretations before the data manager unblinds the randomisation code., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Neuromuscular training for the knee, interventions name: High-load strength training for the knee, outcomesModule primaryOutcomes measure: Visual Analogue Scale Nominated Activity, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Dynamic knee strength, secondaryOutcomes measure: Knee reposition sense, secondaryOutcomes measure: Single-Leg-Hop for Distance, otherOutcomes measure: Knee pain past week, otherOutcomes measure: Tampa scale of Kinesiophobia (TSK) 11 item, otherOutcomes measure: EQ-5D-5L, otherOutcomes measure: EQ VAS, otherOutcomes measure: Global perceived effect (GPE), otherOutcomes measure: PASS, otherOutcomes measure: TF, otherOutcomes measure: Clinical important difference, otherOutcomes measure: Knee instability questions, otherOutcomes measure: Tendon stiffness, otherOutcomes measure: Quadriceps rate of torque development (RTD), otherOutcomes measure: Patella instability, otherOutcomes measure: Quadriceps maximal voluntary isometric contraction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Physiotherapy Clinics Region of Southern Denmark, city: Odense, state: Fyn, zip: 5000, country: Denmark, contacts name: Behnam Liaghat, PhD, role: CONTACT, phone: +4526826801, email: bliaghat@health.sdu.dk, geoPoint lat: 55.39594, lon: 10.38831, locations facility: University of Southern Denmark, city: Odense, state: Fyn, zip: 5230, country: Denmark, contacts name: Behnam Liaghat, PhD, role: CONTACT, phone: +4526826801, email: bliaghat@health.sdu.dk, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False