protocolSection identificationModule nctId: NCT06269549, orgStudyIdInfo id: KDS_KOA, briefTitle: Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis, acronym: KDSKOA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Primorska, class: OTHER, collaborators name: Community Healthcare Center dr. Adolf Drolc Maribor (HCM), descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are:* Is adding a dietary supplement to exercise additionally effective in managing KOA?* Is adding exercise to the dietary supplement additionally effective in managing KOA?Participants will be given in three groups:1. Real dietary supplement alone2. Real dietary supplement with exercise3. Placebo dietary supplement with exerciseInvestigators will compare groups 1 and 2, or 2 and 3, to answer the research questions.The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Placebo blinding / masked for dietary supplement, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Non-training Real Dietary Supplement (G1), interventions name: Training Placebo Dietary Supplement (G2), interventions name: Training Real Dietary Supplement (G3), outcomesModule primaryOutcomes measure: Change from baseline in severity grading of knee osteoarthritis from X-ray Images at week 12, primaryOutcomes measure: Change from baseline in thickness of the articular cartilage and cross-section of muscles around knee joint at week 12, primaryOutcomes measure: Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12, primaryOutcomes measure: Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12, primaryOutcomes measure: Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12, primaryOutcomes measure: Change from baseline in knee pain on visual analogue scale at week 12, primaryOutcomes measure: Change from baseline in static balance time at week 12, primaryOutcomes measure: Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12, primaryOutcomes measure: Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12, primaryOutcomes measure: Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12, primaryOutcomes measure: Change from baseline in number of repetitions in Chair Stand Test at week 12, primaryOutcomes measure: Change from baseline in time for Five Times Sit to Stand Test at week 12, primaryOutcomes measure: Change from baseline in number of repetitions in Arm Curl Test at week 12, primaryOutcomes measure: Change from baseline in lower body flexibility at week 12, primaryOutcomes measure: Change from baseline in upper body flexibility at week 12, primaryOutcomes measure: Change from baseline in 6-minute walk distance at week 12, primaryOutcomes measure: Change from baseline in maximal isometric voluntary contraction of knee flexor and extensor at week 12, primaryOutcomes measure: Change from baseline in explosive strength of knee extensor at week 12, primaryOutcomes measure: Change from baseline in 24-hour time use at week 12, primaryOutcomes measure: Change from baseline in presence of inflammatory markers in blood sample at week 12, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Primorska, Faculty of Health Sciences, city: Izola, zip: 6310, country: Slovenia, contacts name: Nejc Šarabon, PhD, role: CONTACT, phone: 05 662 64 66, phoneExt: +386, email: nejc.sarabon@fvz.upr.si, contacts name: Tina Čeh, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 45.53694, lon: 13.66194, locations facility: Community Healthcare Center dr. Adolf Drolc, city: Maribor, zip: 2000, country: Slovenia, contacts name: Jernej Završnik, PhD, role: CONTACT, phone: 02 2286 257, phoneExt: +386, email: jernej.zavrsnik@zd-mb.si, contacts name: Tina Čeh, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 46.55472, lon: 15.64667, hasResults: False