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Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis - Trial NCT06269549

Access comprehensive clinical trial information for NCT06269549 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Primorska and is currently Not yet recruiting. The study focuses on Osteoarthritis, Knee. Target enrollment is 120 participants.

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NCT06269549
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Trial Details
ClinicalTrials.gov โ€ข NCT06269549
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Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis
Effectiveness of Kinesiological and Dietary Supplement Intervention in Individuals With Knee Osteoarthritis

Study Focus

Osteoarthritis, Knee

Non-training Real Dietary Supplement (G1)

Interventional

other

Sponsor & Location

University of Primorska

Izola,Maribor, Slovenia

Timeline & Enrollment

N/A

Mar 01, 2024

Dec 31, 2025

120 participants

Primary Outcome

Change from baseline in severity grading of knee osteoarthritis from X-ray Images at week 12,Change from baseline in thickness of the articular cartilage and cross-section of muscles around knee joint at week 12,Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12,Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12,Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12,Change from baseline in knee pain on visual analogue scale at week 12,Change from baseline in static balance time at week 12,Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12,Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12,Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12,Change from baseline in number of repetitions in Chair Stand Test at week 12,Change from baseline in time for Five Times Sit to Stand Test at week 12,Change from baseline in number of repetitions in Arm Curl Test at week 12,Change from baseline in lower body flexibility at week 12,Change from baseline in upper body flexibility at week 12,Change from baseline in 6-minute walk distance at week 12,Change from baseline in maximal isometric voluntary contraction of knee flexor and extensor at week 12,Change from baseline in explosive strength of knee extensor at week 12,Change from baseline in 24-hour time use at week 12,Change from baseline in presence of inflammatory markers in blood sample at week 12

Summary

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 alone
 
 2. Real dietary supplement with exercise
 
 3. Placebo dietary supplement with exercise
 
 Investigators 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.

ICD-10 Classifications

Chronic instability of knee
Injuries to the knee and lower leg
Gonarthrosis [arthrosis of knee]
Dislocation, sprain and strain of joints and ligaments of knee
Sprain and strain of other and unspecified parts of knee

Data Source

ClinicalTrials.gov

NCT06269549

Non-Device Trial