Kinesiological and dietary supplement intervention for knee osteoarthritis
Effectiveness of Kinesiological and Dietary Supplement Intervention in Individuals With Knee Osteoarthritis
This study is testing if a combination of a dietary supplement and exercise can help people with knee osteoarthritis feel less pain and improve their daily activities compared to just one of those treatments or a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Primorska Academic / other |
| Locations | 2 sites (Izola and 1 other locations) |
| Trial ID | NCT06269549 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a dietary supplement combined with exercise in managing knee osteoarthritis (KOA). Participants will be randomly assigned to one of three groups: receiving a real dietary supplement alone, a real dietary supplement with exercise, or a placebo dietary supplement with exercise. The study will assess pain levels, physical function, and quality of life before and after a 12-week intervention, followed by a 6-week follow-up. The goal is to determine if the combination of dietary supplements and exercise provides greater benefits than either intervention alone.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older with knee osteoarthritis of grades 1-3 and moderate pain levels.
Not a fit: Patients with severe knee osteoarthritis (grade 4), acute knee injuries, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce pain and improve physical function and quality of life for patients with knee osteoarthritis.
How similar studies have performed: Other studies have shown promising results with similar dietary and exercise interventions for managing osteoarthritis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * knee osteoarthritis of one or both knee * severity of knee osteoarthritis based on Kellgren-Lawrence radiographic grade 1-3 * knee pain between 4 and 7 (using a 0-10 scale) Exclusion Criteria: * Age \<55 years * Kellgren \& Lawrence grade 4 of knee osteoarthritis * Acute knee injuries within the last 6 months * Knee pain not associated with knee osteoarthritis * History of knee or hip endoprosthesis * Surgery on the back, hip, knee, ankle, or foot within the last 12 months * Health issues or musculoskeletal limitations affecting strength training and mobility more than knee pain (e.g., lower back pain, hip pain) * Rheumatoid arthritis, gout * Neurological conditions (Alzheimer's disease, Parkinson's disease, metabolic diseases affecting the nervous system) * Muscular or joint diseases/injuries affecting lower limb function (e.g., hip and/or ankle osteoarthritis, sprains, fractures) * Internal medical conditions (cardiovascular, pulmonary, oncological, diabetes with late complications - diabetic foot, neuropathies) affecting physical performance * Stroke or similar condition with consequences on motor skills and/or cognition (inability to provide consent) * Balance disorders, known vestibular system impairment * Body Mass Index \> 32 * Structured strength training exceeding 30 minutes per week * Corticosteroids and/or hyaluronic acid (intra-articular) use in the last 6 months * Individuals taking joint health dietary supplements, like glucosamine, chondroitin, or collagen, will need to halt use for at least 30 days before measurements to avoid affecting study outcomes
Where this trial is running
Izola and 1 other locations
- University of Primorska, Faculty of Health Sciences — Izola, Slovenia (Recruiting)
- Community Healthcare Center dr. Adolf Drolc — Maribor, Slovenia (Recruiting)
Study contacts
- Study coordinator: Nejc Šarabon, PhD
- Email: nejc.sarabon@fvz.upr.si
- Phone: 05 662 64 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.