Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis

NCT06269549 | Active Not Recruiting

• 1 other identifier: KDS_KOA
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief 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:
• Real dietary supplement alone
• Real dietary supplement with exercise
• Placebo dietary supplement with exercise

Conditions

Osteoarthritis, Knee

Keywords

exercise; physical activity; dietary supplement

Outcome Measures

Primary Outcomes (15)

• Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 and at a 6-week follow-up

  WOMAC is a self-assessment questionnaire consisting of 24 questions, addressing pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A higher achieved value or sum of points (0-96) indicates a worse condition.

  Baseline, week 12 and at a 6-week follow-up

• Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12

  SF-36 is a self-assessment questionnaire on quality of life consisting of 36 items, which are grouped into domains measuring eight health components: physical functioning, role limitations due to physical health, role limitations due to emotional health, vitality, mental health, social functioning, bodily pain, and general health. Each item is scored, and each health component provides a score ranging from 0 to 100, where a score of 0 indicates very poor health, while a score of 100 indicates excellent health.

  Baseline and week 12

• Change from baseline in knee pain on numeric rating scale at week 12

  Numeric rating scale (NRS) measures pain intensity. It is subjectively assess the current level of knee pain on a scale from 0 (no pain) to 10 (worst possible pain). Change = week 12 score - baseline score

  Baseline and week 12

• Change from baseline in 40 metre fast-paced walk at week 12 and at a 6-week follow-up

  A timed walk of 4 x 10 metres for a total of 40 metres

  Baseline, week 12 and at a 6-week follow-up

• Change from baseline in static balance time at week 12

  A piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, allowing us to record the movement of the center of pressure on the surface over time. The position is a single-leg stance, with the test conducted with eyes open, and parallel stance with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate time of single-leg stance and parallel stance.

  Baseline and week 12

• Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12

  The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific amplitude from the center of pressure on the surface.

  Baseline and week 12

• Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12

  The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific velocity from the center of pressure on the surface.

  Baseline and week 12

• Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12

  The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific frequency from the center of pressure on the surface.

  Baseline and week 12

• Change from baseline in number of repetitions in Chair Stand Test at week 12 and at a 6-week follow-up

  Chair Stand Test is measure lower body strength, in which participants stand up repeatedly from a chair for 30 seconds with their arms across their chest. Investigators will measure the number of repetitions in one set.

  Baseline, 12 week and at a 6-week follow-up

• Change from baseline in time for Five Times Sit to Stand Test at week 12

  The Five Times Sit to Stand Test scoring is based on the amount of time (to the nearest decimal in seconds) a participant is able to transfer from a seated to a standing position and back to sitting five times with their arms across their chest. Test is used to asses functional lower limbs strength, balance, and fall risk.

  Baseline, 12 week and at a 6-week follow-up

• Change from baseline in lower body flexibility at week 12

  The participant sits on the edge of a chair. One foot must remain flat on the floor, while the other leg is extended forward with the knee straight, heel on the floor, and ankle bent at a 90° angle. One hand is placed on top of the other, with the middle fingers aligned. The participant reaches forward towards the toes by bending at the hips. The back remains straight. The final position is held for 2 seconds. Investigators measure the distance between the fingertips and the toes. Two trials are performed, and the better result is considered.

  Baseline and 12 week

• Change from baseline in Timed up-and-go test (TUG) at week 12 and at a 6-week follow-up

  Timed up-and-go test measures functional mobility and balance. Participants will start seated in a chair with armrests. Upon the investigator's signal, participants will rise from the chair, walk 3 meters forward, turn around, walk back to the chair, and sit down. The time taken to complete the task will be recorded to the nearest tenth of a second. The test will be performed three times, and the best time will be recorded for analysis.

  Baseline, week 12 and at 6-week follow-up

• Change from baseline in 10-Step Stair Climb Test (SCT) at week 12 and at a 6-week follow-up

  After the practice trial, participants will perform one test trial, during which they will be instructed to ascend and descend a flight of 10 stairs as quickly as possible while maintaining safety. The time taken to complete the task will be recorded to the nearest tenth of a second.

  Baseline, week 12 and at 6-week follow-up

• Change from baseline in 6-minute walk distance at week 12

  6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome.

  Baseline and 12 week

• Change from baseline in maximal isometric voluntary contraction of knee flexors and extensors at week 12

  Maximal isometric voluntary contraction of knee flexion and extension will be performed using a knee dynamometer (S2P, Science in Practice, Ltd., Ljubljana, Slovenia), which will allow knee flexion and extension under static conditions with a knee joint angle of 60° and hip flexion in a seated position at 90°. A support will be placed over the ankle (2-3 cm above the lateral malleolus), through which the participant will press against the measuring part of the device. Before the measurement, the participant will perform two repetitions of flexion and extension with submaximal force, aimed at warming up the participant and familiarizing them with the test requirements. This will be followed by 3 muscle contractions with a 3-second hold at the maximum force produced, during which the participant will be verbally encouraged to achieve maximum strength.

  Baseline and week 12

Secondary Outcomes (6)

• Change from baseline in presence of inflammatory markers in blood sample at week 12

  Baseline and week 12

• Change from baseline in 24-hour time use at week 12

  Baseline and 12 week

• Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12

  Baseline and week 12

• Change from baseline in handgrip strength at week 12

  Baseline and week 12

• Change from baseline in number of repetitions in Arm Curl Test at week 12

  Baseline and 12 week

Study Arms (2)

The effect of dietary supplements added to physical exercise intervention

OTHER

This study arm will include two groups of participants, one receiving 12 weeks physical exercise intervention together with real dietary supplements (glucosamne and collagen), while the other group receiving exercise intervention with placebo dietary supplements (placebo glucosamine and collagen).

Other: Training Placebo Dietary Supplement (G2); Other: Training Real Dietary Supplement (G3)

The effect of physical exercise added to dietary supplement intervention

OTHER

This study arm will include two groups of participants, one receiving 12 weeks real dietary supplements alone (glucosamine and collagen), while the other group receiving real dietary supplements (glucosamine and collagen) with physical exercise.

Other: Non-training Real Dietary Supplement (G1); Other: Training Real Dietary Supplement (G3)

Interventions

Non-training Real Dietary Supplement (G1) OTHER

One capsule of glucosamine three times daily, and one packet of hydrolyzed collagen.

The effect of physical exercise added to dietary supplement intervention

Training Placebo Dietary Supplement (G2) OTHER

One capsule of placebo glucosamine three times daily, and one packet containing placebo collagen + physical exercise (60 minutes per session twice a week)

The effect of dietary supplements added to physical exercise intervention

Training Real Dietary Supplement (G3) OTHER

One capsule of glucosamine three times daily, and one packet of hydrolyzed collagen + physical exercise (60 minutes per session twice a week)

The effect of dietary supplements added to physical exercise intervention; The effect of physical exercise added to dietary supplement intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Primorska: lead
• Community Healthcare Center dr. Adolf Drolc Maribor (HCM): collaborator

Study Sites (2)

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

Community Healthcare Center dr. Adolf Drolc

Maribor, 2000, Slovenia

Location

Related Publications (2)

• Ceh T, Zavrsnik J, Sarabon N. Complementary effect of a combined exercise and dietary supplement intervention in individuals with knee osteoarthritis: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2026 Mar 3. doi: 10.1186/s13063-026-09594-7. Online ahead of print.

  PMID: 41772729 DERIVED

• Ceh T, Zavrsnik J, Sarabon N, Prosen M. Experiences and perceptions of a 12-week combined exercise and dietary supplement program for individuals with knee osteoarthritis: a qualitative focus group study. BMC Musculoskelet Disord. 2026 Jan 20;27(1):145. doi: 10.1186/s12891-026-09509-2.

  PMID: 41559644 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Nejc Šarabon, PhD

  University of Primorska, Faculty of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo blinding / masked for dietary supplement
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time)

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)