Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

— KDSKOA  

Official title:

Effectiveness of Kinesiological and Dietary Supplement Intervention in Individuals With Knee Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269549
• Other study ID #: KDS_KOA
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Primorska
• Contact: Nejc Šarabon, PhD
• Phone: 05 662 64 66
• Email: nejc.sarabon[@]fvz.upr.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participant recruitment will take place at the Community Healthcare Center dr. Adolf Drolc Maribor based on the doctor's recommendation. Following an informed discussion about the study and potential risks, all patients providing written consent will undergo a one-week screening period to determine eligibility for study entry. Upon reaching week 0, patients meeting the eligibility criteria will be randomly assigned in a 1:1:1 ratio to receive either dietary supplements alone, dietary supplements combined with exercise, or placebo dietary supplement combined with exercise.

The effects of the kinesiological / dietary supplement intervention on selected measures will be assessed using a test battery, before and after the 12 week intervention.

Exercise / test batery will be conducted at Community Healthcare Center dr. Adolf Drolc under the supervision of an experienced kinesiologist / investigator.

Based on the posed research questions and hypotheses, investigators would like to highlight the following planned statistical analyses. In the case of bilateral KOA, investigators will analyze the more affected knee for differences between groups. In addition to descriptive statistics, investigators will assess normal distribution and homogeneity of variances. Differences between groups will be tested using two-way repeated measures analysis of variance (factor 1 = group, factor 2 = time) and paired two-tailed post-hoc t-tests with Bonferroni correction. The main comparison will be addressed with a 3x2 two-way analysis of variance. The first research question will be addressed with a 2x2 two-way analysis of variance, including groups 2 and 3. The second research question will be addressed with a two-way analysis of variance, including groups 1 and 2. Additionally, effect size will be calculated. The level of statistical significance will be set at p<0.05.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• knee osteoarthritis of one or both knee

• severity of knee osteoarthritis based on Kellgren-Lawrence radiographic grade 1-3

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)

• 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 3 months

• Individuals taking joint health dietary supplements, like glucosamine, chondroitin, or collagen, will need to halt use for at least 14 days before measurements to avoid affecting study outcomes

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Non-training Real Dietary Supplement (G1)
One Active Joint capsule thrice daily, and one sachet (10g) Collagen Powder Blend once daily
• Training Placebo Dietary Supplement (G2)
One Active Joint placebo capsule thrice daily, and one sachet (10g) Collagen Powder Blend placebo once daily + physical exercise (60 minutes per session twice a week)
• Training Real Dietary Supplement (G3)
One Active Joint capsule thrice daily, and one sachet (10g) Collagen Powder Blend once daily + physical exercise (60 minutes per session twice a week)

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola
Slovenia	Community Healthcare Center dr. Adolf Drolc	Maribor

Sponsors (2)

Lead Sponsor	Collaborator
University of Primorska	Community Healthcare Center dr. Adolf Drolc Maribor (HCM)

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in severity grading of knee osteoarthritis from X-ray Images at week 12	The Kellgren and Lawrence classification system is a common method of classifying the severity of osteoarthritis using five grades, range from 0 (no osteoarthritis) to 4 (severe osteoarthritis).	Baseline and week 12
Primary	Change from baseline in thickness of the articular cartilage and cross-section of muscles around knee joint at week 12	Magnetic resonance imaging of the knee is the preferred option for whole-joint evaluation in OA research (evaluation the soft tissues in and around the joint)	Baseline and week 12
Primary	Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12	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 and week 12
Primary	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
Primary	Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12	DAB-Q questionnaire for recalling a seven-day period of time use. It assesses the time spent sleeping, awake/sedentary, and engaging in physical activity within the context of 24-hour time use.	Baseline and week 12
Primary	Change from baseline in knee pain on visual analogue scale at week 12	Visual Analogue Scale (VAS) 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
Primary	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 eyes closed, with three 60-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate time of single-leg stance.	Baseline and week 12
Primary	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 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 60-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
Primary	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 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 60-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
Primary	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 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 60-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
Primary	Change from baseline in number of repetitions in Chair Stand Test at week 12	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 and 12 week
Primary	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 and 12 week
Primary	Change from baseline in number of repetitions in Arm Curl Test at week 12	An arm curl test assess upper body strength. The test involves sitting in a chair holding a weight with the palm facing the body. The arm should be against the trunk to avoid using other muscle groups. As the arm is brought through the range of motion, the wrist should rotate ending up facing the participant (supination). The number of repetitions (as many curls) in 30 seconds is used as the outcome.	Baseline and 12 week
Primary	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
Primary	Change from baseline in upper body flexibility at week 12	The Back Scratch Test measures how close the hands can be brought together behind the back. This test is done in the standing position. Investigators measure the distance between the tips of the middle fingers. Two trials are performed, and the better result is considered.	Baseline and 12 week
Primary	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
Primary	Change from baseline in maximal isometric voluntary contraction of knee flexor and extensor 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
Primary	Change from baseline in explosive strength of knee extensor at week 12	As fast and explosive contractions as possible on a knee dynamometer (S2P, Science in Practice, Ltd., Ljubljana, Slovenia) with rapid release in the direction of knee extension at selected intensities in the lower intensity range up to 60%. It is approximately 30 explosive contractions at each submaximal value (20, 40, and 60%) in a random order with each impulse verbally encouraged at intervals of 4-5 seconds.	Baseline and 12 week
Primary	Change from baseline in 24-hour time use at week 12	Assess 24-hour time use with activPAL sensors (sleep, wakefulness, sedentary behavior, physical activity).	Baseline and 12 week
Primary	Change from baseline in presence of inflammatory markers in blood sample at week 12	Blood sample analysis for the presence of inflammatory markers (TNF-a, CRP)	Baseline and week 12