Clinical trial NCT06269549: Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis
Official title: Effectiveness of Kinesiological and Dietary Supplement Intervention in Individuals With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: exercise
physical activity
dietary supplement
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: Community Healthcare Center dr. Adolf Drolc Maribor (HCM)
First posted: 2024-02-21
Enrollment: 93
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time)
Primary purpose: SUPPORTIVE_CARE

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:

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.

Detailed 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, and at a 6-week follow-up.

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 2x2 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 and at a 6-week follow-up
timeFrame: Baseline, week 12 and at a 6-week follow-up
measure: Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in knee pain on numeric rating scale at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in 40 metre fast-paced walk at week 12 and at a 6-week follow-up
timeFrame: Baseline, week 12 and at a 6-week follow-up
measure: Change from baseline in static balance time at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in number of repetitions in Chair Stand Test at week 12 and at a 6-week follow-up
timeFrame: Baseline, 12 week and at a 6-week follow-up
measure: Change from baseline in time for Five Times Sit to Stand Test at week 12
timeFrame: Baseline, 12 week and at a 6-week follow-up
measure: Change from baseline in lower body flexibility at week 12
timeFrame: Baseline and 12 week
measure: Change from baseline in Timed up-and-go test (TUG) at week 12 and at a 6-week follow-up
timeFrame: Baseline, week 12 and at 6-week follow-up
measure: Change from baseline in 10-Step Stair Climb Test (SCT) at week 12 and at a 6-week follow-up
timeFrame: Baseline, week 12 and at 6-week follow-up
measure: Change from baseline in 6-minute walk distance at week 12
timeFrame: Baseline and 12 week
measure: Change from baseline in maximal isometric voluntary contraction of knee flexors and extensors at week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change from baseline in presence of inflammatory markers in blood sample at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in 24-hour time use at week 12
timeFrame: Baseline and 12 week
measure: Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in handgrip strength at week 12
timeFrame: Baseline and week 12
measure: Change from baseline in number of repetitions in Arm Curl Test at week 12
timeFrame: Baseline and 12 week
measure: Change from baseline in upper body flexibility at week 12
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
city: Maribor
country: Slovenia
facility: Community Healthcare Center dr. Adolf Drolc
Study officials:
affiliation: University of Primorska, Faculty of Health Sciences
name: Nejc Šarabon, PhD
role: STUDY_CHAIR
References: