Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269549
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-13
Brief Title:
Kinesiological Dietary Supplement Intervention in Knee Osteoarthritis
Sponsor:
University of Primorska
Organization:
University of Primorska
Study Overview
Official Title:
Effectiveness of Kinesiological and Dietary Supplement Intervention in Individuals With Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KDSKOA
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
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 doctors 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 111 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 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 p005
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 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 p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None