Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2025-12-24 @ 4:00 PM
NCT ID:
NCT05997966
Brief Summary:
It is known that the global socioeconomic burden of individuals with knee osteoarthritis (OA) is on a constantly rising curve. In addition, it is predicted that this burden will increase with the increase in the aging rate of countries. While the evidence level of exercise in the treatment of individuals with knee OA is at A level, a standard exercise program has still not been established for these individuals. One of the most important elements in establishing a standard exercise protocol can be realized by understanding how exercise provides positive effects in these individuals. Today, the gold standard practice used in examining the effectiveness of treatments such as exercise is the follow-up of biomarkers. However, for this purpose, biological fluids (blood, urine, synovial fluid) samples are not taken from individuals with knee OA during routine health controls. Existing laboratory detection methods, especially ELISA analysis, are very detailed, time-consuming and expensive, among the reasons why they cannot be included in routine clinical practice. This situation makes it difficult to examine which biomarkers the exercise programs applied in individuals with knee OA have an effect on and to establish a standard exercise protocol. Therefore, the number of randomized controlled studies examining this issue is very few in the literature, and this number is much less in Turkey. The researchers aimed to create a standard home-based exercise program by examining the effects of the holistic exercise approach for all lower extremity muscles, which the researchers created considering the EMG studies in the literature for individuals with knee OA and the age group to be included in the study, both at the physical (pain, functional status, quality of life) and biochemical level (inflammatory biomarkers that have not been examined together before and whose relationship with OA has been newly discovered).
Detailed Description:
The researchers aim to evaluate the effectiveness of a home-based holistic progressive resistance exercise program for all lower extremity muscles (hip, knee and ankle circumference) in individuals with knee OA in detail and in a multifaceted manner. In addition, the researchers aim to examine the effect of exercise on serum biomarkers in order to understand whether exercise has an anti-inflammatory effect in these individuals and to establish standard exercise protocols. Thus, when a standard home-based exercise program can be established, it will be ensured that elderly individuals with knee OA, who have problems in reaching health centers, have difficulty in going out due to different health problems, and who are the primary care treatment, will be able to do exercises at home. At the same time, considering the global socioeconomic burden of knee OA, the researchers predict that the home-based exercise program will contribute positively to the country's economy.
All subjects who voluntarily accepted to participate in the study and met the inclusion criteria will be applied four times during the 12-week exercise program (except for the blood draw required for the evaluation of serum biomarker levels). Pain intensity, functional status based on performance and scales, quality of life, lower extremity range of motion, lower extremity muscle strength assessments will be repeated before treatment (0 weeks), 5th and 9th weeks, and after treatment (13th week). These assessments will be made at patients' homes. Blood collection will be done before treatment (week 0) and after treatment (week 13) to examine serum biomarker levels with ELISA kits.
Study:
NCT05997966
Study Brief:
Protocol Section:
NCT05997966