Clinical trial NCT05997966: Investigation of the Effects of Progressive Resistance Exercises in Individuals With Knee Osteoarthritis
Official title: Investigation of the Effects of Progressive Resistance Exercises on Pain, Functional Activity, Quality of Life and Serum Biomarkers in Individuals With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Exercise Training
Biomarkers
Keywords: Osteoarthritis, Knee
Exercise Training
Pain
Functional Status
Biomarkers
Quality of Life
Lead sponsor: Beykoz University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Having signed the informed consent form,
* Male and postmenopausal female patients aged 50 and over,
* Radiologically and clinically diagnosed with Stage 1 or 2 knee OA,
* Patients with a sedentary life (patients with less than 45 minutes of moderate-intensity activity per week)

Exclusion Criteria:

* Cooperative problem or cognitive impairment,
* BMI \> 35 kg/m2,
* Receiving physiotherapy in the last 3 months,
* Steroid injection to the knee joint in the last 6 months,
* Presence of neuromuscular or neurodegenerative disease,
* Presence of cardiorespiratory disease, previous hip, knee, foot-ankle surgeries,
* Use of immunosuppressive drugs,
* Presence of infection or inflammatory disease in any part of the body.

Primary outcomes:
measure: Chair Stand Test
timeFrame: Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
measure: Timed Up and Go Test
timeFrame: Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
measure: Range of Motion
timeFrame: Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
measure: Muscle Strength
timeFrame: Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
measure: Serum Inflammatory Level
timeFrame: Blood collection will be done before treatment (week 0) and after treatment (week 13) to examine serum biomarker levels with ELISA kits.
measure: Visual Analogue Scale (VAS)
timeFrame: Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
measure: Quality of Life Scale-Short Form (SF-12)
timeFrame: Evaluations will be repeated before treatment (week 0), weeks 5 and 9, and post treatment (13 weeks).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medipol University
name: Meltem Meran Çağlar
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: bayram ünver
role: STUDY_DIRECTOR
affiliation: Istanbul Gelisim University
name: eda merve kurtuluş
role: STUDY_CHAIR
affiliation: istanbul özel sondurak ümran tıp merkezi
name: mustafa tekkeşin
role: STUDY_CHAIR
References: