Clinical trial NCT05869630: Exercise on microRNA in Osteoarthritis
Official title: Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Epigenetic Disorder
Quality of Life
Depression
Pain
Keywords: Osteoarthritis
Epigenetic Disorder
Quality of Life
Depression
Pain
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 38
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort Study
Primary purpose: TREATMENT

Brief summary: The present study is a prospective cohort study. This study will be conducted to determine the change in miRNA levels with exercise in knee Osteoarthritis (OA) patients. The main questions that the study aims to answer are:

Question 1: Does exercise therapy affect microrna expressions in patients with knee osteoarthritis?

Question 2: Does exercise therapy affect quality of life, pain, functional status and depression level in patients with knee osteoarthritis?

Participants; demographic information such as age, height, weight will be questioned. Exercises will performed twice a week under supervision and once a week as home program for eight weeks. Before and after exercise treatment, peripheral venous blood samples will taken from both groups. miRNA-146a, miRNA-155, miRNA-221-3p and miRNA-145 gene expressions will studied with the real-time PCR (polymerase chain reaction) method. miRNA-146a, miRNA-155, and miRNA-221-3p, miRNA-145 gene expressions will studied with the Real-time PCR method. The pain will evaluated with the Numeric Rating Scale (NRS), functional status with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), depression level with the Beck Depression Inventory (BDI), and quality of life with Short Form-36 (SF-36).

Detailed description: Osteoarthritis is a degenerative disease causing joint pain, stiffness, and limitation of motion with loss of cartilage, osteophyte development, subchondral sclerosis, changes in the joint capsule and synovial membrane as a result of the disruption of genetic, biomechanical, and biochemical balances. Pharmacological treatments of osteoarthritis include simple analgesics, non-steroidal anti-inflammatory drugs, opioids and topical analgesics. Patient education, self-management programs, exercise, weight loss, assistive devices and lifestyle changes are non-pharmacological treatment methods.Exercise is one of the basic elements of the treatment modality. The purpose of the exercise; to relieve symptoms and improve muscle strength around joints. It is aimed to increase the quality of life with the adaptation of individuals to exercise.

miRNA, one of the small non-coding RNA subunits, is responsible for the modulation of protein-coding genes as a result of post-transcriptional repression. miRNA play an active role in many biological events such as cellular differentiation, apoptosis, proliferation, erythropoiesis, fibrosis and angiogenesis. Due to the role of miRNAs in normal development and diseases, it is thought that they will be a new biomarker for therapeutic purposes in the future. It was found that miRNAs play a key role in physiological conditions e.g. skeletal muscle hypertrophy, mitochondrial biogenesis, vascular angiogenesis, and metabolic events when combined with exercise. The identification of miRNAs that change in circulation with exercise is important in terms of providing new data on the physiological adaptation of exercise. In recent years, a large number of miRNAs have been identified in osteoarthritic tissues, which is important in terms of the regulation of gene expressions related to the pathogenesis of OA. OA-specific miRNA expressions is necessary for early diagnosis and treatment of OA as well as for monitoring the progression of the disease. It has been reported that miRNA-146a is intensely expressed in OA tissue and its expression is induced by inflammatory cytokines. MiRNA-145 is associated with chondrocyte homeostasis and is thought to be involved in the degradation of the extracellular matrix. MiRNA-155 is a miRNA that has a role in the development and regulation of innate and acquired immunity, and its expression is increased in tissues with OA compared to healthy tissue. It has an important role in hematopoiesis. MiRNA-221-3p was found to be associated with chondrocyte proliferation, gene expression, matrix degradation and apoptosis.

In this study it was aimed to determine the changes in miRNA levels of knee OA patients with exercise.

Eligibility criteria: Inclusion Criteria:

* Having Kellgren-Lawrence grade 2 or grade 3 knee OA
* Body mass index (BMI) between 20-35.

Exclusion Criteria:

* Rheumatoid Arthritis,
* Having knee replacement surgery,
* Intra-articular injection in the last six months,
* Usage of opioid analgesics or corticosteroids,
* Being under severe pain (VAS\>7),
* Pregnancy,
* Having cardiovascular disease,
* Stroke and chronic obstructive pulmonary disease (COPD).

Primary outcomes:
measure: Pre-Treatment Gene Expressions of microRNA for Treatment Group
timeFrame: Baseline
measure: Post-Treatment Gene Expressions of microRNA for Treatment Group
timeFrame: Through study completion, an average of 2 months.
measure: Gene Expressions of microRNA for Healthy Control Group
timeFrame: Baseline
measure: Pre-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group
timeFrame: Baseline
measure: Post-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group
timeFrame: At the beginning of the intervention and through study completion, an average of 2 month
Secondary outcomes:
measure: Short Form-36 (SF-36)
timeFrame: At the beginning of the intervention and through study completion, an average of 2 month
measure: Beck Depression Inventory (BDI)
timeFrame: At the beginning of the intervention and through study completion, an average of 2 month
measure: Numeric Rating Scale (NRS)
timeFrame: At the beginning of the intervention and through study completion, an average of 2 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Training and Hospital Research Hospital, Physical Medicine and Rehabilitation
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Fulya Senem KARAAHMETOĞLU, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Zeynep Betül ÖZCAN, M.Sc
role: STUDY_CHAIR
affiliation: Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospita
name: Meltem VURAL, Prof. Dr.
role: STUDY_CHAIR
affiliation: Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospita
name: Işıl ÜSTÜN, Dr.
role: STUDY_CHAIR
affiliation: Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospita
name: Alev KURAL, Prof. Dr.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Sibel KURAŞ, M. Sc.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Bekir ERDOĞAN, M.Sc
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Halime Hanım PENÇE, Assoc. Prof.
role: STUDY_DIRECTOR
References: