Depression Clinical Trial
Official title:
Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Knee Osteoarthritis
Verified date | May 2023 |
Source | Saglik Bilimleri Universitesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 30 |
Est. completion date | June 17, 2020 |
Est. primary completion date | September 11, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 38 Years to 75 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Turkey | Bakirköy Dr. Sadi Konuk Training and Hospital Research Hospital, Physical Medicine and Rehabilitation | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre-Treatment Gene Expressions of microRNA for Treatment Group | By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down. | Baseline | |
Primary | Post-Treatment Gene Expressions of microRNA for Treatment Group | By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down. | Through study completion, an average of 2 months. | |
Primary | Gene Expressions of microRNA for Healthy Control Group | By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down. | Baseline | |
Primary | Pre-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group | WOMAC was used to evaluate functional status. There are a total of 24 questions on pain, morning stiffness and physical function.
0 points means 'not at all', 1 point means 'mild', 2 points 'moderate', 3 points 'severe', 4 points 'very severe'. The total score is between 0 and 100, and a low score means that the individual is in good health. |
Baseline | |
Primary | Post-Treatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for Treatment Group | WOMAC was used to evaluate functional status. There are a total of 24 questions on pain, morning stiffness and physical function.
0 points means 'not at all', 1 point means 'mild', 2 points 'moderate', 3 points 'severe', 4 points 'very severe'. The total score is between 0 and 100, and a low score means that the individual is in good health. |
At the beginning of the intervention and through study completion, an average of 2 month | |
Secondary | Short Form-36 (SF-36) | SF-36 was used to evaluate quality of life. This questionnaire consists of eight subsections. Scoring is made between 0-100 for each of the subsections. Higher scores indicate better function and well-being. | At the beginning of the intervention and through study completion, an average of 2 month | |
Secondary | Beck Depression Inventory (BDI) | BDI was used to evaluate depression level. The test consists of 20 questions and each question includes 0, 1, 2, 3 points.
takes. At the end of the test; The scores marked by the patient for each question are summed up and the depression status is evaluated according to the score. The higher the score, the higher the level of depression. |
At the beginning of the intervention and through study completion, an average of 2 month | |
Secondary | Numeric Rating Scale (NRS) | NRS was used to pain level. A score of 0 means 'no pain' and a score of 10 means 'unbearable pain'. | At the beginning of the intervention and through study completion, an average of 2 month |
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