Exercise on microRNA in Osteoarthritis

NCT05869630 | Completed

• 1 other identifier: OA_exercise_microrna
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee; Epigenetic Disorder; Quality of Life; Depression; Pain

Keywords

Osteoarthritis; Epigenetic Disorder; Quality of Life; Depression; Pain

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

• 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

• 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

• 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 Outcomes (3)

• Short Form-36 (SF-36)

  At the beginning of the intervention and through study completion, an average of 2 month

• Beck Depression Inventory (BDI)

  At the beginning of the intervention and through study completion, an average of 2 month

• Numeric Rating Scale (NRS)

  At the beginning of the intervention and through study completion, an average of 2 month

Study Arms (1)

Exercise Group

EXPERIMENTAL

A total of 30 knee OA patients and 30 age/sex-matched healthy volunteers were included in the exercise and control groups. Exercises were 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 were taken from both groups. miRNA-146a, miRNA-155, miRNA-221-3p and miRNA-145 gene expressions were studied with the Real-time PCR method. miRNA-146a, miRNA-155, and miRNA-221-3p, miRNA-145 gene expressions were studied with the Real-time PCR method. The pain was 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).

Other: Exercise Programme; Other: Experiments

Interventions

Exercise Programme OTHER

All patients were informed about knee OA, joint protection principles, and the exercise effects on knee OA before treatment. The exercises were supervised by a physiotherapist for 30 minutes twice a week and once a week as a home program. The exercise program consisted of a warm-up, strengthening knee extensors and lower extremity stretching exercises. Firstly, quadriceps isometric and adductor isometric (roll tightening) exercises, hamstring stretching, quadriceps stretching, and gastrocnemius stretching were applied. Then, hip flexion-extension-abduction-adduction, and knee extension while sitting were applied with exercise bands. Strengthening exercises were composed of three sets with 10 repetitions. Stretching exercises were performed 10 repetitions for 10 seconds.

Exercise Group

Experiments OTHER

The total RNA was isolated from peripheral blood samples taken from patients and the control group by applying the protocol of the manufacturer (LucigenMasterPure™ Complete DNA and RNA Purification Kit, USA). The total RNA was isolated in three steps: Lysis stage of the whole blood samples, precipitation of nucleic acids and precipitation of total RNA. The purity and concentration of the isolated total RNA samples were measured with the spectrophotometer (Thermo Fischer) device. The samples were stored at -80°C until the next step. To determine the microRNA expression levels; firstly, conjugate DNA (cDNA) was synthesized from total RNA samples according to the manufacturer's protocol. Whether the desired region reproduced in the reaction and whether there were primer dimers were checked by adding a melting curve step. In addition, blood samples of 30 age-sex matched healthy volunteers were compared.

Exercise Group

Eligibility Criteria

• Age: 38 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Hospital Research Hospital, Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Depression; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fulya Senem KARAAHMETOĞLU, M.Sc

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Zeynep Betül ÖZCAN, M.Sc

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Meltem VURAL, Prof. Dr.

  Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospita

  STUDY CHAIR

• Işıl ÜSTÜN, Dr.

  Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospita

  STUDY CHAIR

• Alev KURAL, Prof. Dr.

  Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospita

  STUDY CHAIR

• Sibel KURAŞ, M. Sc.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Bekir ERDOĞAN, M.Sc

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Halime Hanım PENÇE, Assoc. Prof.

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Cohort Study

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 22, 2023
• Study Start: August 1, 2018
• Primary Completion: September 11, 2019
• Study Completion: June 17, 2020
• Last Updated: June 6, 2023

Record last verified: 2023-05

Locations

TU (1)