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临床试验/NCT05731011
NCT05731011尚未招募不适用

Effects of Physical Therapy on Oxidative Stress

Baskent University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
31
试验地点
1
主要终点
antioxidant level

研究概览

简要总结

This study aimed to investigate the production of reactive oxygen derivatives (ROS) and reactive nitrogen derivatives (RNT) in female patients with knee OA, and their effects on oxidative stress by evaluating before and after physical therapy in female patients with gonarthrosis who have Kellegren-Lawrence Staging Scale Stage II and III. aimed. To this study; All female cases over the age of 40 who applied to Başkent University Ankara Hospital and were diagnosed with knee OA by a specialist doctor will be included.

Method After the cases participating in the study were checked by a specialist physician, the cases that did not prevent them from being included in the study; It will be graded according to the Kellegren-Lawrence Staging Scale. Stage II and III cases will be included in the study. Sociodemographic characteristics of the patients will be recorded before the treatment. 10 sessions of physical therapy program will be applied to the patients. Treatment program 20 minutes Hot pack (HP), 60-100 Hz frequency range, 60 pulse duration and 20 minutes of conventional TENS (Enraf-NoniusBDelftechpark 39, 2600 AV, Delft, The Netherlands) with the patient comfortable feeling and 10 minutes continuous around the knee A home exercise program will be given with ultrasound (Enraf-Nonius-B Delftechpark 39; 1-MHz; 1.5 watts/cm2) to strengthen the muscles around the knees. Those with acute inflammation of the knee joint, those who underwent surgery in the knee joint for any reason or any trauma to the lower extremity, those with a history of uncontrollable high blood pressure, any neurological or vestibular problems, those who have used steroid injections in the last two months, and any For this reason, patients with systemic diseases that will affect the study will be excluded from the study.

Staging criteria according to Kellegren-Lawrence Staging Scale; Stage 0: Normal Stage 1: Possible osteophyte Stage 2: Definite osteophyte, suspected narrowing of joint space Stage 3: Moderate osteophyte, definite narrowing Stage 4: Extensive osteophyte, marked narrowing, sclerosis (Kellegren and Lawrence, 1957).

Biochemical analyzes:

To this study; Blood samples will be taken before and after treatment from a female patient over 40 years old who was diagnosed with knee OA at Başkent University Ankara Hospital. Total antioxidant level (TAS): It will be determined by an automatic measurement method based on the fact that the characteristic color formed by the 2,2'azino-bis (3-ethylbenz-thiazoline-6-sulfonic acid) (ABTS) radical is brightened by the antioxidants in the sample added to the medium (Erel, 2004). Results will be given in mmol Trolox eqivalen/L.

Total oxidant level (TOS): will be determined by automatic measurement method (Erel, 2005). The oxidants in the sample have the task of converting the ferrous ion complex to a ferric ion. Ferric ion (Fe3+) formed by oxidation of iron (Fe2+) to its more stable form (Fe2O3) creates color with xylenol orange in acidic environment. The intensity of the color measured spectrophotometrically is related to the total amount of oxidant molecules present in the sample. The measurement is calibrated with hydrogen peroxide (H2O2) and the results will be given as micromolar H2O2 equivalent per liter (µmol H2O2 equiv./L) (Sydow, 1985).

Nitric oxide (NO): Serum nitric oxide concentration (Mirand et al, 2001) will be measured in a spectrophotometer according to the method (PowerWawe XS, BioTek, USA). Serum samples will be deproteinized with 10% zinc sulfate. In this method, nitrate was converted to nitrite with Vanadium (III) chloride. It is based on the measurement of the complex diazonium compound as a result of the reaction of nitrite and sulfanilamide N-(1-Naphthy) ethylene diamine dihydrochloride in an acidic medium.

High-density lipoprotein (HDL): It will be run in an autoanalyzer using the Biotrol trademark kit and given in mg/dl. The results will be recorded for each individual on the information sheet.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Cases with Grade II and III Study Grades according to the Kellgren-Lawrence Staging Scale
  • women over 40

排除标准

  • Patients with acute inflammation of the knee joint,
  • undergoing surgery in the knee joint for any reason or any trauma to the lower extremity,
  • a history of uncontrollable high blood pressure,
  • any neurological or vestibular problem,
  • use of steroid injections in the last two months,
  • any cases with systemic disease that may affect the study

结局指标

主要结局

antioxidant level

时间窗: 2 months

Blood samples will be taken before and after treatment. Total antioxidant level (TAS): It will be determined by an automatic measurement method based on the fact that the characteristic color formed by the 2,2'azino-bis (3-ethylbenz-thiazoline-6-sulfonic acid) (ABTS) radical is brightened by the antioxidants in the sample added to the medium (Erel, 2004). Results will be given in mmol Trolox eqivalen/L.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mustafa gulsen

assocc.prof.

Baskent University

研究点 (1)

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