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临床试验/NCT05019820
NCT05019820Unknown4 期

Identification of Sarcopenia in Knee Osteoarthritis With Ultrasonography and Evaluation of Muscle Architecture Change by Ultrasonography After Isokinetic Exercise Program

Sema Dağcı2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月18日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
60
试验地点
2
主要终点
Muscle architecture

研究概览

简要总结

The aim of this thesis; To define sarcopenia in knee osteoarthritis with ultrasonography and to evaluate changes in muscle structure in sarcopenia after isokinetic exercise application ultrasonographically. The investigators will evaluate the effect of isokinetic exercise therapy in sarcopenic patients with knee osteoarthritis with VAS (Visual Analog Scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Then, the hand grip strength will be evaluated with a dynamometer, and its effects on physical performance will be evaluated by 6 meters walking and chair rising tests.

详细描述

Among the 45-65 age group who applied to Mustafa Kemal University Faculty of Medicine, Physical Medicine and Rehabilitation outpatient clinic, 30 female patients diagnosed with knee osteoarthritis (stage 1-2-3) and sarcopenia together, and 30 individuals without osteoarthritis and sarcopenia will be included in the study as the control group.Patients with knee osteoarthritis who have been diagnosed with sarcopenia by ultrasonography will be Group I, and the control group without osteoarthritis and sarcopenia will be Group II.30 patients in Group I will be given an exercise program with isokinetic dynamometer for both knees, 30 minutes of TENS (transcutaneous electrical nerve stimulation), 20 minutes of hot packs, and home exercise program will be given lower extremity strengthening for a total of 6 weeks (18 sessions), 3 sessions per week.A diet program (protein, mineral, vitamin D supplemented) will also be given to these patients. The control group, which is group II, will be offered a home exercise program and diet for lower extremity strengthening only.Those with a history of complicated Diabetes Mellitus, Severe Coronary Artery Disease / Congestive Heart Failure, severe Liver Failure, neuromuscular disease, previous lower extremity surgery, rheumatological disease, use of walking aids will not be included in the study.The patient group and control group pre-treatment (week 0) and post-treatment (week 6) clinical; hand grip strength will be evaluated with Jamar dynamometer, walking speed will be evaluated with 6 meters walking test, lower extremity endurance will be evaluated with chair rise test, functional assessment of knee osteoarthritis will be evaluated by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and pain assessment will be evaluated by VAS (Visual Analogue scale) will be evaluated with a pain questionnaire.In addition, changes in the Rectus Femoris and Vastus Lateralis muscle architecture on the dominant side of the patients; muscle thickness, fascicle length, echogenicity, pennation angle and cross-sectional area measurements will be evaluated before treatment (0 weeks) and after treatment (6 weeks) by ultrasonography.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Among the 45-65 age group, 30 female patients diagnosed with knee osteoarthritis (Stage 1-2-3) and sarcopenia together
  • Among the 45-65 age group, 30 females without osteoarthritis and sarcopenia will be included in the study as the control group.

排除标准

  • Diabetes Mellitus,
  • Severe Coronary Artery Disease / Congestive Heart Failure,
  • Severe Liver Failure,
  • Neuromuscular disease,
  • Lower extremity surgery,
  • Rheumatological disease,
  • Those who use walking aids

结局指标

主要结局

Muscle architecture

时间窗: Six weeks

Determination of muscle architecture change with ultrasonography after isokinetic exercise

次要结局

  • Hand grip strength(Six weeks)
  • Time to get out of the chair(Six weeks)
  • Walking speed(Six weeks)
  • Knee pain(Six weeks)
  • Functional status(Six weeks)

研究者

发起方
Sema Dağcı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sema Dağcı

Principal Investigator

Mustafa Kemal University

研究点 (2)

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