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临床试验/NCT05195190
NCT05195190已完成不适用

Validity, Reliability and Minimum Detectable Changes of 2-Minute Walk , Timed Up and Go, Sit and Stand Test in Patients With Prostate Cancer

Acibadem University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
2 minute walk test -2MWT

研究概览

简要总结

Prostate cancer is a type of cancer that can occur in men, especially in the fifth and sixth decades of their lives, and various side effects occur depending on the treatments applied in the diagnosed patients. The treatments applied and the decreased level of physical activity also cause a decrease in the quality of life. Recent studies have focused on treatment-related side effects. Before treatment planning, there is a need for clinically validated clinical evaluations specific to prostate cancer patients in order to determine the current status of the patients or to measure the effectiveness of the treatment applied. In addition, tests with a minimal detectable amount of change will be guiding in order to understand that the effectiveness of the applied treatment is significant. The aim of our study is to investigate the validity, reliability and minimal detectable changes of the two-minute walk, sit up and time up and go tests validated in different disease groups for patients with prostate cancer.

详细描述

Performance-based outcome measures are gaining importance in terms of patients' health care. These tests are not specific for any disease or extremity. They are specific tests for walking and getting up from a chair. They evaluate what an individual can do rather than what they perceive the individual can do. Performance measurement tests have a higher level of evidence than just self-reported evaluations.

Time up and go test, two-minute walk test, sit and stand test are the most frequently used tests in the clinic to evaluate functionality. The short duration of the tests and the fact that they do not require equipment provide advantages in the clinical setting.

In the current literature, the validity and reliability of the Time up and go, two-minute walk and sit-up test in elderly prostate cancer patients has not been established. The aim of our study is to investigate the validity and reliability of these tests in elderly prostate cancer patients and to determine their minimum detectable change. Our second aim is to investigate the relationship of these tests we evaluated with the Nottingham Health Profile questionnaire, which evaluates health-related quality of life in elderly cancer patients.

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
55 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Receiving or continuing Androgen deprivation therapy for at least 3 months
  • •Diagnosed with non-metastatic prostate cancer
  • •In the process of radiotherapy or chemoradiotherapy
  • •Able to walk without assistive device
  • •Patients over 55 years of age

排除标准

  • •Diagnosed with metastatic prostate cancer
  • •Uncontrollable cardiovascular disease Uncontrollable insulin due to diabetes Individuals with neuromuscular, metabolic disease that may effect physical tests

结局指标

主要结局

2 minute walk test -2MWT

时间窗: 2 hours

You will be instructed to "walk at a comfortable, usual pace". There will be two attempts for application trial and registration. Practice trial will be used to minimize any potential learning impact. After resting for at least 10 minutes between trials, the distance traveled in 2 minutes will be recorded as 2MWT. The average of both tests will be taken

Time Up and Go Test

时间窗: 2 hours

It is the time measured when an individual is standing, walking 3 m straight, returning to the chair, and sitting. In the study, the you will sit comfortably in a chair without back support and arm support. The time for the test will begin as soon as you get up from the chair and will end after you sit in the chair. If the test is less than 10 seconds, it indicates functional independence, and if it is over 30 seconds, it indicates functional dependence.

Sit and Stand Test

时间窗: 2 hours

It is used to measure lower extremity strength and evaluate physical capacity. For this study, you will be asked to get up and sit as much as they can within 30 seconds from a chair with a standard 17-inch sitting height and back support.

次要结局

  • Nottingham Health Profile -NHP(through study completion, an average of 6 months)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Feyzioğlu

Assistant professor

Acibadem University

研究点 (1)

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