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

NCT ID: NCT05195190

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-20

Study Completion Date

2022-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Clinical test

The 2 minutes walking test, the time up and go test and the 30 second sit and stand test will be applied to the patients in order. Each test will be repeated 2 times after the familiarization test and the average of the tests will be taken. There will be a 10-minute rest period between tests. For the re-test, the tests will be repeated after the patients are given a rest period of 2 hour. Testing will be conducted by a single therapist with at least 5 years of experience blinded to the study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Özlem Feyzioğlu

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Acıbadem Mehmet Ali Aydınlar University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ATADEK 2021 -21/19

Identifier Type: -

Identifier Source: org_study_id