Clinical trial NCT05195190: Validity, Reliability and Minimum Detectable Changes of 2-Minute Walk , Timed Up and Go, Sit and Stand Test in Patients With Prostate Cancer
Official title: Validity, Reliability and Minimum Detectable Changes of 2-Minute Walk , Timed Up and Go, Sit and Stand Test in Patients With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 80
Sex: MALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer patients between 55 and 75 years of age with non metastatic prostate cancer will be recruited by simple randomization.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 2 minute walk test -2MWT
timeFrame: 2 hours
measure: Time Up and Go Test
timeFrame: 2 hours
measure: Sit and Stand Test
timeFrame: 2 hours
Secondary outcomes:
measure: Nottingham Health Profile -NHP
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University
Study officials:
References: