Prostate CancerNCT05195190
Validity, Reliability and Minimum Detectable Changes of 2-Minute Walk , Timed Up and Go, Sit and Stand Test in Patients With Prostate Cancer
An observational study of Prostate Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Clinical test
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2022to 20 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- Men only
- Adult, Older adult
Study population: Volunteer patients between 55 and 75 years of age with non metastatic prostate cancer will be recruited by simple randomization.
Who may be able to join
- 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
Who cannot join
- Diagnosed with metastatic prostate cancer
- Uncontrollable cardiovascular disease Uncontrollable insulin due to diabetes Individuals with neuromuscular, metabolic disease that may effect physical tests
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Mehmet Ali Aydınlar University
Istanbul
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Clinical test
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical testOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
2 minute walk test -2MWT
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
Measured: 2 hours
Time Up and Go Test
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.
Measured: 2 hours
Sit and Stand Test
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.
Measured: 2 hours
Secondary outcomes (1)
Nottingham Health Profile -NHP
The Turkish version of the NHP will be used to assess health-related quality of life. NHP is a general quality of life questionnaire that measures the perceived health problems of the individual and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items and evaluates 6 sub-dimensions related to health status. Energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). Questions are answered with yes or no. Each section is scored between 0-100. 0 indicates best health, 100 indicates worst health
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start20 Feb 2022
- Primary completion20 Jun 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Feyzioğlu, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195190
- Sponsor's protocol ID
- ATADEK 2021 -21/19
- Status last verified
- Jun 2022
- First submitted
- 14 Dec 2021
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05195190
- Acronym / sponsor ID
- ATADEK 2021 -21/19
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients between 55 and 75 years of age with non metastatic prostate cancer will be recruited by simple randomization.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with metastatic prostate cancer
- Uncontrollable cardiovascular disease Uncontrollable insulin due to diabetes Individuals with neuromuscular, metabolic disease that may effect physical tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical testThe 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. | Other | – |
Primary outcome
2 minute walk test -2MWT
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Nottingham Health Profile -NHP
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 minute walk test -2MWT (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.