Chronic Kidney DiseasesNCT06449898
Validity and Reliability of the Turkish Version of the Ottawa Sitting Scale in Hemodialysis Patients With Chronic Kidney Disease
A study testing hemodialysis group in people with Chronic Kidney Diseases, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Background: Prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (CKD) patients undergoing hemodialysis. This sedentary behavior can lead to various health complications and a reduced quality of life (QOL). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- hemodialysis group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2023to 12 Nov 2023
- Phase
- Interventional
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of CKD undergoing hemodialysis treatment for at least 6 months no abnormalities in cooperation or communication, and willingness to participate in the study.
Who cannot join
- Inability to comprehend instructions
- Presence of any other disease that may affect sitting
- Experiencing acute or chronic musculoskeletal injuries, pain, inflammation or deformities, and refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (CKD) patients undergoing hemodialysis. This sedentary behavior can lead to various health complications and a reduced quality of life (QOL).
Read more
Objectives:
This study aims to evaluate the validity and reliability of the Turkish adaptation of the Ottawa Sitting Scale (OSS) in assessing sitting behavior among CKD patients.
Methods:
A total of 130 CKD patients undergoing hemodialysis participated in this cross-sectional study conducted in XXX province between January 2023 and September 2023. The OSS, along with the Physical Activity Scale (FAS), Sitting Behavior Assessment (SBA), and Quality of Life Scale (QOL), was administered. Data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the OSS.
Read the detailed description
Prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (CKD) patients undergoing hemodialysis. This sedentary behavior can lead to various health complications and a reduced quality of life.This study aims to evaluate the validity and reliability of the Turkish adaptation of the Ottawa Sitting Scale (OSS) in assessing sitting behavior among CKD patients. A total of 130 CKD patients undergoing hemodialysis participated in this cross-sectional study conducted in XXX province between January 2023 and September 2023. The OSS, along with the Physical Activity Scale (FAS), Sitting Behavior Assessment (SBA), and Quality of Life Scale (QOL), was administered. Data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the OSS.
- Conditions
- Chronic Kidney Diseases
- Being tested
- hemodialysis group
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodialysis groupOther
Data were collected from patients undergoing treatment at a hemodialysis center in Kırşehir. Participants were informed about the study objectives and provided written consent. Data collection took approximately 20-30 minutes per participant and included a face-to-face interview where socio-demographic and clinical information was recorded.
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis group | Other | Undergoing hemodialysis treatment for at least 6 months. Receives: Other: hemodialysis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottawa Sitting Scale (OSS):
The OSS is a 6-item scale designed to assess sitting balance. Each item is performed with feet supported and unsupported, resulting in a total of 12 items. A 4-point Likert-type response scale was used for each item. The total score ranges from 0 to 48, with higher scores indicating better sitting behavior. The cross-cultural adaptation of the OSS followed the guidelines by Beaton et al. (2000), involving forward and backward translations, synthesis, expert committee review, and pre-testing on 30 elderly adults.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start7 Jan 2023
- Primary completion10 Sep 2023
- Study completion12 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The sample size was determined based on the recommendations for validation studies, which suggest a minimum of 5 to 10 participants per item on the scale being validated. Given that the OSS comprises 12 items, a minimum of 60 participants was deemed necessary. However, to account for potential dropouts and to enhance the robustness of the findings, 130 participants were recruited.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Hanifi Kaya, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449898
- Sponsor's protocol ID
- 2023/04
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Ottawa Sitting Scale in Hemodialysis Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06449898
- Acronym / sponsor ID
- 2023/04
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 12 Nov 2023 (actual)
- First posted
- 10 Jun 2024 (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.
Background:
Prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (CKD) patients undergoing hemodialysis. This sedentary behavior can lead to various health complications and a reduced quality of life (QOL).
Objectives:
This study aims to evaluate the validity and reliability of the Turkish adaptation of the Ottawa Sitting Scale (OSS) in assessing sitting behavior among CKD patients.
Methods:
A total of 130 CKD patients undergoing hemodialysis participated in this cross-sectional study conducted in XXX province between January 2023 and September 2023. The OSS, along with the Physical Activity Scale (FAS), Sitting Behavior Assessment (SBA), and Quality of Life Scale (QOL), was administered. Data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the OSS.
Detailed description
Prolonged sitting behavior, characterized by minimal energy expenditure, poses significant health risks, especially for chronic kidney disease (CKD) patients undergoing hemodialysis. This sedentary behavior can lead to various health complications and a reduced quality of life.This study aims to evaluate the validity and reliability of the Turkish adaptation of the Ottawa Sitting Scale (OSS) in assessing sitting behavior among CKD patients. A total of 130 CKD patients undergoing hemodialysis participated in this cross-sectional study conducted in XXX province between January 2023 and September 2023. The OSS, along with the Physical Activity Scale (FAS), Sitting Behavior Assessment (SBA), and Quality of Life Scale (QOL), was administered. Data analysis involved assessing the internal consistency, factor structure, and concurrent validity of the OSS.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The sample size was determined based on the recommendations for validation studies, which suggest a minimum of 5 to 10 participants per item on the scale being validated. Given that the OSS comprises 12 items, a minimum of 60 participants was deemed necessary. However, to account for potential dropouts and to enhance the robustness of the findings, 130 participants were recruited.
| Arm | Type | Receives |
|---|---|---|
| hemodialysis group | Other | Other: hemodialysis groupUndergoing hemodialysis treatment for at least 6 months. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a diagnosis of CKD undergoing hemodialysis treatment for at least 6 months no abnormalities in cooperation or communication, and willingness to participate in the study.
Key exclusion criteria (3 listed)
- Inability to comprehend instructions
- Presence of any other disease that may affect sitting
- Experiencing acute or chronic musculoskeletal injuries, pain, inflammation or deformities, and refusal to participate in the study.
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 |
|---|---|---|
| hemodialysis groupData were collected from patients undergoing treatment at a hemodialysis center in Kırşehir. Participants were informed about the study objectives and provided written consent. Data collection took approximately 20-30 minutes per participant and included a face-to-face interview where socio-demographic and clinical information was recorded. | Other | hemodialysis group |
Primary outcome
Ottawa Sitting Scale (OSS):
Time frame: 24 weeks
The OSS is a 6-item scale designed to assess sitting balance. Each item is performed with feet supported and unsupported, resulting in a total of 12 items. A 4-point Likert-type response scale was used for each item. The total score ranges from 0 to 48, with higher scores indicating better sitting behavior. The cross-cultural adaptation of the OSS followed the guidelines by Beaton et al. (2000), involving forward and backward translations, synthesis, expert committee review, and pre-testing on 30 elderly adults.
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 10 Jun 2024.
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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?
A study testing hemodialysis group in people with Chronic Kidney Diseases, run by Kirsehir Ahi Evran Universitesi 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 1 inclusion and 3 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 10 Jun 2024. 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?
Ottawa Sitting Scale (OSS): (time frame: 24 weeks). 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 10 Jun 2024.