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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06449898
Other study ID # 2023/04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2023
Est. completion date November 12, 2023

Study information

Verified date June 2024
Source Kirsehir Ahi Evran Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date November 12, 2023
Est. primary completion date September 10, 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
hemodialysis group
Data were collected from patients undergoing treatment at a hemodialysis center in Kirsehir. 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.

Locations

Country Name City State
Turkey Mehmet Hanifi KAYA Kirsehir

Sponsors (1)

Lead Sponsor Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 weeks
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