NCT06449898

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 4, 2024

Last Update Submit

June 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

hemodialysis group

OTHER

Undergoing hemodialysis treatment for at least 6 months.

Other: hemodialysis group

Interventions

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.

hemodialysis group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Hanifi KAYA

Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pilot Project Manager Lecturer Doctor.

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 10, 2024

Study Start

January 7, 2023

Primary Completion

September 10, 2023

Study Completion

November 12, 2023

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations