Sponsor study identifier
observational
100
1 country
1
Study Start
August 12, 2021
Actual (reported)Primary Completion
February 10, 2022
Actual (reported)Study Completion
February 10, 2022
Actual (reported)Axial Spondyloarthritis is an inflammatory arthritis disease and its main symptoms are chronic pain and stiffness, causing structural damage to the spinal vertebrae. Axial Spondyloarthritis leads to physical disability and a decrease in the level of physical activity. Frailty is a syndrome characterized by decline in physiological reserve and loss of muscle strength. Frailty can lead to vulnerability of individuals to possible injuries and a decrease in independence, and ultimately an increase in mortality. Although frailty is associated with older adults, it has been reported that it can be detected in patients with cancer, diabetes and rheumatological diseases and it is not related with age. Frailty has been reported to be a reversible and a treatable condition. The aim of our study was to investigate the prevalence of frailty and the relationship between frailty and disease activity, physical functional level, quality of life and other associated factors in individuals with Axial Spondyloarthritis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2021
Actual (reported)August 12, 2021
Actual (reported)August 18, 2021
Actual (reported)February 10, 2022
Actual (reported)February 10, 2022
Actual (reported)Fried Frailty Phenotype
The frailty level of the participants included in the study will be determined according to the frailty phenotype criteria of Fried et al. criteria for the diagnosis of frailty; Decreased grip strength, walking speed for 4 meters is less than the determined metrics ( for people who are 159 cm and shorter as \<6.12 sec or \>5.25 sec for those 159 cm and above), involuntary weight loss in the last year (≥4.5 kg) or body mass index ≤18.5 kg/m2, low physical activity level, and increased fatigue level reported by the participant. Individuals meeting 3 or more of these criteria are defined as "frail", individuals meeting 1 or 2 criteria are defined as "pre-fragile (pre-fragile) and individuals who do not meet any criteria are defined as "normal or robust".
1 day
Kihon Checklist
Frailty status will determined according to the Turkish version of the Kihon Checklist (KCL) which consists of 25 questions for yes (1) or no (0) answers. KCL includes seven categories as; physical function (5 items), mood (5 items), instrumental activities of daily life (5 items), nutrition (2 items), oral function (3 items), memory (3 items) and socialization (2 items). Total KCL scores range from 0 to 25 and scores ≥8 indicate frailty, between 4 to 7 indicate pre-frailty and between 0 to 3 indicate robustness.
1 day
Short Physical Performance Battery(SPPB)
SPPB can be used to determine frailty status. It comprises 3 parameters: static balance, sit to stand test and walking speed. Scores above 9 indicates no frailty, between 7 to 9 indicates pre-frailty and below 7 indicates frailty status.
1 day
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
1 day
Bath Ankylosing Spondylitis Functional Index (BASFI)
1 day
Depression and Anxiety
1 day
Ankylosing Spondylitis Quality of Life Scale
1 day
Gait Speed
1 day
Grip Strength
1 day
Physical Activity Level
1 day
Patients diagnosed with Axial Spondyloarthritis in a tertiary research and training hospital
Haydarpaşa Numune Research and Training Hospital
Istanbul, Turkey (Türkiye)
100 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2021
First Posted
August 18, 2021
Study Start
August 12, 2021
Actual (reported)Effectıvenes Of Frail Scale And Daily Lıfe Activity Assesment For Major Abdominal Surgery Patients
Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis
Contact the study team to confirm eligibility.
Primary Completion
February 10, 2022
Actual (reported)Study Completion
February 10, 2022
Actual (reported)Last Updated
July 5, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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