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Prevelance of Frailty and Its Associated Factors in Patients With Axial Spondyloarthritis

Prevelance of Frailty and Its Associated Factors in Patients With Axial Spondyloarthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05010720
Enrollment
100
Registered
2021-08-18
Start date
2021-08-12
Completion date
2022-02-10
Last updated
2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis, Frailty

Brief summary

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.

Interventions

None listed

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist. * To be between the ages of 40-65

Exclusion criteria

* Severe comorbidities such as cancer and stroke * Being diagnosed with newly defined or recurrent cancer, * Not having enough cognitive skills to answer the questions, * Having neurological problems such as stroke * Having cognitive impariment

Design outcomes

Primary

MeasureTime frameDescription
Kihon Checklist1 dayFrailty 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.
Fried Frailty Phenotype1 dayThe 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.
Short Physical Performance Battery(SPPB)1 daySPPB 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.

Secondary

MeasureTime frameDescription
Ankylosing Spondylitis Quality of Life Scale1 dayThe Turkish version of the Ankylosing Spondylitis Quality of Life (ASQOL) scale will be used to assess disease-related quality of life. ASQOL includes 18 items with dichotomous responses (yes/no) evaluating the impact of disease on social life, sleep, motivation, mood, coping, independence and activities of daily living, The score ranges between 0 to 18 and higher score indicates reduced quality of life.
Depression and Anxiety1 dayDepression and anxiety status of the included patients will be evaluated with the Turkish version of the Hospital Anxiety and Depression Scale (HADS). This scale consists of 14 items; 7 for depression symptoms and 7 for anxiety symptoms. Each answer is scored 0 to 3. Cut-off values for the Turkish version are 7 and 10 for depression and anxiety subscales, respectively.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)1 dayBASDAI evaluates disease-specific symptoms such as fatigue, joint pain, and morning stiffness in individuals with Ankylosing Spondylitis between 0 and 10. A high score is expressed by an increase in disease activity.
Bath Ankylosing Spondylitis Functional Index (BASFI)1 dayBASFI has been developed to determine the functional status of individuals with Ankylosing Spondylitis and evaluates the perceived stress level in daily activities between 0 and 10 (0 = easy and 10 = impossible). Activities such as bending, reaching, standing, changing positions, climbing stairs are questioned. The total score is determined by dividing the sum of the scores from each item by 10, and 0 is defined as the best score and 10 as the worst score.

Other

MeasureTime frameDescription
Gait Speed1 dayThe patient will be asked to walk 4 meter distance in a normal gait speed for two times. The shortest time will be recorded.
Physical Activity Level1 dayThe physical activity level reported by the participants will be evaluated with the International Physical Activity Questionnaire - Short Form. The International Physical Activity Questionnaire - Short Form questions the time to spent in walking, moderate and vigorous activities, and sitting with 7 questions. The duration (minutes) and frequency (days) of each activity are questioned. According to the survey results, the physical activity levels of the participants will be classified as inactive, minimally active and very active.
Grip Strength1 dayGrip strength will be evaluated with JAMAR dynamometer. The patient will be positioned in a chair with the elbow flexed to 90 degrees and the wrist in a neutral position, and he/she will be asked to grip as strong as he/she can do for 3 seconds. The test will be repeated 3 times and the highest value will be recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026