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

NCT05010720 | Completed

• 1 other identifier: ATADEK 2021/14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• 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

Other Outcomes (3)

• Gait Speed

  1 day

• Grip Strength

  1 day

• Physical Activity Level

  1 day

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with Axial Spondyloarthritis in a tertiary research and training hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Haydarpaşa Numune Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 18, 2021
• Study Start: August 12, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

TU (1)