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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010720
• Other study ID #: ATADEK 2021/14
• Status: Completed
• Start date: August 12, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: June 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Frailty
• Spondylarthritis
• Spondylitis

Locations

Country	Name	City	State
Turkey	Haydarpasa Numune Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait Speed	The patient will be asked to walk 4 meter distance in a normal gait speed for two times. The shortest time will be recorded.	1 day
Other	Grip Strength	Grip 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.	1 day
Other	Physical Activity Level	The 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.	1 day
Primary	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
Primary	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
Primary	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	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	BASDAI 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.	1 day
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI)	BASFI 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.	1 day
Secondary	Depression and Anxiety	Depression 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.	1 day
Secondary	Ankylosing Spondylitis Quality of Life Scale	The 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.	1 day