Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis

Sarcopenia Clinical Trial

Official title:

Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284200
• Other study ID #: sarcopenia eRA
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: June 23, 2024

Study information

• Verified date: February 2024
• Source: Kayseri City Hospital
• Contact: HAVVA TALAY ÇALIS, PROF
• Phone: +905326874541
• Email: htalaycalis[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared. Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study.

Description:

According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who met the 2010 ACR / EULAR RA classification criteria will be included in the study. The presence of sarcopenia will be evaluated according to the European Working Group on Sarcopenia in Older People (EWGSOP-2) criteria by performing hand grip strength, muscle mass measurement with Bioelectrical Impedance Analysis (BIA), and 4-meter general walking speed tests. Demographic data of the patients and anti-nuclear antibody (ANA), rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) levels, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score ( DAS)28, functional status (health assessment questionnaire (HAQ)), quality of life (RA quality of life scale (RAQoL)), anxiety and depression (hospital anxiety and depression scale (HADS)) results will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 23, 2024
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria for the early RA group:

• To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
• Being 18 years or older
• Being followed up with a diagnosis of RA for less than 1 year (early RA)

Inclusion criteria for the RA group:

• To be diagnosed with RA according to the 2010 ACR (American Society for the Study of Rheumatism) / EULAR (European Association for the Study of Rheumatism) RA classification criteria
• Being 18 years or older

Exclusion Criteria:

• Presence of other rheumatic disease
• Presence of malnutrition
• Recent surgical history,
• Stroke history,
• Pregnancy,
• Presence of prosthesis or metal implant,
• Presence of a pacemaker,
• Patients over 140 kg

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Sarcopenia

Locations

Country	Name	City	State
Turkey	Health Sciences University, Kayseri Medicine Faculty	Kocasinan	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Muscle Mass	Muscle mass evaluations in patients will be made using the Bioelectrical Impedance Analysis (BIA) (Multi Frequency Segmental Body Composition) method. According to the data obtained from the BIA device, appendicular skeletal muscle mass index (ASMI). The ASMI cut-off point recommended by the EuropeanWorkingGroup on Sarcopenia in Older People (EWGSOP2) would be <7.26 kg/m2 for men and <5.5 kg/m2 for women. Patients with low ASMI will be evaluated as having sarcopenia.	once at the baseline
Primary	Evaluation of Muscle Strength	In general, hand grip strength is one of two methods used to measure muscle strength in patients with suspected sarcopenia. Hand grip strength is related to strength in other muscles and can therefore be used as a tool to demonstrate muscle weakness. The hydraulic hand dynamometer will be used in all patients included in this study, and measurements will be recorded in kilogram. Measurements will be made with the patient in a sitting position on a chair, with the elbow close to the body and 90 degrees of flexion, and the wrist in neutral.Patients will be asked to grasp the dynamometer as firmly as possible. Three measurements will be taken for the patients and the average was taken. The recommended cut-off point for the hand grip test will be considered to be <27 kg for men and <16 kg for women.Patients with low hand grip strength will be evaluated as having possible sarcopenia.	once at the baseline
Primary	Evaluation of Muscle Performance	Physical performance will be evaluated with a 4-meter general walking speed test. The patient will be asked to walk a distance of 4 meters at his normal pace, as in his daily life, and the time to walk the distance of 4 meters will be calculated in seconds. 4 meter general walking speed will be calculated in m/sec and speeds below 0.8 m/sec will be considered low walking speed.	once at the baseline
Secondary	Rheumatoid Arthritis Quality of Life Scale	The Turkish version of the Rheumatoid Arthritis Quality of Life Scale (RAQoL), prepared for use in the Turkish population, is valid, reliable and practical to use in clinical studies. It is recommended that the scale be used in the individual monitoring of patients with RA and in the evaluation of treatment effectiveness in clinical studies.	once at the baseline
Secondary	Health Assessment Questionnaire (HAQ)	The HAQ was developed by Fries et al. in 1980 to evaluate the physical limitations of patients with Rheumatoid Arthritis. It gauges activities of daily living consisting of 20 items in 8 sections. Each item is scored between 0-3 (0: no difficulty at all, 1: some difficulty, 2: great difficulty, 3: cannot do it at all). High score means low functionality. The scale was adapted to Turkish society.	once at the baseline
Secondary	Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression will measured by using HADS, which is a 14-item questionnaires with 7 responses each for anxiety and depression with a maximum possible score of 3 for a particular response. A score of up to 7 is considered normal, with scores of 8-10 as borderline abnormal and scores 11-21 as being abnormal.	once at the baseline