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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06000072
Other study ID # ATADEK 2023 - 10/341
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2023
Est. completion date May 15, 2024

Study information

Verified date February 2024
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Exercise is a core treatment method in the management of Axial Spondyloarthritis. Clinical guidelines recommend a combination of pharmacologic and non-pharmacologic approaches to reduce disease activity and symptoms and improve physical function. The COVID-19 pandemic has accelerated the provision of healthcare services remotely and the digitalization of rehabilitation services. Telerehabilitation methods provide advantages in terms of transportation, prevention of infections that may occur due to suppression of immunity with drugs, and continuity of treatment in patients with axial spondyloarthritis. In this context, it is important to evaluate the effects of remote physiotherapy and rehabilitation delivery in chronic inflammatory rheumatic diseases. This study, which will examine the effects of telerehabilitation in the disease management processes of individuals with axial spondyloarthritis, is thought to shed light on future studies. The aim of this study was to compare the effectiveness of telerehabilitation or pre-recorded video-based core exercise program on core endurance, disease activity and physical function in subjects with axial spondyloarthritis.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 18 - 55 years old, - Axial Spondyloarthritis diagnosed by a rheumatologist, - Not having any orthopedic, neurological, or mental illness that would affect exercise, - Not using any assistive device for ambulation - People who volunteer to participate Exclusion Criteria: - Pregnancy, malignancy, and recent surgery - Presence of cardiopulmonary disease - Patients with endoprosthesis and prosthesis - Attending a regular exercise program (Pilates, core, or yoga etc.)

Study Design


Intervention

Other:
Core Exercise Program
Core exercises

Locations

Country Name City State
Turkey Acibadem Mehmet Ali Aydinlar University Istanbul
Turkey Haydarpasa Numune Research and Training Hospital Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Acibadem University Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Core Endurance Tests : Trunk Flexion Test The patient will be asked to cross his/her hands over his/her chest and positioned with the trunk in 60° flexion and knees in 90° flexion. The time in this position will be measured and recorded with a stopwatch. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated. 8 weeks
Primary Core Endurance Tests : Side Plank (Side Bridge Test): The patient will be asked to lie on his/her side on the dominant side and cross his/her foot over the other foot. The non-dominant arm will be crossed over the chest and placed over the dominant shoulder. The patient will be asked to stand on the dominant forearm and elbow. The time in this position will be measured with a cronometer and recorded. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated. 8 weeks
Primary Core Endurance Tests : Modified Plank The patient will be asked to position on his/her knees and elbows with his/her face to the floor. He/she will be fixed over his/her knees with the help of a belt and the duration of his/her stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated. 8 weeks
Primary Core Endurance Tests : Biering-Sorenson Test Patients will be positioned in a prone position with their spina iliaca anterior superior to the edge of the bed. Participants will be asked to extend their upper body straight forward from the edge of the table. They will be immobilized over their knees with the help of a belt and the time they stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated. 8 weeks
Primary Core Endurance Tests : 30 Second Sit and Stand Test The patient sits and stands for 30 s in a chair whose height is adjusted so that the knees are 90° when seated. The number of times the patient can sit and stand during this time will be calculated and recorded. 8 weeks
Secondary Bath Ankylosing Spondylitis Functional Index (BASFI) The questionnaire used to assess physical function in patients consists of 10 items related to activities of daily living. Each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible). 8 weeks
Secondary Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) The BASDAI is used to measure ankylosing spondylitis disease activity. In this index, fatigue, pain due to spinal and peripheral joint involvement, local tenderness at the sites of insertion, duration and severity of morning stiffness in the last 1 week are evaluated. It consists of a total of 6 items and each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible). 8 weeks
Secondary Bath Ankylosing Spondylitis Metrology Index (BASMI) It is an index that includes several measurements used to evaluate spinal mobility. These measurements are tragus-wall distance, lumbar lateral flexion test, Modified Schober test, intermalleolar distance. 8 weeks
Secondary Global Rating of Change (GROC) It is used to assess the patient's current health status and to calculate the difference between the initial health status. 8 weeks
Secondary Pain intensity (Numeric Rating Scale/NRS) It is a scale used to determine the severity of pain. It allows the patient to describe their pain in numbers. The scale starts with the absence of pain (0) and is expressed as unbearable pain (10 or 100). 8 weeks
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