Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis
Primary Purpose
Axial Spondyloarthritis, Telerehabilitation, Exercise
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Axial Spondyloarthritis
Eligibility Criteria
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.)
Sites / Locations
- Haydarpasa Numune Research and Training HospitalRecruiting
- Acıbadem Mehmet Ali Aydınlar UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telerehabilitation
Video-based
Arm Description
Telerehabilitation sessions including core exercises
Core exercises by watching pre-recorded videos
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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).
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).
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.
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.
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).
Full Information
NCT ID
NCT06000072
First Posted
August 11, 2023
Last Updated
August 17, 2023
Sponsor
Acibadem University
Collaborators
Haydarpasa Numune Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06000072
Brief Title
Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis
Official Title
Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
Collaborators
Haydarpasa Numune Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis, Telerehabilitation, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Telerehabilitation sessions including core exercises
Arm Title
Video-based
Arm Type
Active Comparator
Arm Description
Core exercises by watching pre-recorded videos
Intervention Type
Other
Intervention Name(s)
Core Exercise Program
Intervention Description
Core exercises
Primary Outcome Measure Information:
Title
Core Endurance Tests : Trunk Flexion Test
Description
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.
Time Frame
8 weeks
Title
Core Endurance Tests : Side Plank (Side Bridge Test):
Description
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.
Time Frame
8 weeks
Title
Core Endurance Tests : Modified Plank
Description
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.
Time Frame
8 weeks
Title
Core Endurance Tests : Biering-Sorenson Test
Description
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.
Time Frame
8 weeks
Title
Core Endurance Tests : 30 Second Sit and Stand Test
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
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).
Time Frame
8 weeks
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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).
Time Frame
8 weeks
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Description
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.
Time Frame
8 weeks
Title
Global Rating of Change (GROC)
Description
It is used to assess the patient's current health status and to calculate the difference between the initial health status.
Time Frame
8 weeks
Title
Pain intensity (Numeric Rating Scale/NRS)
Description
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).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Haydarpasa Numune Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Sarıtaş, MD
Phone
5337707679
Email
fatihsaritas@yahoo.com
Facility Name
Acıbadem Mehmet Ali Aydınlar University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özgül Öztürk, PhD
Phone
2165004185
Email
ozgul.ozturk@acibadem.edu.tr
First Name & Middle Initial & Last Name & Degree
Ece Nur Şen
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis
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