Axial SpondyloarthritisNCT06000072
Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis
A study testing Core Exercise Program in people with Axial Spondyloarthritis and Telerehabilitation, run by Acibadem University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Axial Spondyloarthritis, Telerehabilitation, Exercise
- What is being tested?
- Core Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 11 Aug 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy, malignancy, and recent surgery
- Presence of cardiopulmonary disease
- Patients with endoprosthesis and prosthesis
- Attending a regular exercise program (Pilates, core, or yoga etc.)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Haydarpasa Numune Research and Training Hospital
Istanbul, 34752
Acıbadem Mehmet Ali Aydınlar University
Istanbul
About this study
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.
- Conditions
- Axial Spondyloarthritis, Telerehabilitation, Exercise
- Being tested
- Core Exercise Program
- Medical subject headings
- Axial Spondyloarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Exercise ProgramOther
Core exercises
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Telerehabilitation sessions including core exercises Receives: Other: Core Exercise Program |
| Video-based | Active comparator | Core exercises by watching pre-recorded videos Receives: Other: Core Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary outcomes (8)
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).
Measured: 8 weeks
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).
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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).
Measured: 8 weeks
Ankylosing Spondylitis Quality of Life
The ASQoL consists of 18 questions and patients are asked to answer yes or no to each question. The total score ranges from 0-18. Higher scores indicate a poorer quality of life.
Measured: 8 weeks
Timed Up and Go Test
The patients sit on a chair and are asked to stand up and walk for 3 meters then sit again. The time to complete this task is recorded.
Measured: 8 weeks
30 Seconds 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start11 Aug 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000072
- Sponsor's protocol ID
- ATADEK 2023 - 10/341
- Status last verified
- Jul 2024
- First submitted
- 11 Aug 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sen EN, Saritas F, Ozturk O. Synchronous and asynchronous remote core stability exercises in patients with axial spondyloarthritis: a randomized-controlled clinical trial. Ir J Med Sci. 2025 Feb;194(1):137-146. doi: 10.1007/s11845-024-03846-8. Epub 2024 Nov 26.
PubMed 39589722
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT06000072
- Acronym / sponsor ID
- ATADEK 2023 - 10/341
- Conditions
- Axial Spondyloarthritis, Telerehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Core Exercise ProgramTelerehabilitation sessions including core exercises |
| Video-based | Active comparator | Other: Core Exercise ProgramCore exercises by watching pre-recorded videos |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy, malignancy, and recent surgery
- Presence of cardiopulmonary disease
- Patients with endoprosthesis and prosthesis
- Attending a regular exercise program (Pilates, core, or yoga etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Exercise ProgramCore exercises | Other | Telerehabilitation, Video-based |
Primary outcome
Core Endurance Tests : Trunk Flexion Test
Time frame: 8 weeks
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):
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
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 secondary outcomes
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 8 weeks
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 8 weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: 8 weeks
Global Rating of Change (GROC)
Time frame: 8 weeks
Pain intensity (Numeric Rating Scale/NRS)
Time frame: 8 weeks
Ankylosing Spondylitis Quality of Life
Time frame: 8 weeks
Timed Up and Go Test
Time frame: 8 weeks
30 Seconds Sit and Stand Test
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 39589722Sen EN, Saritas F, Ozturk O. Synchronous and asynchronous remote core stability exercises in patients with axial spondyloarthritis: a randomized-controlled clinical trial. Ir J Med Sci. 2025 Feb;194(1):137-146. doi: 10.1007/s11845-024-03846-8. Epub 2024 Nov 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Exercise Program in people with Axial Spondyloarthritis and Telerehabilitation, run by Acibadem University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Endurance Tests : Trunk Flexion Test (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.