Anklyosing SpondylitisNCT07503327
Effectiveness of Telerehabilitation in Ankylosing Spondylitis
A study testing Synchronous Telerehabilitation Exercise Program, Asynchronous Telerehabilitation Exercise Program and Brochure Program in people with Anklyosing Spondylitis and Telerehabilitation, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the study: Ankylosing spondylitis (AS) is a chronic disease that affects the spine and joints, causing pain, stiffness, fatigue, and reduced quality of life. Exercise is known to help reduce pain and improve function in individuals with AS. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Anklyosing Spondylitis, Telerehabilitation
- What is being tested?
- Synchronous Telerehabilitation Exercise Program, Asynchronous Telerehabilitation Exercise Program and Brochure Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Having been diagnosed with Ankylosing Spondylitis by a specialist at least one year ago,
- Agreeing to participate in the study voluntarily,
- Owning and being able to use a smartphone,
- Being able to read and write.
Who cannot join
- Having a history of pregnancy, malignancy, or recent surgery (within the last six months)
- Having a history of hypertension and diabetes that cannot be controlled with medication
- Having a history of exacerbations in the last three weeks and having received treatment for exacerbations
- Having instable medical treatment within the last three months
- Having any orthopedic, neurological, or mental illness that would affect exercise
- Having any assistive device for ambulation
Show all 10Show fewer
- Having participated in any exercise-based intervention program within the last month Exclusion Criteria
- Failure to attend three consecutive treatment sessions,
- Failure to complete the tests and questionnaires,
- Voluntarily withdrawing from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fırat University Faculty of Medicine, Department of Internal Medicine - Division of Rheumatology.
Elâzığ
Fırat University Faculty of Medicine Department of Internal Medicine - Division of Rheumatology., 090424-233-3555, hastane@firat.edu.tr
About this study
Official title: Investigation of the Effectiveness of Different Telerehabilitation Applications in Patients With Ankylosing Spondylitis
Purpose of the study:
Ankylosing spondylitis (AS) is a chronic disease that affects the spine and joints, causing pain, stiffness, fatigue, and reduced quality of life. Exercise is known to help reduce pain and improve function in individuals with AS. However, the most effective type and method of exercise are not fully known. This study aims to compare the effects of different telerehabilitation methods-synchronous (live video) and asynchronous (pre-recorded video)-on disease activity, physical function, mobility, fatigue, quality of life, kinesiophobia (fear of movement), and pain levels in individuals with AS.
Read more
Study design and methods:
This is a randomized controlled experimental study. Participants will be randomly assigned to one of three groups:
Synchronous telerehabilitation: Exercise sessions via live video, 3 times per week for 8 weeks.
Asynchronous telerehabilitation: Exercise sessions via pre-recorded videos, 3 times per week for 8 weeks.
Control group: Exercise instructions provided in a brochure.
All groups will perform exercises for approximately 40-50 minutes per session, focusing on flexibility, strength, posture, balance, coordination, and functional movements. Participants will be evaluated before the intervention (week 0) and after 8 weeks for disease activity, physical function, mobility, fatigue, quality of life, kinesiophobia, and pain during rest, movement, and sleep.
Participants:
The study will include adults aged 18-65 years diagnosed with AS at least one year prior, able to use a smartphone, and willing to participate. Individuals who are pregnant, have serious comorbidities, recent surgery, or conditions affecting mobility will be excluded.
Expected benefits:
The study will identify which telerehabilitation method is more effective for individuals with AS. telerehabilitation may provide easier access to treatment, improve adherence to exercise programs, and contribute to better disease management and quality of life.
Read the detailed description
Ankylosing spondylitis (AS) is an autoimmune musculoskeletal disease characterized by axial joint involvement. AS, which belongs to the spondyloarthritis (SpA) group, primarily affects the sacroiliac joints but can also involve the spine, peripheral joints, and ligaments; extra-articular manifestations may include ocular, cardiac, renal, neurological, and psychiatric involvement. AS is associated with conditions such as depression, anxiety, chronic fatigue, disease activity, and overall health status. Therefore, assessing these factors is necessary as part of a comprehensive management approach in individuals with AS. Another important parameter affected in individuals with AS is mobility. The BASMI score, a mobility assessment tool including cervical rotation, tragus-to-wall distance, lateral trunk flexion, lumbar flexion, and intermalleolar distance measurements, affects both sexes, although the level of impact may differ by sex.
Exercise programs in individuals with AS are used to reduce pain and improve function. Although exercise is known to be beneficial for individuals with AS, there is insufficient knowledge regarding the type and dose of exercise that provides maximum benefit. Generally, exercise prescriptions for these individuals are determined based on clinical experience. It is known that any exercise program, regardless of type, has a positive effect on function in individuals with AS. Exercise programs that include flexibility and strengthening exercises have a particularly strong impact on mobility. Therefore, incorporating these exercises into exercise programs should be encouraged. Additionally, strengthening, stretching/flexibility, and respiratory exercises are beneficial for individuals with AS and should be included in exercise programs.
AS usually begins in early adulthood and affects a person's daily activities throughout life. The goals are to alleviate symptoms, control inflammation, and improve health-related quality of life to prevent disease progression. In this context, patient education and exercise programs are important. To support these parameters, the use of current technological approaches is recommended. One of the technological approaches used in our study is telerehabilitation (TR), which represents one of these contemporary strategies.
Evidence regarding the usefulness of telemedicine and digital health in the management and monitoring of rheumatic and musculoskeletal diseases is steadily increasing. Numerous digital tools effectively measure clinical, humanistic, and patient-reported outcomes in rheumatology and musculoskeletal diseases. Integrating various digital tools in rheumatology is challenging but promising. Moreover, telemedicine should focus on developing standardized recommendations for practical use in daily practice. Advancements in telemedicine in rheumatology facilitate the provision of services such as prevention, diagnosis, treatment, rehabilitation, and follow-up, reducing the burden of disease for patients and caregivers; however, certain aspects still need further clarification.
Telehealth systems are generally classified into four technical categories: synchronous, asynchronous, remote monitoring, and mobile health. Synchronous methods involve real-time communication between the healthcare professional and the patient, usually through live video sessions. Asynchronous methods involve non-live interactions, where pre-recorded videos are shared. Remote monitoring allows patients' health data to be collected through technological devices and monitored remotely by healthcare professionals. Mobile health includes services such as accessing health information and tracking exercises via mobile applications and devices. These four approaches provide individuals with flexible healthcare services that save both time and costs.
Factors such as increasing population, rising costs, crowded hospital appointments, and transportation difficulties can limit access to rehabilitation services. As a solution, alternative rehabilitation approaches are needed for individuals with AS. TR is an effective approach that facilitates access to healthcare, enables patients to exercise regularly at home, allows remote monitoring, and supports treatment continuity. TR also offers broader access to physiotherapy and cost advantages. Therefore, determining the most suitable application method for the patient is of great importance.
In our study, there are two intervention groups based on tele-rehabilitation methods: synchronous and asynchronous applications. A third group, the control group, will receive exercise education only through brochures. Providing education via written materials, such as brochures, is considered an important supportive element alongside non-pharmacological treatment methods in individuals with AS, and has been reported to have positive effects on disease outcomes. A study comparing synchronous and asynchronous core stability exercises in patients with axial spondyloarthritis reported that synchronous training may yield better results than asynchronous training.
Access to out-of-hospital healthcare is particularly important in the management of chronic diseases such as AS. In this context, remote rehabilitation methods such as TR support patients' regular participation in treatment and facilitate disease management. TR enables patients to access healthcare from their location while providing advantages in cost-effectiveness and time management. Therefore, the wider use of TR in the healthcare system for chronic conditions such as AS may contribute to the inclusion of patients in a sustainable, lifelong rehabilitation process. Exercise is also expected to help control symptoms, reduce medication use, and thereby decrease the frequency of outpatient visits. Furthermore, especially in the aftermath of population displacement following earthquakes, it is possible to provide rehabilitation services to individuals with limited access to healthcare and ensure continuity.
Study Type This study is designed as a randomized controlled experimental study.
Study Material The study will be conducted between August 2025 and December 2026 with patients diagnosed with ankylosing spondylitis (AS). The study materials are described in the data collection tools section.
Data Collection Tools
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Tampa Scale of Kinesiophobia (TSK)
Visual Analog Scale (VAS)
Disease activity will be measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Functional status will be evaluated using the Bath Ankylosing Spondylitis Functional Index (BASFI). Mobility will be assessed using the Bath Ankylosing Spondylitis Metrology Index (BASMI). Fatigue level will be evaluated using the fatigue item of BASDAI. Quality of life will be assessed using the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK). Pain levels at rest, during movement, and while sleeping will be assessed using the VAS score.
BASDAI: Developed by Garrett et al., BASDAI is an AS-specific index that measures disease activity. Scores range from 0 to 10, with higher scores indicating increased disease activity. The fatigue item of BASDAI will also be used to assess fatigue.
BASFI: Developed by Calin et al., BASFI assesses functionality in patients with AS. The index consists of 10 questions scored from 0 to 10. Total scores are summed and divided by 10 to obtain the final score.
BASMI: This index evaluates mobility in individuals with AS, including cervical rotation, tragus-to-wall distance, lumbar flexion, lateral trunk flexion, and intermalleolar distance measurements. The BASMI index, developed by Zochling, reflects movement limitations and disease progression in AS, with higher scores indicating greater mobility restriction.
ASQoL: Developed by Doward et al., the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) consists of 18 items designed to assess the quality of life in patients with AS.The validity and reliability of the Turkish version were established by Duruöz et al. Each item is answered as "yes" (1) or "no" (0), with higher total scores indicating poorer quality of life.
Tampa Scale of Kinesiophobia (TSK): Developed by Vlaeyen et al., this 17-item scale assesses fear of movement and re-injury. The Turkish version was validated by Yılmaz et al. . Items are scored from 0 to 4, with reverse scoring applied to items 4, 8, 12, and 16. Total scores range from 17 to 68, with higher scores indicating greater kinesiophobia Research Variables
Dependent variables: Disease activity, functionality, mobility, fatigue level, quality of life, kinesiophobia, pain at rest, during movement, and during sleep
Independent variables: Telerehabilitation method (synchronous TR, asynchronous TR, control group)
Control variables: Age, sex, income level
Study Plan
Study Design All participants will undergo assessments at two time points: pre-intervention (week 0) and post-intervention (week 8). After the pre-test assessments, participants will be informed about their assigned groups and begin the corresponding rehabilitation program. The control group will receive the same exercise protocol as the TR groups, formatted as a brochure with photos and explanations. Exercises in all three groups will be initiated at an appropriate difficulty level according to the patient's condition and progressed every two weeks. Progression will involve increasing repetitions, sets, or exercise difficulty. Each session will last approximately 40-50 minutes, and patients will be contacted biweekly to provide verbal feedback on challenging exercises. Participants will be asked to perform the program three times per week for eight weeks
Interventions
Synchronous Telerehabilitation Group:
Patients in this group will perform exercise sessions via live video calls (WhatsApp) three times per week for a total of 8 weeks. Each session will last approximately 40-50 minutes.
Asynchronous Telerehabilitation Group:
Exercise videos will be sent to this group every two weeks via WhatsApp. Feedback on patients' exercise performance will be obtained via messages or phone calls. Sessions will also be performed three times per week for eight weeks. Patients will maintain an exercise log to allow objective monitoring of adherence.
Control Group:
Participants in the control group will receive the same exercise protocol used in the TR groups as a photo-and-description brochure. The brochure content will be updated every two weeks, and patients will be asked to perform exercises three times per week for eight weeks. An exercise log will also be provided to allow objective tracking.
Randomization Participants who meet the inclusion criteria and provide informed consent will be randomized into three groups (synchronous TR, asynchronous TR, and control) after pre-assessment. Randomization will ensure equal numbers of participants per group based on the predetermined total sample size. A list of 22 participants per group (total 66) will be generated, and https://www.random.org/lists/ will be used to randomize the group order. The randomized sequence will be recorded as the randomization schedule. As participants are enrolled, they will be assigned to groups according to the schedule and informed about the intervention protocol. This method ensures objective allocation and balance across groups.
Exercise Protocol Participants will perform strengthening, stretching, balance, coordination, posture, walking, and functional exercises in different positions (prone, sitting, standing). To facilitate the exercises, the program will start with prone and supine positions and progress to sitting and vertical positions. Each session will begin with warm-up exercises and end with cool-down exercises.
Statistical Methods
The sample size of this study was determined using a power analysis. Data analyses will be performed using the Statistical Package for the Social Sciences version 25 (SPSS). The normality of the data will be evaluated both visually (histograms and probability plots) and analytically using the Shapiro-Wilk Test.
For continuous variables, results will be presented as mean ± standard deviation (X±SD).
For categorical variables, results will be expressed as frequency (n) and percentage (%).
The Pearson Chi-Square test will be used to evaluate categorical variables.
For comparisons between two independent groups, the significance of differences between means will be assessed using the Two Independent Samples t-test or the Mann-Whitney U test, depending on the normality assumption. For comparisons between two dependent groups, the Two Paired Samples t-test or the Wilcoxon Signed-Rank Test will be used. To test differences among groups in repeated measures, Repeated Measures ANOVA will be applied. A significance level of p < 0.05 will be considered statistically significant.
Power Analysis
Population and Sample The sample size of this study was determined using a power analysis. Calculations were performed using G*Power 3.1.9.7. Considering the study design with three groups (Synchronous TR, Asynchronous TR, and Control Group), tests comparing more than two independent groups were planned to evaluate differences between variables. A large effect size (0.40) was assumed. Based on this calculation, a total of 66 participants (22 per group) will provide a statistical power of 81.8% at a significance level of 0.05. Since this power exceeds 80%, the sample size is considered sufficient. Participants will be recruited from individuals aged 18-65 diagnosed with AS who attend the Department of Internal Medicine, Division of Rheumatology at Fırat University Hospital.
- Conditions
- Anklyosing Spondylitis, Telerehabilitation
- Being tested
- Synchronous Telerehabilitation Exercise Program, Asynchronous Telerehabilitation Exercise Program, Brochure Program
- Keywords
- Spondylitis, Ankylosing, Telemedicine, Rehabilitation, Mobility Limitation
- Medical subject headings
- Spondylitis, Ankylosing, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous Telerehabilitation Exercise ProgramBehavioural
Participants receive supervised synchronous telerehabilitation via video calls (WhatsApp) three times per week for 8 weeks. Each session lasts 40-50 minutes and includes mobility and exercise training under live supervision.
Asynchronous Telerehabilitation Exercise ProgramBehavioural
Participants receive asynchronous telerehabilitation with exercise videos sent every 2 weeks via WhatsApp. Exercises are performed 3 times per week for 8 weeks. Feedback is provided by message or phone call, and participants keep an exercise diary for adherence tracking.
Brochure ProgramBehavioural
Participants receive a printed exercise brochure containing the same program as the intervention groups, updated every 2 weeks. They are asked to perform the exercises 3 times per week for 8 weeks and keep an exercise diary for adherence tracking.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Telerehabilitation Group | Experimental | Participants will receive synchronous telerehabilitation via video calls (WhatsApp) 3 times per week for 8 weeks. Each session will last 40-50 minutes and include prescribed exercise programs under live supervision. Receives: Behavioral: Synchronous Telerehabilitation Exercise Program |
| Asynchronous Telerehabilitation Group | Experimental | Participants will receive asynchronous telerehabilitation with exercise videos delivered every 2 weeks via WhatsApp. Exercises will be performed 3 times per week for 8 weeks with feedback provided by message or phone call. An exercise diary will be used to monitor adherence. Receives: Behavioral: Asynchronous Telerehabilitation Exercise Program |
| Control Group | Active comparator | Participants will receive a printed exercise brochure containing the same program as the intervention groups, updated every 2 weeks. They will be asked to perform the exercises 3 times per week for 8 weeks. An exercise diary will be used to monitor adherence. Receives: Behavioral: Brochure Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cervical rotation (degrees) from baseline to 8 weeks
Cervical rotation is measured in degrees using a goniometer to assess mobility in individuals with Ankylosing Spondylitis. The mean value of left and right cervical rotation measurements for each participant will be recorded at baseline and at 8 weeks, and the change from baseline to 8 weeks will be reported.
Measured: 8 weeks
Change from baseline in Tampa Scale of Kinesiophobia (TSK)
Change from baseline in Tampa Scale of Kinesiophobia (TSK) after 8 weeks. TSK is scored from 17 to 68, with higher scores indicating greater fear of movement/kinesiophobia.
Measured: 8 weeks
Change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scale after 8 weeks. ASQoL is scored from 0 to 18, with higher scores indicating worse quality of life.
Measured: 8 weeks
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a validated questionnaire assessing functional ability in patients with ankylosing spondylitis. It consists of 10 items scored on a 0-10 scale. The mean of the 10 items will be used to calculate a total BASFI score (range 0-10), with higher scores indicating greater functional limitation.
Measured: 8 weeks
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI is a validated index used to determine disease activity in individuals with ankylosing spondylitis. It consists of six questions assessing fatigue, spinal pain, joint pain/swelling, enthesitis, and duration and severity of morning stiffness. Each question is scored on a 0-10 numerical rating scale, and the total BASDAI score is calculated as the mean of these values (range 0-10). Higher scores indicate greater disease activity.
Measured: 8 weeks
Change in Visual Analog Scale (VAS) pain score at rest from baseline after 8 weeks
Pain intensity at rest will be evaluated using a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Measured: 8 weeks
Change in Visual Analog Scale (VAS) pain score during movement from baseline after 8 weeks
Pain intensity during movement will be evaluated using a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Measured: 8 weeks
Change in Visual Analog Scale (VAS) pain score during sleep from baseline after 8 weeks
Pain intensity during sleep will be evaluated using a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Measured: 8 weeks
Change in tragus-to-wall distance (cm) from baseline to 8 weeks
Tragus-to-wall distance is measured in centimeters as part of spinal mobility assessment in individuals with Ankylosing Spondylitis. The mean of left and right tragus-to-wall measurements for each participant will be recorded at baseline and at 8 weeks, and the change from baseline to 8 weeks will be reported.
Measured: 8 weeks
Change in lumbar side flexion (cm) from baseline to 8 weeks
Lumbar side flexion is measured in centimeters to assess lateral mobility of the lumbar spine. The mean of left and right measurements for each participant will be recorded at baseline and at 8 weeks, and the change from baseline to 8 weeks will be reported.
Measured: 8 weeks
Change in lumbar flexion (Modified Schober's test, cm) from baseline to 8 weeks
Lumbar flexion is measured in centimeters using the Modified Schober's test to assess forward mobility of the lumbar spine. Each participant's measurements at baseline and at 8 weeks will be recorded, and the change from baseline to 8 weeks will be reported.
Measured: 8 weeks
Change in intermalleolar distance (cm) from baseline to 8 weeks
Intermalleolar distance is measured in centimeters to assess hip mobility in individuals with Ankylosing Spondylitis. Each participant's measurements at baseline and at 8 weeks will be recorded, and the change from baseline to 8 weeks will be reported.
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 posted31 Mar 2026
- Study start1 Aug 2025
- Primary completionApr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anklyosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Model description
- This is a randomized, parallel-group, interventional study designed to compare the effects of synchronous and asynchronous telerehabilitation programs on disease activity, function, mobility, fatigue, quality of life, kinesiophobia, and pain scores in individuals with ankylosing spondylitis. Participants are randomly assigned to one of three arms (synchronous telerehabilitation, asynchronous telerehabilitation, control) and will undergo an 8-week exercise program performed three times per week.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Firat University
- Responsible party
- Principal investigator, Betul Ergun, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503327
- Sponsor's protocol ID
- AS- Telerehabilitation
- Status last verified
- Mar 2026
- First submitted
- 18 Sep 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan Description: De-identified individual participant data (IPD) collected in this study, including BASFI, BASDAI, BASMI, ASQoL, TSK, and VAS scores, will not be shared outside the research team due to patient confidentiality and ethical restrictions. Access Criteria: Data will only be available to the investigators of this study. Requests from external researchers cannot be accommodated. Available IPD/Information: Not applicable.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Different Telerehabilitation Applications in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07503327
- Acronym / sponsor ID
- AS- Telerehabilitation
- Conditions
- Anklyosing Spondylitis, Telerehabilitation
- Keywords
- Spondylitis, Ankylosing, Telemedicine, Rehabilitation, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Firat University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Mar 2026 (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.
Purpose of the study:
Ankylosing spondylitis (AS) is a chronic disease that affects the spine and joints, causing pain, stiffness, fatigue, and reduced quality of life. Exercise is known to help reduce pain and improve function in individuals with AS. However, the most effective type and method of exercise are not fully known. This study aims to compare the effects of different telerehabilitation methods-synchronous (live video) and asynchronous (pre-recorded video)-on disease activity, physical function, mobility, fatigue, quality of life, kinesiophobia (fear of movement), and pain levels in individuals with AS.
Study design and methods:
This is a randomized controlled experimental study. Participants will be randomly assigned to one of three groups:
Synchronous telerehabilitation: Exercise sessions via live video, 3 times per week for 8 weeks.
Asynchronous telerehabilitation: Exercise sessions via pre-recorded videos, 3 times per week for 8 weeks.
Control group: Exercise instructions provided in a brochure.
All groups will perform exercises for approximately 40-50 minutes per session, focusing on flexibility, strength, posture, balance, coordination, and functional movements. Participants will be evaluated before the intervention (week 0) and after 8 weeks for disease activity, physical function, mobility, fatigue, quality of life, kinesiophobia, and pain during rest, movement, and sleep.
Participants:
The study will include adults aged 18-65 years diagnosed with AS at least one year prior, able to use a smartphone, and willing to participate. Individuals who are pregnant, have serious comorbidities, recent surgery, or conditions affecting mobility will be excluded.
Expected benefits:
The study will identify which telerehabilitation method is more effective for individuals with AS. telerehabilitation may provide easier access to treatment, improve adherence to exercise programs, and contribute to better disease management and quality of life.
Detailed description
Ankylosing spondylitis (AS) is an autoimmune musculoskeletal disease characterized by axial joint involvement. AS, which belongs to the spondyloarthritis (SpA) group, primarily affects the sacroiliac joints but can also involve the spine, peripheral joints, and ligaments; extra-articular manifestations may include ocular, cardiac, renal, neurological, and psychiatric involvement. AS is associated with conditions such as depression, anxiety, chronic fatigue, disease activity, and overall health status. Therefore, assessing these factors is necessary as part of a comprehensive management approach in individuals with AS. Another important parameter affected in individuals with AS is mobility. The BASMI score, a mobility assessment tool including cervical rotation, tragus-to-wall distance, lateral trunk flexion, lumbar flexion, and intermalleolar distance measurements, affects both sexes, although the level of impact may differ by sex.
Exercise programs in individuals with AS are used to reduce pain and improve function. Although exercise is known to be beneficial for individuals with AS, there is insufficient knowledge regarding the type and dose of exercise that provides maximum benefit. Generally, exercise prescriptions for these individuals are determined based on clinical experience. It is known that any exercise program, regardless of type, has a positive effect on function in individuals with AS. Exercise programs that include flexibility and strengthening exercises have a particularly strong impact on mobility. Therefore, incorporating these exercises into exercise programs should be encouraged. Additionally, strengthening, stretching/flexibility, and respiratory exercises are beneficial for individuals with AS and should be included in exercise programs.
AS usually begins in early adulthood and affects a person's daily activities throughout life. The goals are to alleviate symptoms, control inflammation, and improve health-related quality of life to prevent disease progression. In this context, patient education and exercise programs are important. To support these parameters, the use of current technological approaches is recommended. One of the technological approaches used in our study is telerehabilitation (TR), which represents one of these contemporary strategies.
Evidence regarding the usefulness of telemedicine and digital health in the management and monitoring of rheumatic and musculoskeletal diseases is steadily increasing. Numerous digital tools effectively measure clinical, humanistic, and patient-reported outcomes in rheumatology and musculoskeletal diseases. Integrating various digital tools in rheumatology is challenging but promising. Moreover, telemedicine should focus on developing standardized recommendations for practical use in daily practice. Advancements in telemedicine in rheumatology facilitate the provision of services such as prevention, diagnosis, treatment, rehabilitation, and follow-up, reducing the burden of disease for patients and caregivers; however, certain aspects still need further clarification.
Telehealth systems are generally classified into four technical categories: synchronous, asynchronous, remote monitoring, and mobile health. Synchronous methods involve real-time communication between the healthcare professional and the patient, usually through live video sessions. Asynchronous methods involve non-live interactions, where pre-recorded videos are shared. Remote monitoring allows patients' health data to be collected through technological devices and monitored remotely by healthcare professionals. Mobile health includes services such as accessing health information and tracking exercises via mobile applications and devices. These four approaches provide individuals with flexible healthcare services that save both time and costs.
Factors such as increasing population, rising costs, crowded hospital appointments, and transportation difficulties can limit access to rehabilitation services. As a solution, alternative rehabilitation approaches are needed for individuals with AS. TR is an effective approach that facilitates access to healthcare, enables patients to exercise regularly at home, allows remote monitoring, and supports treatment continuity. TR also offers broader access to physiotherapy and cost advantages. Therefore, determining the most suitable application method for the patient is of great importance.
In our study, there are two intervention groups based on tele-rehabilitation methods: synchronous and asynchronous applications. A third group, the control group, will receive exercise education only through brochures. Providing education via written materials, such as brochures, is considered an important supportive element alongside non-pharmacological treatment methods in individuals with AS, and has been reported to have positive effects on disease outcomes. A study comparing synchronous and asynchronous core stability exercises in patients with axial spondyloarthritis reported that synchronous training may yield better results than asynchronous training.
Access to out-of-hospital healthcare is particularly important in the management of chronic diseases such as AS. In this context, remote rehabilitation methods such as TR support patients' regular participation in treatment and facilitate disease management. TR enables patients to access healthcare from their location while providing advantages in cost-effectiveness and time management. Therefore, the wider use of TR in the healthcare system for chronic conditions such as AS may contribute to the inclusion of patients in a sustainable, lifelong rehabilitation process. Exercise is also expected to help control symptoms, reduce medication use, and thereby decrease the frequency of outpatient visits. Furthermore, especially in the aftermath of population displacement following earthquakes, it is possible to provide rehabilitation services to individuals with limited access to healthcare and ensure continuity.
Study Type This study is designed as a randomized controlled experimental study.
Study Material The study will be conducted between August 2025 and December 2026 with patients diagnosed with ankylosing spondylitis (AS). The study materials are described in the data collection tools section.
Data Collection Tools
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Tampa Scale of Kinesiophobia (TSK)
Visual Analog Scale (VAS)
Disease activity will be measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Functional status will be evaluated using the Bath Ankylosing Spondylitis Functional Index (BASFI). Mobility will be assessed using the Bath Ankylosing Spondylitis Metrology Index (BASMI). Fatigue level will be evaluated using the fatigue item of BASDAI. Quality of life will be assessed using the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia (TSK). Pain levels at rest, during movement, and while sleeping will be assessed using the VAS score.
BASDAI: Developed by Garrett et al., BASDAI is an AS-specific index that measures disease activity. Scores range from 0 to 10, with higher scores indicating increased disease activity. The fatigue item of BASDAI will also be used to assess fatigue.
BASFI: Developed by Calin et al., BASFI assesses functionality in patients with AS. The index consists of 10 questions scored from 0 to 10. Total scores are summed and divided by 10 to obtain the final score.
BASMI: This index evaluates mobility in individuals with AS, including cervical rotation, tragus-to-wall distance, lumbar flexion, lateral trunk flexion, and intermalleolar distance measurements. The BASMI index, developed by Zochling, reflects movement limitations and disease progression in AS, with higher scores indicating greater mobility restriction.
ASQoL: Developed by Doward et al., the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) consists of 18 items designed to assess the quality of life in patients with AS.The validity and reliability of the Turkish version were established by Duruöz et al. Each item is answered as "yes" (1) or "no" (0), with higher total scores indicating poorer quality of life.
Tampa Scale of Kinesiophobia (TSK): Developed by Vlaeyen et al., this 17-item scale assesses fear of movement and re-injury. The Turkish version was validated by Yılmaz et al. . Items are scored from 0 to 4, with reverse scoring applied to items 4, 8, 12, and 16. Total scores range from 17 to 68, with higher scores indicating greater kinesiophobia Research Variables
Dependent variables: Disease activity, functionality, mobility, fatigue level, quality of life, kinesiophobia, pain at rest, during movement, and during sleep
Independent variables: Telerehabilitation method (synchronous TR, asynchronous TR, control group)
Control variables: Age, sex, income level
Study Plan
Study Design All participants will undergo assessments at two time points: pre-intervention (week 0) and post-intervention (week 8). After the pre-test assessments, participants will be informed about their assigned groups and begin the corresponding rehabilitation program. The control group will receive the same exercise protocol as the TR groups, formatted as a brochure with photos and explanations. Exercises in all three groups will be initiated at an appropriate difficulty level according to the patient's condition and progressed every two weeks. Progression will involve increasing repetitions, sets, or exercise difficulty. Each session will last approximately 40-50 minutes, and patients will be contacted biweekly to provide verbal feedback on challenging exercises. Participants will be asked to perform the program three times per week for eight weeks
Interventions
Synchronous Telerehabilitation Group:
Patients in this group will perform exercise sessions via live video calls (WhatsApp) three times per week for a total of 8 weeks. Each session will last approximately 40-50 minutes.
Asynchronous Telerehabilitation Group:
Exercise videos will be sent to this group every two weeks via WhatsApp. Feedback on patients' exercise performance will be obtained via messages or phone calls. Sessions will also be performed three times per week for eight weeks. Patients will maintain an exercise log to allow objective monitoring of adherence.
Control Group:
Participants in the control group will receive the same exercise protocol used in the TR groups as a photo-and-description brochure. The brochure content will be updated every two weeks, and patients will be asked to perform exercises three times per week for eight weeks. An exercise log will also be provided to allow objective tracking.
Randomization Participants who meet the inclusion criteria and provide informed consent will be randomized into three groups (synchronous TR, asynchronous TR, and control) after pre-assessment. Randomization will ensure equal numbers of participants per group based on the predetermined total sample size. A list of 22 participants per group (total 66) will be generated, and https://www.random.org/lists/ will be used to randomize the group order. The randomized sequence will be recorded as the randomization schedule. As participants are enrolled, they will be assigned to groups according to the schedule and informed about the intervention protocol. This method ensures objective allocation and balance across groups.
Exercise Protocol Participants will perform strengthening, stretching, balance, coordination, posture, walking, and functional exercises in different positions (prone, sitting, standing). To facilitate the exercises, the program will start with prone and supine positions and progress to sitting and vertical positions. Each session will begin with warm-up exercises and end with cool-down exercises.
Statistical Methods
The sample size of this study was determined using a power analysis. Data analyses will be performed using the Statistical Package for the Social Sciences version 25 (SPSS). The normality of the data will be evaluated both visually (histograms and probability plots) and analytically using the Shapiro-Wilk Test.
For continuous variables, results will be presented as mean ± standard deviation (X±SD).
For categorical variables, results will be expressed as frequency (n) and percentage (%).
The Pearson Chi-Square test will be used to evaluate categorical variables.
For comparisons between two independent groups, the significance of differences between means will be assessed using the Two Independent Samples t-test or the Mann-Whitney U test, depending on the normality assumption. For comparisons between two dependent groups, the Two Paired Samples t-test or the Wilcoxon Signed-Rank Test will be used. To test differences among groups in repeated measures, Repeated Measures ANOVA will be applied. A significance level of p < 0.05 will be considered statistically significant.
Power Analysis
Population and Sample The sample size of this study was determined using a power analysis. Calculations were performed using G*Power 3.1.9.7. Considering the study design with three groups (Synchronous TR, Asynchronous TR, and Control Group), tests comparing more than two independent groups were planned to evaluate differences between variables. A large effect size (0.40) was assumed. Based on this calculation, a total of 66 participants (22 per group) will provide a statistical power of 81.8% at a significance level of 0.05. Since this power exceeds 80%, the sample size is considered sufficient. Participants will be recruited from individuals aged 18-65 diagnosed with AS who attend the Department of Internal Medicine, Division of Rheumatology at Fırat University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized, parallel-group, interventional study designed to compare the effects of synchronous and asynchronous telerehabilitation programs on disease activity, function, mobility, fatigue, quality of life, kinesiophobia, and pain scores in individuals with ankylosing spondylitis. Participants are randomly assigned to one of three arms (synchronous telerehabilitation, asynchronous telerehabilitation, control) and will undergo an 8-week exercise program performed three times per week.
| Arm | Type | Receives |
|---|---|---|
| Synchronous Telerehabilitation Group | Experimental | Behavioral: Synchronous Telerehabilitation Exercise ProgramParticipants will receive synchronous telerehabilitation via video calls (WhatsApp) 3 times per week for 8 weeks. Each session will last 40-50 minutes and include prescribed exercise programs under live supervision. |
| Asynchronous Telerehabilitation Group | Experimental | Behavioral: Asynchronous Telerehabilitation Exercise ProgramParticipants will receive asynchronous telerehabilitation with exercise videos delivered every 2 weeks via WhatsApp. Exercises will be performed 3 times per week for 8 weeks with feedback provided by message or phone call. An exercise diary will be used to monitor adherence. |
| Control Group | Active comparator | Behavioral: Brochure ProgramParticipants will receive a printed exercise brochure containing the same program as the intervention groups, updated every 2 weeks. They will be asked to perform the exercises 3 times per week for 8 weeks. An exercise diary will be used to monitor adherence. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-65
- Having been diagnosed with Ankylosing Spondylitis by a specialist at least one year ago,
- Agreeing to participate in the study voluntarily,
- Owning and being able to use a smartphone,
- Being able to read and write.
Key exclusion criteria (10 listed)
- Having a history of pregnancy, malignancy, or recent surgery (within the last six months)
- Having a history of hypertension and diabetes that cannot be controlled with medication
- Having a history of exacerbations in the last three weeks and having received treatment for exacerbations
- Having instable medical treatment within the last three months
- Having any orthopedic, neurological, or mental illness that would affect exercise
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 |
|---|---|---|
| Synchronous Telerehabilitation Exercise ProgramParticipants receive supervised synchronous telerehabilitation via video calls (WhatsApp) three times per week for 8 weeks. Each session lasts 40-50 minutes and includes mobility and exercise training under live supervision. | Behavioural | Synchronous Telerehabilitation Group |
| Asynchronous Telerehabilitation Exercise ProgramParticipants receive asynchronous telerehabilitation with exercise videos sent every 2 weeks via WhatsApp. Exercises are performed 3 times per week for 8 weeks. Feedback is provided by message or phone call, and participants keep an exercise diary for adherence tracking. | Behavioural | Asynchronous Telerehabilitation Group |
| Brochure ProgramParticipants receive a printed exercise brochure containing the same program as the intervention groups, updated every 2 weeks. They are asked to perform the exercises 3 times per week for 8 weeks and keep an exercise diary for adherence tracking. | Behavioural | Control Group |
Primary outcome
Change in cervical rotation (degrees) from baseline to 8 weeks
Time frame: 8 weeks
Cervical rotation is measured in degrees using a goniometer to assess mobility in individuals with Ankylosing Spondylitis. The mean value of left and right cervical rotation measurements for each participant will be recorded at baseline and at 8 weeks, and the change from baseline to 8 weeks will be reported.
Change from baseline in Tampa Scale of Kinesiophobia (TSK)
Time frame: 8 weeks
Change from baseline in Tampa Scale of Kinesiophobia (TSK) after 8 weeks. TSK is scored from 17 to 68, with higher scores indicating greater fear of movement/kinesiophobia.
Change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Time frame: 8 weeks
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scale after 8 weeks. ASQoL is scored from 0 to 18, with higher scores indicating worse quality of life.
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 8 weeks
BASFI is a validated questionnaire assessing functional ability in patients with ankylosing spondylitis. It consists of 10 items scored on a 0-10 scale. The mean of the 10 items will be used to calculate a total BASFI score (range 0-10), with higher scores indicating greater functional limitation.
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 8 weeks
BASDAI is a validated index used to determine disease activity in individuals with ankylosing spondylitis. It consists of six questions assessing fatigue, spinal pain, joint pain/swelling, enthesitis, and duration and severity of morning stiffness. Each question is scored on a 0-10 numerical rating scale, and the total BASDAI score is calculated as the mean of these values (range 0-10). Higher scores indicate greater disease activity.
Change in Visual Analog Scale (VAS) pain score at rest from baseline after 8 weeks
Time frame: 8 weeks
Pain intensity at rest will be evaluated using a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Change in Visual Analog Scale (VAS) pain score during movement from baseline after 8 weeks
Time frame: 8 weeks
Pain intensity during movement will be evaluated using a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Change in Visual Analog Scale (VAS) pain score during sleep from baseline after 8 weeks
Time frame: 8 weeks
Pain intensity during sleep will be evaluated using a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Change in tragus-to-wall distance (cm) from baseline to 8 weeks
Time frame: 8 weeks
Tragus-to-wall distance is measured in centimeters as part of spinal mobility assessment in individuals with Ankylosing Spondylitis. The mean of left and right tragus-to-wall measurements for each participant will be recorded at baseline and at 8 weeks, and the change from baseline to 8 weeks will be reported.
Change in lumbar side flexion (cm) from baseline to 8 weeks
Time frame: 8 weeks
Lumbar side flexion is measured in centimeters to assess lateral mobility of the lumbar spine. The mean of left and right measurements for each participant will be recorded at baseline and at 8 weeks, and the change from baseline to 8 weeks will be reported.
Change in lumbar flexion (Modified Schober's test, cm) from baseline to 8 weeks
Time frame: 8 weeks
Lumbar flexion is measured in centimeters using the Modified Schober's test to assess forward mobility of the lumbar spine. Each participant's measurements at baseline and at 8 weeks will be recorded, and the change from baseline to 8 weeks will be reported.
Change in intermalleolar distance (cm) from baseline to 8 weeks
Time frame: 8 weeks
Intermalleolar distance is measured in centimeters to assess hip mobility in individuals with Ankylosing Spondylitis. Each participant's measurements at baseline and at 8 weeks will be recorded, and the change from baseline to 8 weeks will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided. Plan Description: De-identified individual participant data (IPD) collected in this study, including BASFI, BASDAI, BASMI, ASQoL, TSK, and VAS scores, will not be shared outside the research team due to patient confidentiality and ethical restrictions. Access Criteria: Data will only be available to the investigators of this study. Requests from external researchers cannot be accommodated. Available IPD/Information: Not applicable.
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.
Fırat University Faculty of Medicine, Department of Internal Medicine - Division of Rheumatology.
Elâzığ, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous Telerehabilitation Exercise Program, Asynchronous Telerehabilitation Exercise Program and Brochure Program in people with Anklyosing Spondylitis and Telerehabilitation, run by Inonu University at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cervical rotation (degrees) from baseline to 8 weeks (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.