NCT07503327

Effectiveness of Telerehabilitation in Ankylosing Spondylitis

Investigation of the Effectiveness of Different Telerehabilitation Applications in Patients With Ankylosing Spondylitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Inonu University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Anklyosing Spondylitis
• Telerehabilitation

Interventions

Type	Name	Description
BEHAVIORAL	Synchronous Telerehabilitation Exercise Program	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.
BEHAVIORAL	Asynchronous Telerehabilitation Exercise Program	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.
BEHAVIORAL	Brochure Program	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-04-01
• Completion: 2026-12-31
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: Turkey (Türkiye)