Effectiveness of Telerehabilitation in Ankylosing Spondylitis

NCT07503327 | Recruiting

• 1 other identifier: AS- Telerehabilitation
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anklyosing Spondylitis; Telerehabilitation

Keywords

Spondylitis, Ankylosing; Telemedicine; Rehabilitation; Mobility Limitation

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  8 weeks

Study Arms (3)

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.

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.

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.

Behavioral: Brochure Program

Interventions

Synchronous Telerehabilitation Exercise Program BEHAVIORAL

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.

Synchronous Telerehabilitation Group

Asynchronous Telerehabilitation Exercise Program BEHAVIORAL

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.

Asynchronous Telerehabilitation Group

Brochure Program BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Failure to attend three consecutive treatment sessions,
• Failure to complete the tests and questionnaires,
• Voluntarily withdrawing from the study.

Sponsors & Collaborators

• Inonu University: lead
• Firat University: collaborator

Study Sites (1)

Fırat University Faculty of Medicine, Department of Internal Medicine - Division of Rheumatology.

Elâzığ, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing; Mobility Limitation

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be performed as the nature of the interventions does not allow blinding of participants or investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research asistant

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: March 31, 2026
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

TU (1)