Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise in Individuals With Axial Spondyloarthritis

NCT05006690 | Completed DMC

• 1 other identifier: KA-21035
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Spondyloarthritis (SpA) refers to a group of rheumatic diseases that share common clinical, genetic and imaging features. They are divided into two: axial (axSpA) and peripheral. In addition to the pain caused by sacroiliitis and spondylitis, which are the main complaints, patients often experience joint stiffness, fatigue, mood disturbances and various degrees of functional limitations, and the quality of life of individuals can be significantly affected. Although there is consensus about the positive effects of exercise in AxSpA, no exercise regimen has been shown to be superior to another. Another exercise model whose effectiveness has been researched in recent years is "clinical pilates exercises". It is a version of the Pilates exercises created by Joseph Pilates, modified by physiotherapists to emphasize the most valuable components in the diagnosis and management of injuries and to increase their safety. Clinical Pilates exercises are an exercise model based on spinal stabilization principles. In addition, it has the principles of awareness, balance, breathing, concentration, centering, control, efficiency, flow, sensitivity, isolation and harmony. There are many studies investigating the effects of these exercises in the field of rehabilitation and highlighting improvements in different diseases, including ankylosing spondylitis, which is considered the prototype of axSpA. No study has been found examining exercise training applied via telerehabilitation to individuals with AxSpA and its effects. The aim of this study is to compare the effects of telerehabilitation and face-to-face clinical pilates-based exercise training on individuals with axial spondyloarthritis. Volunteers who meet the inclusion criteria will be randomly divided into 'telerehabilitation training group' and 'face-to-face training group' using the sealed envelope method. The individualized rehabilitation program will be applied to each group for 1 hour, 3 days a week, for 8 weeks. Disease-specific performance measurements and patient-reported scales that evaluate patients' disease activity, functionality, mood, quality of life, fear-avoidance, levels and perceptions of the disease will be applied to individuals three times in total: at the beginning, after the 8-week rehabilitation program and 6 months after the second evaluation.

Conditions

Axial Spondyloarthritis; Ankylosing Spondylitis

Keywords

spinal stabilization exercise; telerehabilitation; clinical pilates; Ankylosing spondylitis; Axial spondyloarthritis; biopsychosocial

Outcome Measures

Primary Outcomes (2)

• Evaluation of Functional Level

  Bath Ankylosing Spondylitis Functional Index (BASFI): The index consists of 10 questions in total. For each item, the patient marks the VAS consisting of a 100 mm line. The score range is 0-100. The Turkish version study was conducted by Karatepe et al. made by. A high score indicates a bad result.

  5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.

• Evaluation of Disease Activity

  Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): The index consists of 6 items questioning 5 symptoms in total. The response of each item is evaluated with the Visual Analog Scale (VAS). A total score of ≥ 4 indicates active disease. Turkish version study Akkoç et al. made by.

  3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.

Secondary Outcomes (11)

• Evaluation of Spinal Mobility and Hip Function

  10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.

• Evaluation of Quality of Life

  1 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.

• Evaluation of Biopsychosocial Status

  10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.

• Evaluation of Depression and Anxiety Levels

  7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.

• Evaluation of Kinesiophobia

  5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks

Study Arms (2)

Telerehabilitation Training Group

EXPERIMENTAL

In the telerehabilitation group, an individualized rehabilitation program according to the principles of clinical pilates exercises based on spinal stabilization will be applied via video conference, 3 days a week, 1 hour, online in real-time, accompanied by a physiotherapist, for 8 weeks. In the first session, informative training about the disease (pathophysiology of axial spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.

Other: Clinical Pilates-Based Exercise Training

Face-to-Face Training Group

EXPERIMENTAL

In the face-to-face training group, an individualized rehabilitation program according to the principles of clinical pilates exercises based on spinal stabilization will be applied in the clinic under the supervision of a physiotherapist for 1 hour, 3 days a week, for 8 weeks. In the first session, informative training about the disease (pathophysiology of axial spondyloarthritis, its course, physical structures it covers, etc.), pain management training (information about the relationship between pain, muscle spasm, stress, depression, methods that can be used for coping with pain, etc.), exercise. The importance of exercise training (trunk stabilization, anatomy) and aims will be given within the scope of patient education.

Other: Clinical Pilates-Based Exercise Training

Interventions

Clinical Pilates-Based Exercise Training OTHER

Clinical Pilates-Based exercise training based on spinal stabilization aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine.

Face-to-Face Training Group; Telerehabilitation Training Group

Eligibility Criteria

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

You may qualify if:

• Diagnosed with axial spondyloarthritis
• Between the ages of 18-65,
• Literate,
• Having sufficient smartphone/computer knowledge to participate in the study or having a relative who can help in this regard,
• Having a smart phone/computer and an active internet connection,
• Individuals who have not exercised regularly in at least the last 3 months will be included in the study.

You may not qualify if:

• Having a diagnosis of uncontrolled/clinically significant other disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
• Malignancies
• Having a history of previous surgery on the spine and extremities and therefore loss of function,
• Pregnant individuals,
• Continuing another rehabilitation program,
• Have other conditions that prevent exercise,
• A significant change in medication regimen occurs while the study is ongoing,
• Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Physiotherapist

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 16, 2021
• Study Start: December 18, 2023
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)