Clinical trial NCT05006690: Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise in Individuals With Axial Spondyloarthritis
Official title: Comparison of the Effects of Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise Training in Individuals With Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Axial Spondyloarthritis
Ankylosing Spondylitis
Keywords: spinal stabilization exercise
telerehabilitation
clinical pilates
Ankylosing spondylitis
Axial spondyloarthritis
biopsychosocial
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluation of Functional Level
timeFrame: 5 minutes, through study completion, an average of 8 weeks, change from baseline functional level at 8 weeks.
measure: Evaluation of Disease Activity
timeFrame: 3 minutes, through study completion, an average of 8 weeks, change from baseline disease activity at 8 weeks.
Secondary outcomes:
measure: Evaluation of Spinal Mobility and Hip Function
timeFrame: 10 minutes, through study completion, an average of 8 weeks, change from baseline spinal mobility and hip function at 8 weeks.
measure: Evaluation of Quality of Life
timeFrame: 1 minutes, through study completion, an average of 8 weeks, change from baseline quality of life at 8 weeks.
measure: Evaluation of Biopsychosocial Status
timeFrame: 10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.
measure: Evaluation of Depression and Anxiety Levels
timeFrame: 7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.
measure: Evaluation of Kinesiophobia
timeFrame: 5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks
measure: Evaluation of Illness Perception
timeFrame: 3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.
measure: Evaluation of Physical Performance
timeFrame: 10-15 minutes, through study completion, an average of 8 weeks, change from baseline physical performance at 8 weeks.
measure: Evaluation of rib cage mobility: Chest Expansion Measurement
timeFrame: 2 minutes, through study completion, an average of 8 weeks, change from baseline chest expansion at 8 weeks.
measure: Side Bridge Endurance Test: Evaluation of spinal stabilization
timeFrame: Testing time depends on the patient, through study completion, an average of 8 weeks, change from baseline spinal stabilization at 8 weeks.
measure: Exercise Self-Efficacy Scale (ESES): Assessment of exercise self-efficacy
timeFrame: 5 minutes, through study completion, an average of 8 weeks, change from baseline self-efficacy at 8 weeks.
measure: ASAS (Assessment of SpondyloArthritis International Society) Health Index (ASAS-HI): Evaluation of health and disability
timeFrame: 5 minutes, through study completion, an average of 8 weeks, change from baseline disability at 8 weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Study officials:
References: