Skip to main content
Clinical Trials/NCT05006690
NCT05006690
Completed
Not Applicable

Comparison of the Effects of Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise Training in Individuals With Axial Spondyloarthritis

Hacettepe University1 site in 1 country50 target enrollmentStarted: December 18, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Evaluation of Functional Level

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Evaluation of Functional Level

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

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.

Evaluation of Disease Activity

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

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.

Secondary Outcomes

  • 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 Biopsychosocial Status(10 minutes, through study completion, an average of 8 weeks, change from baseline biopsychosocial status at 8 weeks.)
  • Evaluation of Physical Performance(10-15 minutes, through study completion, an average of 8 weeks, change from baseline physical performance at 8 weeks.)
  • Evaluation of Illness Perception(3 minutes, through study completion, an average of 8 weeks, change from baseline illness perception at 8 weeks.)
  • Evaluation of Kinesiophobia(5 minutes, through study completion, an average of 8 weeks, change from baseline kinesiophobia at 8 weeks)
  • Side Bridge Endurance Test: Evaluation of spinal stabilization(Testing time depends on the patient, through study completion, an average of 8 weeks, change from baseline spinal stabilization 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 Depression and Anxiety Levels(7 minutes, through study completion, an average of 8 weeks, change from baseline depression and anxiety levels at 8 weeks.)
  • ASAS (Assessment of SpondyloArthritis International Society) Health Index (ASAS-HI): Evaluation of health and disability(5 minutes, through study completion, an average of 8 weeks, change from baseline disability at 8 weeks.)
  • Evaluation of rib cage mobility: Chest Expansion Measurement(2 minutes, through study completion, an average of 8 weeks, change from baseline chest expansion at 8 weeks.)
  • Exercise Self-Efficacy Scale (ESES): Assessment of exercise self-efficacy(5 minutes, through study completion, an average of 8 weeks, change from baseline self-efficacy at 8 weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nur Banu Karaca

Research Assistant, Physiotherapist

Hacettepe University

Study Sites (1)

Loading locations...

Similar Trials