Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis

February 20, 2024 updated by: Özgül Öztürk, Acibadem University

Exercise is a core treatment method in the management of Axial Spondyloarthritis. Clinical guidelines recommend a combination of pharmacologic and non-pharmacologic approaches to reduce disease activity and symptoms and improve physical function. The COVID-19 pandemic has accelerated the provision of healthcare services remotely and the digitalization of rehabilitation services. Telerehabilitation methods provide advantages in terms of transportation, prevention of infections that may occur due to suppression of immunity with drugs, and continuity of treatment in patients with axial spondyloarthritis. In this context, it is important to evaluate the effects of remote physiotherapy and rehabilitation delivery in chronic inflammatory rheumatic diseases. This study, which will examine the effects of telerehabilitation in the disease management processes of individuals with axial spondyloarthritis, is thought to shed light on future studies.

The aim of this study was to compare the effectiveness of telerehabilitation or pre-recorded video-based core exercise program on core endurance, disease activity and physical function in subjects with axial spondyloarthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Acıbadem Mehmet Ali Aydınlar University
        • Contact:
        • Sub-Investigator:
          • Ece Nur Şen
      • Istanbul, Turkey, 34752
        • Recruiting
        • Haydarpasa Numune Research and Training Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 - 55 years old,
  • Axial Spondyloarthritis diagnosed by a rheumatologist,
  • Not having any orthopedic, neurological, or mental illness that would affect exercise,
  • Not using any assistive device for ambulation
  • People who volunteer to participate

Exclusion Criteria:

  • Pregnancy, malignancy, and recent surgery
  • Presence of cardiopulmonary disease
  • Patients with endoprosthesis and prosthesis
  • Attending a regular exercise program (Pilates, core, or yoga etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation
Telerehabilitation sessions including core exercises
Other: Core Exercise Program
Core exercises
Active Comparator: Video-based
Core exercises by watching pre-recorded videos
Other: Core Exercise Program
Core exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Endurance Tests : Trunk Flexion Test
Time Frame: 8 weeks
The patient will be asked to cross his/her hands over his/her chest and positioned with the trunk in 60° flexion and knees in 90° flexion. The time in this position will be measured and recorded with a stopwatch. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
8 weeks
Core Endurance Tests : Side Plank (Side Bridge Test):
Time Frame: 8 weeks
The patient will be asked to lie on his/her side on the dominant side and cross his/her foot over the other foot. The non-dominant arm will be crossed over the chest and placed over the dominant shoulder. The patient will be asked to stand on the dominant forearm and elbow. The time in this position will be measured with a cronometer and recorded. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
8 weeks
Core Endurance Tests : Modified Plank
Time Frame: 8 weeks
The patient will be asked to position on his/her knees and elbows with his/her face to the floor. He/she will be fixed over his/her knees with the help of a belt and the duration of his/her stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
8 weeks
Core Endurance Tests : Biering-Sorenson Test
Time Frame: 8 weeks
Patients will be positioned in a prone position with their spina iliaca anterior superior to the edge of the bed. Participants will be asked to extend their upper body straight forward from the edge of the table. They will be immobilized over their knees with the help of a belt and the time they stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.
8 weeks
Core Endurance Tests : 30 Second Sit and Stand Test
Time Frame: 8 weeks
The patient sits and stands for 30 s in a chair whose height is adjusted so that the knees are 90° when seated. The number of times the patient can sit and stand during this time will be calculated and recorded.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: 8 weeks
The questionnaire used to assess physical function in patients consists of 10 items related to activities of daily living. Each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible).
8 weeks
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: 8 weeks
The BASDAI is used to measure ankylosing spondylitis disease activity. In this index, fatigue, pain due to spinal and peripheral joint involvement, local tenderness at the sites of insertion, duration and severity of morning stiffness in the last 1 week are evaluated. It consists of a total of 6 items and each item is scored between 0-10 (0 meaning no difficulty, 10 meaning impossible).
8 weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: 8 weeks
It is an index that includes several measurements used to evaluate spinal mobility. These measurements are tragus-wall distance, lumbar lateral flexion test, Modified Schober test, intermalleolar distance.
8 weeks
Global Rating of Change (GROC)
Time Frame: 8 weeks
It is used to assess the patient's current health status and to calculate the difference between the initial health status.
8 weeks
Pain intensity (Numeric Rating Scale/NRS)
Time Frame: 8 weeks
It is a scale used to determine the severity of pain. It allows the patient to describe their pain in numbers. The scale starts with the absence of pain (0) and is expressed as unbearable pain (10 or 100).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Collaborators

Haydarpasa Numune Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK 2023 - 10/341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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