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

Sponsor
Acibadem University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06000072
Collaborator
Haydarpasa Numune Training and Research Hospital (Other)
60
2
2
7.6
30
3.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Core Exercise Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis
Actual Study Start Date :
Aug 11, 2023
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Core Endurance Tests : Trunk Flexion Test [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.

  2. Core Endurance Tests : Side Plank (Side Bridge Test): [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.

  3. Core Endurance Tests : Modified Plank [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.

  4. Core Endurance Tests : Biering-Sorenson Test [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.

  5. Core Endurance Tests : 30 Second Sit and Stand Test [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.

Secondary Outcome Measures

  1. Bath Ankylosing Spondylitis Functional Index (BASFI) [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).

  2. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [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).

  3. Bath Ankylosing Spondylitis Metrology Index (BASMI) [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.

  4. Global Rating of Change (GROC) [8 weeks]

    It is used to assess the patient's current health status and to calculate the difference between the initial health status.

  5. Pain intensity (Numeric Rating Scale/NRS) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haydarpasa Numune Research and Training Hospital Istanbul Turkey 34752
2 Acıbadem Mehmet Ali Aydınlar University Istanbul Turkey

Sponsors and Collaborators

  • Acibadem University
  • Haydarpasa Numune Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Özgül Öztürk, Assistant Professor, Acibadem University
ClinicalTrials.gov Identifier:
NCT06000072
Other Study ID Numbers:
  • ATADEK 2023 - 10/341
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023