Telerehabilitation in Ankylosing Spondylitis

April 26, 2024 updated by: Songül Bağlan Yentür, Firat University

Effects of Telerehabilitation in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis (AS) is an inflammatory rheumatic disease primarily affecting the spine and sacroiliac joint. xercise is one of the most important nonpharmacologic treatment modalities in AS. Stretching, strengthening, aerobic, posture, balance and moltimodal exercise methods are the most commonly used treatment methods. The study will include 44 patients diagnosed with AS aged 18-65 years. Patients will be divided into two randomized controlled groups with 22 patients in each group. Group 1 will receive a personalized exercise program including stretching, strengthening, respiratory, aerobic and posture exercises via video conferencing. Group 2 will be recommended a video on the YouTube platform and will be asked to perform the exercises by following the content of these videos. Spinal mobility will be assessed with Bath Ankylosing Spondylitis Metrology Index, disease activity with Bath Ankylosing Spondylitis Disease Activity Index, function with Bath Ankylosing Spondylitis Function Index, quality of life with Ankylosing Spondylitis Quality of Life Scale and posture with PostureScreeen mobile application.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Ankylosing Spondylitis (AS) is an inflammatory rheumatic disease primarily affecting the spine and sacroiliac joint. It usually begins in the second decade of life and is more common in men than women. The benefits of exercise and physical activity in health and disease are well recognized. Exercise is one of the most important nonpharmacologic treatment modalities in AS. Stretching, strengthening, aerobic, posture, balance and moltimodal exercise methods are the most commonly used treatment modalities. However, the application of these exercise methods to patients with AS in the form of a home exercise program is advantageous due to its low cost and the ease with which patients can start exercising. The study will include 44 patients diagnosed with AS aged 18-65 years. Patients will be divided into two randomized controlled groups with 22 patients in each group. Group 1 will receive a personalized exercise program including stretching, strengthening, respiratory, aerobic and posture exercises via video conferencing. Group 2 will be recommended a video on the YouTube platform and will be asked to perform the exercises by following the content of these videos. Patients in Group 2 will be followed up by regular communication with the patients and by asking the patient to create an attendance chart. Patients in both groups will receive the treatment 3 days a week for 8 weeks. Evaluation methods will be applied at the beginning and at the end of the treatment. Spinal mobility will be assessed with Bath Ankylosing Spondylitis Metrology Index, disease activity with Bath Ankylosing Spondylitis Disease Activity Index, function with Bath Ankylosing Spondylitis Function Index, quality of life with Ankylosing Spondylitis Quality of Life Scale and posture with PostureScreeen mobile application.

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Locations

    • Elazig
      • Elazığ, Elazig, Turkey, 23100

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 years old
  • Patients whose medical treatment has not changed in the last three months
  • Patients with a diagnosis of AS will be included.

Exclusion Criteria:

  • Patients who are pregnant
  • Patients with a diagnosis of malignancy
  • Patients with other concomitant systemic inflammatory rheumatic diseases
  • Patients with neurological, orthopedic or congenital problems that prevent physical activity
  • Patients with regular exercise habits will be excluded from the study

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: Study group
An individually planned exercise program including stretching, strengthening, respiratory, aerobic and posture exercises will be applied via video conference method.
n individually planned exercise program including stretching, strengthening, respiratory, aerobic and posture exercises will be applied via video conference method
Experimental: Control group
It will be recommended a video on YouTube platform and will be asked to do the exercises by following the content of these videos
n individually planned exercise program including stretching, strengthening, respiratory, aerobic and posture exercises will be applied via video conference method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal mobility
Time Frame: 10 minutes
Spinal mobility will be assessed and scored with BASMI. According to the index, there are five measurements: lateral lumbar flexion, tragus-wall distance, lumbar flexion (Modified Schober), maximal intermalleolar distance and cervical rotation.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 1 minute
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consisting of 6 questions will be used to assess disease activity.
1 minute
Function
Time Frame: 2 minutes
BASFI will be used to assess function. The index includes 10 questions about activities of daily living. A 10 cm VAS will be used for each question
2 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Songul Baglan Yentur, Firat University

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 (Estimated)

April 20, 2024

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

July 20, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

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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