- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392620
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
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
- Name: Songul Baglan Yentur
- Phone Number: +90 424 2370000
- Email: songulbaglan23@hotmail.com
Study Locations
-
-
Elazig
-
Elazığ, Elazig, Turkey, 23100
- Recruiting
- Songul Baglan Yentur
-
Contact:
- Songul Baglan Yentur
- Phone Number: 04242370000
- Email: songulbaglan23@hotmail.com
-
-
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/03-08
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.
Clinical Trials on Ankylosing Spondylitis
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
-
AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
-
Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
-
AbbVieCompletedAnkylosing Spondylitis (AS)United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, United Kingdom
-
Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
-
Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
-
AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
-
Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
-
Jiangsu vcare pharmaceutical technology co., LTDRecruitingActive Ankylosing SpondylitisChina
-
Assiut UniversityUnknownActive Sacroiliitis in Ankylosing Spondylitis
Clinical Trials on Study Group
-
Romanian Society of Anesthesia and Intensive CareUniversity of Medicine and Pharmacy "Victor Babes" Timisoara; Timişoara County...Completed
-
Mehmet GÖĞREMİŞKahramanmaras Sutcu Imam UniversityCompletedFemale Patients Diagnosed With LDH at L4-S1Turkey
-
Alanya Alaaddin Keykubat UniversityCompletedTemporomandibular Joint Disorders | Physiotherapy | Vertigo, Paroxysmal | Soft Tissue Mobilisation | Vestibular ExercisesTurkey
-
Muş Alparlan UniversityNot yet recruitingSTROKE REHABİLİTATİONTurkey
-
Medical University of GrazRoyal Alexandra HospitalCompletedBrain Injuries | Preterm Infant | Birth HypoxiaAustria, Canada, Ireland, Slovenia, Germany, Poland, Italy
-
Istanbul Sureyyapasa Chest Diseases and Chest Surgery...CompletedSleep Disorder | Obstructive Sleep Apnea of Adult | Patient ComplianceTurkey
-
Cairo UniversityCompletedCarpal Tunnel Syndrome
-
Loma Linda UniversityTerminatedType 1 Diabetes Mellitus
-
Medtronic BRCMedtronicCompletedAtrial Fibrillation | Sinus ArrhythmiaItaly
-
Firat UniversityRecruiting