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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06392620
Other study ID # 2024/03-08
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2024
Est. completion date July 20, 2024

Study information

Verified date April 2024
Source Firat University
Contact Songul Baglan Yentur
Phone +90 424 2370000
Email songulbaglan23@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 20, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Study Group
n individually planned exercise program including stretching, strengthening, respiratory, aerobic and posture exercises will be applied via video conference method

Locations

Country Name City State
Turkey Songul Baglan Yentur Elazig Elazig

Sponsors (1)

Lead Sponsor Collaborator
Firat University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spinal mobility 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 Disease activity Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) consisting of 6 questions will be used to assess disease activity. 1 minute
Secondary Function 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
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