The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of tele-yoga on functional level, disease activity, spinal mobility, balance, aerobic capacity, sleep quality, anxiety, depression, stress, mindfulness and quality of life in patients with ankylosing spondylitis

Detailed Description
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Yoga is an ancient discipline that emerged in India thousands of years ago, designed to bring balance and health to the physical, mental, emotional and spiritual dimensions of the individual.Due to its therapeutic effects, yoga can be considered as an alternative approach for those with rheumatic disease. Because of Covid-19, which has changed the world and the lifestyle of people, tele-yoga practice can be considered as an alternative instead of traditional face-to-face yoga classes. The use of online platforms provides a good environment for yoga training at home. The aim of this study is to investigate the effects of tele-yoga on functional level, disease activity, spinal mobility, balance, sleep quality, depression, mindfulness and quality of life in patients with ankylosing spondylitis. 60 AS patients who meet the inclusion criteria will be assigned to the tele-yoga or waiting list control group by the block randomization method. Patients in the tele-yoga group will participate in tele-yoga sessions with a maximum of 5 people in each group by video-conference method for 8 weeks, 3 days a week. Assessments will perform just before starting to study and after the 8-week tele-yoga program. Patients in the waiting list control group will be asked to continue their normal physical activities during the 8-week study, not to start a new exercise program, and to report any changes in the drug or dosage used. Control group's assessments will be performed when they are included in the study and at the end of 8 weeks. After these assessments, patients who wish will participate in the tele-yoga program.

Official Title
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The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial

Conditions
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Yoga, Ankylosing Spondylitis

Intervention / Treatment
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* Other: Tele-yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ankylosing spondylitis(AS) patients diagnosed according to modified New York criteria To be volunteer To have the necessary equipment to provide internet access and connection Exclusion Criteria: Presence of systemic, orthopedic neurological or cognitive disease other than ankylosing spondylitis Regular exercise in the last 3 months Pregnancy Not attending 4 consecutive yoga sessions Changing the drug during the study Has an acute attack during the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-Yoga Group<br>Patients in the tele-yoga group will participate in tele-yoga sessions with a maximum of 5 people in each group by video-conference method for 8 weeks, 3 days a week. Assessments will perform just before starting to study and after the 8-week tele-yoga program | Other: Tele-yoga<br>* Tele-yoga training 3 days a week for 8 weeks<br>|
| No Intervention: Control group<br>Patients in the waiting list control group will be asked to continue their normal physical activities during the 8-week study, not to start a new exercise program, and to report any changes in the drug or dosage used. Control group's assessments will be performed when they are included in the study and at the end of 8 weeks. After these assessments, patients who wish will participate in the tele-yoga program. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | Assess functional capacity. This self-assessment instrument consists of eight specific questions regarding function in AS and two questions reflecting the patient's ability to cope with everyday life regarding function in AS and two questions reflecting the patient's ability to cope with everyday life.The BASFI score is calculated by dividing the sum of the scores from 10 questions by 10. Score range is 0-10, with 0 reflecting no functional impairments and 10 reflecting maximal impairment. | Change from Baseline at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI) | Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility. | Change from Baseline at 8 weeks | 
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Assess disease activity. The total score ranges from 0 to 10. High scores mean an increase in disease activity. | Change from Baseline at 8 weeks | 
| Assessment of Spondyloarthritis international Society Health Index (ASAS HI) | The ASAS HI contains 17 items (dichotomous response option: 'I agree' and 'I do not agree') addressing different aspects of functioning. The total ASAS HI score is between 0 and 17. Lower score indicates a better and a higher score indicates an inferior health status | Change from Baseline at 8 weeks | 
| Muscular endurance: | Sit-up and push-up tests will be used to evaluate muscular endurance. | Change from Baseline at 8 weeks | 
| Balance | Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA). | Change from Baseline at 8 weeks | 
| Aerobic Capacity | The incremental Shuttle Walk Test will be used to determine aerobic capacity | Change from Baseline at 8 weeks | 
| Pittsburgh Sleep Quality Index | Assess quality of sleep | Change from Baseline at 8 weeks | 
| The Hospital Anxiety And Depression Scale(HADS) | The HADS is a 14-item self-report questionnaire that measures anxiety (7 items) and depression (7 items) symptoms. | Change from Baseline at 8 weeks | 
| Stress | Stress will be assessed with Perceived Stress Scale (PSS).The scale consists of 14 items and total score ranges from 0 to 56. High scores indicate high stress perception. | Change from Baseline at 8 weeks | 
| Mindfulness | Mindful Attention Awareness Scale will be used. The scale consists of 15 items. The total score that can be obtained from the scale is between 15 and 90. High scores reflect more mindfulness. | Change from Baseline at 8 weeks | 
| Short Form-36 (SF-36) | Assess quality of life | Change from Baseline at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankylosing spondylitis, yoga