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NCT04281238 Clinical Trial

The Effects of Yoga Training in Ankylosing Spondylitis Patients

Ankylosing Spondylitis Clinical Trial

Official title:
The Effects of Yoga Training in Ankylosing Spondylitis Patients

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04281238
Other study ID # 2019/07-20
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date October 26, 2020
Est. completion date December 2021

Study information
Verified date January 2021
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate the effect of yoga training on functional level, disease activity, spinal mobility, balance, sleep quality, depression and quality of life in AS patients.

Description:

Yoga is an ancient Indian practice, dating back several thousand years, with objective of uniting mind, body, and spirit. In Western cultures, Hatha yoga is most commonly practiced, and generally includes a set of physical poses(asanas), breathing techniques(pranayama) and deep relaxation(savasana).Yoga has been shown to increase mobility, reduce pain, and improve quality of life in many diseases. However, there is no study examining the effects of yoga training in AS patients.Therefore, the aim of this study is to investigate the effects of yoga training in AS patients. 60 AS patients aged 20-60 years will be randomly assigned to yoga or control group. Home exercises will be taught to both groups, and a brochure with home exercises will be given. The yoga group will participate in a yoga class 3 days a week, during 8 weeks. The control group will not participate in a yoga class, only will do home exercises. Assessments will be done at baseline and after 8 weeks.

Recruitment information / eligibility
Status Suspended
Enrollment 60
Est. completion date December 2021
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Ankylosing spondylitis(AS) patients diagnosed according to modified New York criteria - To be volunteer Exclusion Criteria: - the presence of peripheral enthesitis, orthopedic disorders, cardiovascular disorders, neurological disorders, visual and auditory deficits, - history of surgery for spine or lower limb, - failure to complete the test

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Yoga group
Yoga training 3 days a week for 8 weeks. In addition to this, home exercises 5 days a week for 8 weeks
• Control group
Home exercises 5 days a week for 8 weeks

Locations
Country Name City State
Turkey Dokuz Eylül University Izmir Eyalet/Yerleske

Sponsors (1)
Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI) Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility. 5 minutes
Secondary 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. 2 minutes
Secondary 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. 3 minutes
Secondary Short Form-36 (SF-36) Assess quality of life 6 minutes
Secondary Beck Depression Inventory Assess depression 5 minutes
Secondary Beck Anxiety Inventory Assess anxiety 4 minutes
Secondary Pittsburgh Sleep Quality Index Assess quality of sleep 4 minutes
Secondary Balance Master system Assess balance 10 minutes
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