The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Bath Ankylosing Spondylitis Functional Index (BASFI)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tele-Yoga Group
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
Intervention: Tele-yoga (Other)
Control group
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.
Outcomes
Primary Outcomes
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Change from Baseline at 8 weeks
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.
Secondary Outcomes
- Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)(Change from Baseline at 8 weeks)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Change from Baseline at 8 weeks)
- Balance(Change from Baseline at 8 weeks)
- Muscular endurance:(Change from Baseline at 8 weeks)
- Short Form-36 (SF-36)(Change from Baseline at 8 weeks)
- Pittsburgh Sleep Quality Index(Change from Baseline at 8 weeks)
- Aerobic Capacity(Change from Baseline at 8 weeks)
- The Hospital Anxiety And Depression Scale(HADS)(Change from Baseline at 8 weeks)
- Assessment of Spondyloarthritis international Society Health Index (ASAS HI)(Change from Baseline at 8 weeks)
- Stress(Change from Baseline at 8 weeks)
- Mindfulness(Change from Baseline at 8 weeks)
Investigators
Yasemin ACAR
Research assistant
Dokuz Eylul University