Clinical trial NCT04803383: The Effects of Tele-Yoga in Ankylosing Spondylitis Patients
Official title: The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Yoga
Keywords: ankylosing spondylitis
yoga
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)
timeFrame: Change from Baseline at 8 weeks
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Change from Baseline at 8 weeks
measure: Assessment of Spondyloarthritis international Society Health Index (ASAS HI)
timeFrame: Change from Baseline at 8 weeks
measure: Muscular endurance:
timeFrame: Change from Baseline at 8 weeks
measure: Balance
timeFrame: Change from Baseline at 8 weeks
measure: Aerobic Capacity
timeFrame: Change from Baseline at 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from Baseline at 8 weeks
measure: The Hospital Anxiety And Depression Scale(HADS)
timeFrame: Change from Baseline at 8 weeks
measure: Stress
timeFrame: Change from Baseline at 8 weeks
measure: Mindfulness
timeFrame: Change from Baseline at 8 weeks
measure: Short Form-36 (SF-36)
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University
Study officials:
affiliation: Dokuz Eylul University
name: YASEMİN ACAR
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: NURSEN İLÇİN
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: İSMAİL SARI
role: STUDY_CHAIR
References: