The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803383
• Other study ID #: 2021/05-34
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: April 2022
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• 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

• 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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing
• Yoga

Intervention

Other:
• Tele-yoga
Tele-yoga training 3 days a week for 8 weeks

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University	Izmir

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 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	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
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.	Change from Baseline at 8 weeks
Secondary	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
Secondary	Muscular endurance:	Sit-up and push-up tests will be used to evaluate muscular endurance.	Change from Baseline at 8 weeks
Secondary	Balance	Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).	Change from Baseline at 8 weeks
Secondary	Aerobic Capacity	The incremental Shuttle Walk Test will be used to determine aerobic capacity	Change from Baseline at 8 weeks
Secondary	Pittsburgh Sleep Quality Index	Assess quality of sleep	Change from Baseline at 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Short Form-36 (SF-36)	Assess quality of life	Change from Baseline at 8 weeks