The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

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

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

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis; Yoga
• Intervention / Treatment: Other: Tele-yoga

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35320
    • Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Tele-yoga; Tele-yoga training 3 days a week for 8 weeks
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: YASEMİN ACAR, Dokuz Eylül University; Study Chair: İSMAİL SARI, Dokuz Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: yoga; ankylosing spondylitis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: 2021/05-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No