The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

NCT04803383 | Completed DMC

• 1 other identifier: 2021/05-34
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Ankylosing Spondylitis; Yoga

Keywords

ankylosing spondylitis; yoga

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• Assessment of Spondyloarthritis international Society Health Index (ASAS HI)

  Change from Baseline at 8 weeks

• Muscular endurance:

  Change from Baseline at 8 weeks

• Balance

  Change from Baseline at 8 weeks

Study Arms (2)

Tele-Yoga Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Tele-yoga OTHER

Tele-yoga training 3 days a week for 8 weeks

Tele-Yoga Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, 35320, Turkey (Türkiye)

Location

Related Publications (1)

• Acar Y, Ilcin N, Sari I. The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial. J Integr Complement Med. 2023 Nov;29(11):727-737. doi: 10.1089/jicm.2023.0022. Epub 2023 May 31.

  PMID: 37257184 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• YASEMİN ACAR

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• NURSEN İLÇİN

  Dokuz Eylul University

  STUDY DIRECTOR

• İSMAİL SARI

  Dokuz Eylul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: April 14, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)