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Completed

NCT Number: NCT04803383

The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

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

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Yoga

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül University

Izmir, 35320, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-Yoga

Other

Tele-yoga training 3 days a week for 8 weeks

Primary outcomes

  1. 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

  1. Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)

    Time frame: Change from Baseline at 8 weeks

    Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility.

  2. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Change from Baseline at 8 weeks

    Assess disease activity. The total score ranges from 0 to 10. High scores mean an increase in disease activity.

  3. Assessment of Spondyloarthritis international Society Health Index (ASAS HI)

    Time frame: Change from Baseline at 8 weeks

    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

  4. Muscular endurance:

    Time frame: Change from Baseline at 8 weeks

    Sit-up and push-up tests will be used to evaluate muscular endurance.

  5. Balance

    Time frame: Change from Baseline at 8 weeks

    Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).

  6. Aerobic Capacity

    Time frame: Change from Baseline at 8 weeks

    The incremental Shuttle Walk Test will be used to determine aerobic capacity

  7. Pittsburgh Sleep Quality Index

    Time frame: Change from Baseline at 8 weeks

    Assess quality of sleep

  8. The Hospital Anxiety And Depression Scale(HADS)

    Time frame: Change from Baseline at 8 weeks

    The HADS is a 14-item self-report questionnaire that measures anxiety (7 items) and depression (7 items) symptoms.

  9. Stress

    Time frame: Change from Baseline at 8 weeks

    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.

  10. Mindfulness

    Time frame: Change from Baseline at 8 weeks

    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.

  11. Short Form-36 (SF-36)

    Time frame: Change from Baseline at 8 weeks

    Assess quality of life

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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