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The Effects of Yoga Training in Ankylosing Spondylitis Patients

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ClinicalTrials.gov Identifier: NCT04281238
Recruitment Status : Suspended (Because of Covid-19)
First Posted : February 24, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Yasemin ACAR, Dokuz Eylul University

Tracking Information
First Submitted Date  ICMJE February 20, 2020
First Posted Date  ICMJE February 24, 2020
Last Update Posted Date January 12, 2021
Actual Study Start Date  ICMJE October 26, 2020
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2020)
Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI) [ Time Frame: 5 minutes ]
Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI) [ Time Frame: 5 minutes ]
Asses spinal mobility
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2020)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 2 minutes ]
    Assess disease activity. The total score ranges from 0 to 10. High scores mean an increase in disease activity.
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: 3 minutes ]
    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.
  • Short Form-36 (SF-36) [ Time Frame: 6 minutes ]
    Assess quality of life
  • Beck Depression Inventory [ Time Frame: 5 minutes ]
    Assess depression
  • Beck Anxiety Inventory [ Time Frame: 4 minutes ]
    Assess anxiety
  • Pittsburgh Sleep Quality Index [ Time Frame: 4 minutes ]
    Assess quality of sleep
  • Balance Master system [ Time Frame: 10 minutes ]
    Assess balance
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: 2 minutes ]
    Assess disease activity
  • Bath Ankylosing Spondylitis Funtional Index (BASFI) [ Time Frame: 3 minutes ]
    Assess functional capasity
  • Short Form-36 (SF-36) [ Time Frame: 6 minutes ]
    Assess quality of life
  • Beck Depression Inventory [ Time Frame: 5 minutes ]
    Assess depression
  • Beck Anxiety Inventory [ Time Frame: 4 minutes ]
    Assess anxiety
  • Pittsburg Sleep Quality Index [ Time Frame: 4 minutes ]
    Assess quality of sleep
  • Balance Master system [ Time Frame: 10 minutes ]
    Assess balance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Yoga Training in Ankylosing Spondylitis Patients
Official Title  ICMJE The Effects of Yoga Training in Ankylosing Spondylitis Patients
Brief Summary The aim of the study is to investigate the effect of yoga training on functional level, disease activity, spinal mobility, balance, sleep quality, depression and quality of life in AS patients.
Detailed Description

Yoga is an ancient Indian practice, dating back several thousand years, with objective of uniting mind, body, and spirit. In Western cultures, Hatha yoga is most commonly practiced, and generally includes a set of physical poses(asanas), breathing techniques(pranayama) and deep relaxation(savasana).Yoga has been shown to increase mobility, reduce pain, and improve quality of life in many diseases. However, there is no study examining the effects of yoga training in AS patients.Therefore, the aim of this study is to investigate the effects of yoga training in AS patients.

60 AS patients aged 20-60 years will be randomly assigned to yoga or control group. Home exercises will be taught to both groups, and a brochure with home exercises will be given. The yoga group will participate in a yoga class 3 days a week, during 8 weeks. The control group will not participate in a yoga class, only will do home exercises. Assessments will be done at baseline and after 8 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Ankylosing Spondylitis
  • Yoga
Intervention  ICMJE
  • Other: Yoga group
    Yoga training 3 days a week for 8 weeks. In addition to this, home exercises 5 days a week for 8 weeks
  • Other: Control group
    Home exercises 5 days a week for 8 weeks
Study Arms  ICMJE
  • Experimental: yoga group
    Participants in this group will be given yoga training 3 days a week for 8 weeks. In addition, patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks.
    Intervention: Other: Yoga group
  • Control group
    Patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks.
    Intervention: Other: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 20, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ankylosing spondylitis(AS) patients diagnosed according to modified New York criteria
  • To be volunteer

Exclusion Criteria:

  • the presence of peripheral enthesitis, orthopedic disorders, cardiovascular disorders, neurological disorders, visual and auditory deficits,
  • history of surgery for spine or lower limb,
  • failure to complete the test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04281238
Other Study ID Numbers  ICMJE 2019/07-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yasemin ACAR, Dokuz Eylul University
Study Sponsor  ICMJE Dokuz Eylul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dokuz Eylul University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP