Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Yoga Training in Ankylosing Spondylitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Yoga Other: Yoga group Other: Control group Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Yoga Training in Ankylosing Spondylitis Patients
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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
Control group
Patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks.
 Other: Control group
Home exercises 5 days a week for 8 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Short Form-36 (SF-36) [ Time Frame: 6 minutes ]
    Assess quality of life

  4. Beck Depression Inventory [ Time Frame: 5 minutes ]
    Assess depression

  5. Beck Anxiety Inventory [ Time Frame: 4 minutes ]
    Assess anxiety

  6. Pittsburgh Sleep Quality Index [ Time Frame: 4 minutes ]
    Assess quality of sleep

  7. Balance Master system [ Time Frame: 10 minutes ]
    Assess balance


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281238


Locations
Layout table for location information
Turkey
Dokuz Eylül University
İzmir, Eyalet/Yerleşke, Turkey, 35320
Sponsors and Collaborators
Dokuz Eylul University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yasemin ACAR, Research assistant, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT04281238    
Other Study ID Numbers: 2019/07-20
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasemin ACAR, Dokuz Eylul University:
ankylosing spondylitis
yoga
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis