search
Back to results

The Effects of Yoga Training in Ankylosing Spondylitis Patients

Primary Purpose

Ankylosing Spondylitis, Yoga

Status
Suspended
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yoga group
Control group
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, yoga

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

yoga group

Control group

Arm Description

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.

Patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks.

Outcomes

Primary Outcome Measures

Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)
Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility.

Secondary Outcome Measures

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.
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.
Short Form-36 (SF-36)
Assess quality of life
Beck Depression Inventory
Assess depression
Beck Anxiety Inventory
Assess anxiety
Pittsburgh Sleep Quality Index
Assess quality of sleep
Balance Master system
Assess balance

Full Information

First Posted
February 20, 2020
Last Updated
January 8, 2021
Sponsor
Dokuz Eylul University
search

1. Study Identification

Unique Protocol Identification Number
NCT04281238
Brief Title
The Effects of Yoga Training in Ankylosing Spondylitis Patients
Official Title
The Effects of Yoga Training in Ankylosing Spondylitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Suspended
Why Stopped
Because of Covid-19
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis, Yoga
Keywords
ankylosing spondylitis, yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
yoga group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Yoga group
Intervention Description
Yoga training 3 days a week for 8 weeks. In addition to this, home exercises 5 days a week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Home exercises 5 days a week for 8 weeks
Primary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)
Description
Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
Assess disease activity. The total score ranges from 0 to 10. High scores mean an increase in disease activity.
Time Frame
2 minutes
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
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.
Time Frame
3 minutes
Title
Short Form-36 (SF-36)
Description
Assess quality of life
Time Frame
6 minutes
Title
Beck Depression Inventory
Description
Assess depression
Time Frame
5 minutes
Title
Beck Anxiety Inventory
Description
Assess anxiety
Time Frame
4 minutes
Title
Pittsburgh Sleep Quality Index
Description
Assess quality of sleep
Time Frame
4 minutes
Title
Balance Master system
Description
Assess balance
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dokuz Eylül University
City
İzmir
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
35320
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Effects of Yoga Training in Ankylosing Spondylitis Patients

We'll reach out to this number within 24 hrs