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The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

Primary Purpose

Ankylosing Spondylitis, Yoga

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tele-yoga
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
  • 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

Sites / Locations

  • Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tele-Yoga Group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary 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.
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.
Assessment of Spondyloarthritis international Society Health Index (ASAS HI)
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
Muscular endurance:
Sit-up and push-up tests will be used to evaluate muscular endurance.
Balance
Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).
Aerobic Capacity
The incremental Shuttle Walk Test will be used to determine aerobic capacity
Pittsburgh Sleep Quality Index
Assess quality of sleep
The Hospital Anxiety And Depression Scale(HADS)
The HADS is a 14-item self-report questionnaire that measures anxiety (7 items) and depression (7 items) symptoms.
Stress
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.
Mindfulness
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.
Short Form-36 (SF-36)
Assess quality of life

Full Information

First Posted
March 11, 2021
Last Updated
May 30, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04803383
Brief Title
The Effects of Tele-Yoga in Ankylosing Spondylitis Patients
Official Title
The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

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
Yes

5. Study Description

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
Detailed Description
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.

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
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-Yoga Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tele-yoga
Intervention Description
Tele-yoga training 3 days a week for 8 weeks
Primary Outcome Measure Information:
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. Score range is 0-10, with 0 reflecting no functional impairments and 10 reflecting maximal impairment.
Time Frame
Change from Baseline at 8 weeks
Secondary 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
Change from Baseline at 8 weeks
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
Change from Baseline at 8 weeks
Title
Assessment of Spondyloarthritis international Society Health Index (ASAS HI)
Description
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
Time Frame
Change from Baseline at 8 weeks
Title
Muscular endurance:
Description
Sit-up and push-up tests will be used to evaluate muscular endurance.
Time Frame
Change from Baseline at 8 weeks
Title
Balance
Description
Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).
Time Frame
Change from Baseline at 8 weeks
Title
Aerobic Capacity
Description
The incremental Shuttle Walk Test will be used to determine aerobic capacity
Time Frame
Change from Baseline at 8 weeks
Title
Pittsburgh Sleep Quality Index
Description
Assess quality of sleep
Time Frame
Change from Baseline at 8 weeks
Title
The Hospital Anxiety And Depression Scale(HADS)
Description
The HADS is a 14-item self-report questionnaire that measures anxiety (7 items) and depression (7 items) symptoms.
Time Frame
Change from Baseline at 8 weeks
Title
Stress
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Mindfulness
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Short Form-36 (SF-36)
Description
Assess quality of life
Time Frame
Change from Baseline at 8 weeks

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YASEMİN ACAR
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
NURSEN İLÇİN
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
İSMAİL SARI
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Chair
Facility Information:
Facility Name
Dokuz Eylül University
City
İzmir
ZIP/Postal Code
35320
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

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