Ankylosing SpondylitisNCT04803383
The Effects of Tele-Yoga in Ankylosing Spondylitis Patients
A study testing Tele-yoga in people with Ankylosing Spondylitis and Yoga, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ankylosing Spondylitis, Yoga
- What is being tested?
- Tele-yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial
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
Read the 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.
- Conditions
- Ankylosing Spondylitis, Yoga
- Being tested
- Tele-yoga
- Keywords
- ankylosing spondylitis, yoga
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-yogaOther
Tele-yoga training 3 days a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tele-Yoga Group | Experimental | 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 Receives: Other: Tele-yoga |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (11)
Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)
Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility.
Measured: Change from Baseline at 8 weeks
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.
Measured: Change from Baseline at 8 weeks
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
Measured: Change from Baseline at 8 weeks
Muscular endurance:
Sit-up and push-up tests will be used to evaluate muscular endurance.
Measured: Change from Baseline at 8 weeks
Balance
Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).
Measured: Change from Baseline at 8 weeks
Aerobic Capacity
The incremental Shuttle Walk Test will be used to determine aerobic capacity
Measured: Change from Baseline at 8 weeks
Pittsburgh Sleep Quality Index
Assess quality of sleep
Measured: Change from Baseline at 8 weeks
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.
Measured: Change from Baseline at 8 weeks
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.
Measured: Change from Baseline at 8 weeks
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.
Measured: Change from Baseline at 8 weeks
Short Form-36 (SF-36)
Assess quality of life
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start14 Apr 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ACAR, Dokuz Eylul University
- Investigators
- YASEMİN ACAR, Principal investigator, Dokuz Eylul UniversityNURSEN İLÇİN, Study director, Dokuz Eylul UniversityİSMAİL SARI, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803383
- Sponsor's protocol ID
- 2021/05-34
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acar Y, Ilcin N, Sari I. The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial. J Integr Complement Med. 2023 Nov;29(11):727-737. doi: 10.1089/jicm.2023.0022. Epub 2023 May 31.
PubMed 37257184
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04803383
- Acronym / sponsor ID
- 2021/05-34
- Conditions
- Ankylosing Spondylitis, Yoga
- Keywords
- ankylosing spondylitis, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tele-Yoga Group | Experimental | Other: Tele-yogaPatients 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 |
| Control group | No intervention | –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 may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-yogaTele-yoga training 3 days a week for 8 weeks | Other | Tele-Yoga Group |
Primary outcome
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.
11 secondary outcomes
Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)
Time frame: Change from Baseline at 8 weeks
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Change from Baseline at 8 weeks
Assessment of Spondyloarthritis international Society Health Index (ASAS HI)
Time frame: Change from Baseline at 8 weeks
Muscular endurance:
Time frame: Change from Baseline at 8 weeks
Balance
Time frame: Change from Baseline at 8 weeks
Aerobic Capacity
Time frame: Change from Baseline at 8 weeks
Pittsburgh Sleep Quality Index
Time frame: Change from Baseline at 8 weeks
The Hospital Anxiety And Depression Scale(HADS)
Time frame: Change from Baseline at 8 weeks
Stress
Time frame: Change from Baseline at 8 weeks
Mindfulness
Time frame: Change from Baseline at 8 weeks
Short Form-36 (SF-36)
Time frame: Change from Baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 37257184Acar Y, Ilcin N, Sari I. The Effects of Tele-Yoga in Ankylosing Spondylitis Patients: A Randomized Controlled Trial. J Integr Complement Med. 2023 Nov;29(11):727-737. doi: 10.1089/jicm.2023.0022. Epub 2023 May 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YASEMİN ACAR principal investigator
Dokuz Eylul University
NURSEN İLÇİN study director
Dokuz Eylul University
İSMAİL SARI study chair
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-yoga in people with Ankylosing Spondylitis and Yoga, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bath Ankylosing Spondylitis Functional Index (BASFI) (time frame: Change from Baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.