Ankylosing SpondylitisNCT04281238
The Effects of Yoga Training in Ankylosing Spondylitis Patients
A study testing Yoga group in people with Ankylosing Spondylitis and Yoga, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. 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?
- Yoga group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2020to Dec 2021
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylül University
Izmir, Eyalet/Yerleşke, 35320
About this study
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.
Read the 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.
- Conditions
- Ankylosing Spondylitis, Yoga
- Being tested
- Yoga group, Control group
- 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.
Yoga groupOther
Yoga training 3 days a week for 8 weeks. In addition to this, home exercises 5 days a week for 8 weeks
Control groupOther
Home exercises 5 days a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| yoga group | Experimental | 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. Receives: Other: Yoga group |
| Control group | Other | Patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 5 minutes
Secondary outcomes (7)
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: 2 minutes
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.
Measured: 3 minutes
Short Form-36 (SF-36)
Assess quality of life
Measured: 6 minutes
Beck Depression Inventory
Assess depression
Measured: 5 minutes
Beck Anxiety Inventory
Assess anxiety
Measured: 4 minutes
Pittsburgh Sleep Quality Index
Assess quality of sleep
Measured: 4 minutes
Balance Master system
Assess balance
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start26 Oct 2020
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Because of Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ACAR, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281238
- Sponsor's protocol ID
- 2019/07-20
- Status last verified
- Jan 2021
- First submitted
- 20 Feb 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga Training in Ankylosing Spondylitis Patients
- ClinicalTrials.gov ID
- NCT04281238
- Acronym / sponsor ID
- 2019/07-20
- Conditions
- Ankylosing Spondylitis, Yoga
- Keywords
- ankylosing spondylitis, yoga
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Because of Covid-19
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Feb 2020 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga group | Experimental | Other: Yoga groupParticipants 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. |
| Control group | Other | Other: Control groupPatients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ankylosing spondylitis(AS) patients diagnosed according to modified New York criteria
- To be volunteer
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Yoga groupYoga training 3 days a week for 8 weeks. In addition to this, home exercises 5 days a week for 8 weeks | Other | yoga group |
| Control groupHome exercises 5 days a week for 8 weeks | Other | Control group |
Primary outcome
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.
7 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 2 minutes
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 3 minutes
Short Form-36 (SF-36)
Time frame: 6 minutes
Beck Depression Inventory
Time frame: 5 minutes
Beck Anxiety Inventory
Time frame: 4 minutes
Pittsburgh Sleep Quality Index
Time frame: 4 minutes
Balance Master system
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga group 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 2 inclusion and 3 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: paused, as of the sponsor's last update on 12 Jan 2021. 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?
Results are not available in the source record.
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 Spinal Metrology Index (BASMI) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2021.