Spondylitis, AnkylosingNCT03807180
Effects of Tai Chi in Patients With Ankylosing Spondylitis Receiving Anti-tumor Necrosis Factor Alpha Therapy
A study testing Tai Chi (exercise) in people with Spondylitis, Ankylosing, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Ankylosing Spondylitis (AS) is a chronic inflammatory rheumatic disease that causes a decrease in physical activity, fatigue, sleep problems and psychological consequences such as depression, anxiety and stress by primarily affecting the sacroiliac joint and spine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Tai Chi (exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2019to 30 Apr 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being sedentary (not routinely involved in exercise activities during the last 3 months).
- We have been using fixed dose medication for at least 6 months (no change in drug treatment during the study).
- No communication problem
Who cannot join
- Functional disorders more effective than ankylosing spondylitis;
- Diastolic heart failure
- Renal failure
- Severe asthma knee osteoarthritis
- Metastatic prostate cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Education and Research Hospital
Antalya, Konyaalti, 07070
About this study
Official title: Tai Chi in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis (AS) is a chronic inflammatory rheumatic disease that causes a decrease in physical activity, fatigue, sleep problems and psychological consequences such as depression, anxiety and stress by primarily affecting the sacroiliac joint and spine. The aim of the treatment of AS is to prevent the hardness and flexion deformity associated with the disease; to maintain the patient's healthy psychological and physical condition. The first step in the treatment of AS; Pharmacological treatment of NSAIDs or Anti-TNFs along with exercise. Exercise, especially pain and immobility symptoms control provides patients with disease is an advantage.
Tai Chi Chuan or Taiji is a traditional Chinese exercise method that has been applied for more than 300 years. Exercises based on Chinese medicine and martial arts. It is a combination of physical exercise and relaxation techniques and is used to improve the mental and physical health of individuals. In literature, balance, strength, coordination, postural control, agility, reaction time, flexibility has attracted attention for developing such factors. In addition, it increases muscle strength in elderly people and decreases the risk of falling; Rheumatoid arthritis and Osteoarthritis-related symptoms have been reported to improve in a positive way. In the literature, there is only one study examining the efficacy of Tai Chi in AS patients. According to the results of this study, Tai Chi has a positive effect on disease activity and flexibility of patients with AS.
Read more
Although there is consensus on exercise role in the treatment of AS, when the literature is reviewed, it is seen that the strict and definite guidelines on the type and frequency of exercises are not yet described. There is no defined protocol for which specific exercise is appropriate in AS. The literature considers that more information is needed on the various physical therapy programs related to intensity, frequency and duration to determine the most appropriate activity for the disease.
The aim of this study was to investigate the effect of Tai Chi exercises on functionality, disease activity, functional exercise capacity, spinal mobility, lower extremity strength and quality of life in AS patients with biological agents.
Read the detailed description
At least 36 AS patients followed-up by Antalya Training and Research Hospital, who are receiving Anti-TNF therapy and who do not have any other disease affecting their functions will be included in the study. There were 18 patients in the conventional treatment group and 18 patients in the Tai Chi group.
After the demographic data of AS patients were recorded, Bath AS Disease Activity Index (BASDAI), Bath AS Disease Activity Index (BASFI) and Bath AS Metrology Index (BASMI), respectively, to be used for activity and basic measurements of the disease, 6 minutes walking test to measure aerobic capacity , Cognitive Exercise Therapy Approach Scale and Ankylosing Spondylitis Quality of Life Questionnaire to be used for quality of life, 30 second sit-down test to evaluate the lower extremity strength. In addition, 10-20 ml (1-2 tubes) of blood will be taken from the patient's arm, the amount of substances such as erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) in the blood will be measured. Patients will not be charged any fee related to this process. Evaluation methods will be applied to the cases before the start of training and after the completion of the training.
For the training, both patient groups were randomly divided into two groups: the first group was treated with conventional treatment and the second group with Tai Chi training. The training will last 10 weeks.
Conventional treatment; stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls.
Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total.
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Tai Chi (exercise)
- Keywords
- Tai Chi, ankylosing spondylitis, functionality
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi (exercise)Other
Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases.
| Study group | Role | What they receive |
|---|---|---|
| Group of Tai Chi | Other | Group of Tai Chi intervention include 18 patients with AS. Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total. Receives: Other: Tai Chi (exercise) |
| Group of control | No intervention | Conventional exercises are stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath Ankylosing Spondylitis Functional Index (BASFI)
This self-assessment instrument was designed by a team of medical professionals in conjunction with patients, and consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher scores show poor functionality.
Measured: ten weeks
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The index, designed by a multidisciplinary team with input from patients, consists of six 10 cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. Higher scores show poor disease activity.
Measured: ten weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
İt is for quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement.It is included of clinical measures of cervical rotation, tragus to wall distance, lumbar flexion, lumbar side flexion, and intermalleolar distance.Each item is scored from 0-10 based on individually defined cut points. Ranges are given as cervical rotation (>85.0° to ≤8.5°), tragus to wall (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Higher scores show poor spinal mobility.
Measured: ten weeks
Secondary outcomes (2)
Ankylosing Spondylitis Life Quality Questionnaire (ASQol),
It is purpose to measure the impact of ankylosing spondylitis (AS) on health-related quality of life from the patient's perspective.The questionnaire includes items related to the impact of disease on sleep, mood, motivation, coping, activities of daily living, independence, relationships, and social life. It is included 18 items.Dichotomous responses, with 0 scored for a "no" and 1 scored for a "yes" for each item. Total score is the sum of the individual responses.Score range is 0-18, with higher scores reflecting greater impairment of health-related quality of life.
Measured: ten weeks
6 minute walking test
The maximum distance that individuals can walk in a 30-meter straight and inclined corridor for 6 minutes is recorded. Higher distances show better aerobic capacity
Measured: ten week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start25 Jan 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
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 Spondylitis, AnkylosingStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Basakci Calik, Pamukkale University
- Investigators
- Ayse Ayan, Dr, Study chair, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807180
- Sponsor's protocol ID
- 60116787-020/55441
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will use Statistical package for the social sciences (SPSS) for participant data after interventions
Publications
Lee EN, Kim YH, Chung WT, Lee MS. Tai chi for disease activity and flexibility in patients with ankylosing spondylitis--a controlled clinical trial. Evid Based Complement Alternat Med. 2008 Dec;5(4):457-62. doi: 10.1093/ecam/nem048. Epub 2007 Jul 13.
PubMed 18955296
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT03807180
- Acronym / sponsor ID
- 60116787-020/55441
- Conditions
- Spondylitis, Ankylosing
- Keywords
- Tai Chi, ankylosing spondylitis, functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 16 Jan 2019 (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.
Ankylosing Spondylitis (AS) is a chronic inflammatory rheumatic disease that causes a decrease in physical activity, fatigue, sleep problems and psychological consequences such as depression, anxiety and stress by primarily affecting the sacroiliac joint and spine. The aim of the treatment of AS is to prevent the hardness and flexion deformity associated with the disease; to maintain the patient's healthy psychological and physical condition. The first step in the treatment of AS; Pharmacological treatment of NSAIDs or Anti-TNFs along with exercise. Exercise, especially pain and immobility symptoms control provides patients with disease is an advantage.
Tai Chi Chuan or Taiji is a traditional Chinese exercise method that has been applied for more than 300 years. Exercises based on Chinese medicine and martial arts. It is a combination of physical exercise and relaxation techniques and is used to improve the mental and physical health of individuals. In literature, balance, strength, coordination, postural control, agility, reaction time, flexibility has attracted attention for developing such factors. In addition, it increases muscle strength in elderly people and decreases the risk of falling; Rheumatoid arthritis and Osteoarthritis-related symptoms have been reported to improve in a positive way. In the literature, there is only one study examining the efficacy of Tai Chi in AS patients. According to the results of this study, Tai Chi has a positive effect on disease activity and flexibility of patients with AS.
Although there is consensus on exercise role in the treatment of AS, when the literature is reviewed, it is seen that the strict and definite guidelines on the type and frequency of exercises are not yet described. There is no defined protocol for which specific exercise is appropriate in AS. The literature considers that more information is needed on the various physical therapy programs related to intensity, frequency and duration to determine the most appropriate activity for the disease.
The aim of this study was to investigate the effect of Tai Chi exercises on functionality, disease activity, functional exercise capacity, spinal mobility, lower extremity strength and quality of life in AS patients with biological agents.
Detailed description
At least 36 AS patients followed-up by Antalya Training and Research Hospital, who are receiving Anti-TNF therapy and who do not have any other disease affecting their functions will be included in the study. There were 18 patients in the conventional treatment group and 18 patients in the Tai Chi group.
After the demographic data of AS patients were recorded, Bath AS Disease Activity Index (BASDAI), Bath AS Disease Activity Index (BASFI) and Bath AS Metrology Index (BASMI), respectively, to be used for activity and basic measurements of the disease, 6 minutes walking test to measure aerobic capacity , Cognitive Exercise Therapy Approach Scale and Ankylosing Spondylitis Quality of Life Questionnaire to be used for quality of life, 30 second sit-down test to evaluate the lower extremity strength. In addition, 10-20 ml (1-2 tubes) of blood will be taken from the patient's arm, the amount of substances such as erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) in the blood will be measured. Patients will not be charged any fee related to this process. Evaluation methods will be applied to the cases before the start of training and after the completion of the training.
For the training, both patient groups were randomly divided into two groups: the first group was treated with conventional treatment and the second group with Tai Chi training. The training will last 10 weeks.
Conventional treatment; stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls.
Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Group of Tai Chi | Other | Other: Tai Chi (exercise)Group of Tai Chi intervention include 18 patients with AS. Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques, will be applied by an experienced physiotherapist who is trained with Tai Chi. The training will take 60 minutes, 2 days a week and 10 weeks in total. |
| Group of control | No intervention | –Conventional exercises are stretching for the cervical, thoracic and lumbar flexibility, shoulder circumference, hamstring and erector spinal muscles, strengthening exercises for abdominal, back and proximal muscles. The exercises that will be taught in detail to each stage of the patient will be performed at home by the patient for 60 minutes, 2 days a week. The patients will be inspected and controlled by monthly controls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being sedentary (not routinely involved in exercise activities during the last 3 months).
- We have been using fixed dose medication for at least 6 months (no change in drug treatment during the study).
- No communication problem
Key exclusion criteria (5 listed)
- Functional disorders more effective than ankylosing spondylitis;
- Diastolic heart failure
- Renal failure
- Severe asthma knee osteoarthritis
- Metastatic prostate cancer
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 |
|---|---|---|
| Tai Chi (exercise)Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases. | Other | Group of Tai Chi |
Primary outcome
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: ten weeks
This self-assessment instrument was designed by a team of medical professionals in conjunction with patients, and consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher scores show poor functionality.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: ten weeks
The index, designed by a multidisciplinary team with input from patients, consists of six 10 cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. Higher scores show poor disease activity.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: ten weeks
İt is for quantify the mobility of the axial skeleton in ankylosing spondylitis (AS) patients and allow objective assessment of clinically significant changes in spinal movement.It is included of clinical measures of cervical rotation, tragus to wall distance, lumbar flexion, lumbar side flexion, and intermalleolar distance.Each item is scored from 0-10 based on individually defined cut points. Ranges are given as cervical rotation (>85.0° to ≤8.5°), tragus to wall (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Higher scores show poor spinal mobility.
2 secondary outcomes
Ankylosing Spondylitis Life Quality Questionnaire (ASQol),
Time frame: ten weeks
6 minute walking test
Time frame: ten week
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 14 Jan 2020.
- Results publication: PubMed 18955296Lee EN, Kim YH, Chung WT, Lee MS. Tai chi for disease activity and flexibility in patients with ankylosing spondylitis--a controlled clinical trial. Evid Based Complement Alternat Med. 2008 Dec;5(4):457-62. doi: 10.1093/ecam/nem048. Epub 2007 Jul 13.
- Individual participant dataSharing planned: No. We will use Statistical package for the social sciences (SPSS) for participant data after interventions
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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.
Ayse Ayan, Dr study chair
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi (exercise) in people with Spondylitis, Ankylosing, run by Pamukkale 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 5 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 14 Jan 2020. 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: ten weeks). The study lists 3 primary outcomes in all. 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 NCT03807180, 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 14 Jan 2020.