Rheumatoid Arthritis (RANCT07072754
Effectiveness of Yoga and Combined Exercise in Rheumatoid Arthritis
A study testing Mind-body therapy and Exercise in people with Rheumatoid Arthritis (RA, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to elucidate the potential benefits of exercise for individuals with rheumatoid arthritis. The findings are expected to contribute to the development of novel and effective therapeutic approaches, ultimately leading to an improved quality of life for patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- Mind-body therapy and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 May 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of RA for at least six months according to the ACR criteria
- aged between 18-65 years,
- under stabil medications at least four weeks
- the disease activity score 28 (DAS 28) <2.6 (Remission period) of each patient at least three months
- ability to provide written informed consent.
Who cannot join
- had pain that prevents general mobility,
- had neurologic, cardiologic (arrhythmias, myocardial infarction, uncontrolled metabolic disease,
- known electrolyte abnormalities,
- systolic BP > 200 mm Hg or diastolic BP > 115 mm Hg)
- respiratory pathology,
- pregnancy
- had malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Katip Celebi University Atatürk Education and Research Hospital
Izmir, Karabaglar, 35360
About this study
Official title: Effectiveness of Yoga and Combined Exercise in Female With Rheumatoid Arthritis: Randomized Controlled Trial
This study aims to elucidate the potential benefits of exercise for individuals with rheumatoid arthritis. The findings are expected to contribute to the development of novel and effective therapeutic approaches, ultimately leading to an improved quality of life for patients. For both patients and healthcare professionals, a clearer understanding of exercise's role in rheumatoid arthritis management will serve as a crucial guide in formulating individualized treatment plans. The results of our study will provide valuable insights to aid in developing strategies aimed at enhancing the physical and mental well-being of individuals afflicted with rheumatoid arthritis.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory disease that significantly impacts daily life by causing pain, swelling, and restricted movement in the joints. This study aimed to investigate the effects of yoga and combined exercise methods on the symptoms of RA in individuals with the condition, comparing them to a control group that did not engage in exercise. Participants were comprehensively evaluated at baseline, week 8, and week 20 for key variables such as pain level, balance, joint mobility, depression level, fatigue level, and quality of life. This research seeks to reveal the potential benefits of exercise in RA management, thereby contributing to the development of effective treatment approaches that improve patients' quality of life. The findings will help both patients and healthcare professionals better understand the role of exercise in RA treatment, serving as a crucial guide for creating individualized treatment plans. The results are expected to offer valuable insights for developing strategies to enhance the physical and mental health of individuals with RA.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- Mind-body therapy, Exercise
- Keywords
- rheumatoid arthritis, yoga, combined exercise, pain
- Medical subject headings
- Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body therapyOther
Also called Yoga
The yoga program, led by a physiotherapist who is also a certified yoga instructor , with two sessions per week lasting one hour each. Foam yoga blocks, belts, and armless chairs were also available in the classes, where the participants were to support compliance with the program. The yoga program was planned as 10 minutes of centering and breathing practice, 10 minutes of warm-up practice, 30 minutes of supine, standing, sitting, prone, and supine yoga postures, and 10 minutes of relaxation. New postures were introduced every two weeks as the program progressed. After the eight-week session, the participants were encouraged to continue the program at home twice a week
ExerciseOther
Patients in the exercise group were given a program that included warm-up, low-impact aerobic, strengthening, and cooling phases, totaling 60 minutes, repeated twice a week for eight weeks. Aerobic exercise was performed by standing still for 25 minutes at moderate intensity based on perceived effort. Strengthening exercises included one set of 10 repetitions for each movement. Exercises were progressed according to the modified Borg's scale. Strengthening exercises included core muscles such as the deltoid, abdominals, quadriceps femoris, and hamstrings and were performed using body weight or elastic resistance bands
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | The yoga program, led by a physiotherapist who is also a certified yoga instructor , with two sessions per week lasting one hour each. It was applied for a total of 8 weeks. Receives: Other: Mind-body therapy |
| Combined Exercise | Experimental | Patients in the exercise group were given a program that included warm-up, low-impact aerobic, strengthening, and cooling phases, totaling 60 minutes, repeated twice a week for eight weeks. Receives: Other: Exercise |
| Control | No intervention | No exercise was applied to the subjects included in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The Visual Analogue Scale (VAS) was used for pain intensity assessment in all patients. The scale is a 10-cm line, with the leftmost part showing no pain and the rightmost part showing maximum pain. Patients were asked to point to the proper place on the line according to the pain they experienced last week. An increase of 20% or above indicates clinical significance in VAS.
Measured: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
Secondary outcomes (5)
Balance Index
The Berg Balance Scale (BBS) was used to evaluate the functional balance status. It is a 14-item test of functional balance. Each item is scored between 0-4, with a maximum score of 56. Higher scores represent a good balance level. It assesses static balance during standing and sitting and dynamic balance during walking. The Turkish validity and reliability of the scale were conducted by Sahin et. al.
Measured: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
Mobility Level
The Timed Up and Go test (TUG) was also used to evaluate the balance and mobility of the patients. This test is used to measure walking speed and evaluate balance, physical mobility, and the ability to go outside alone. For the TUG test, patients were asked to stand up from a chair with armrests, to walk 3 meters, to turn and walk back to the chair, and to sit down again to the chair. The time it took to complete the test was recorded using the electronic stopwatch. The minimum clinical significance of TUG was given as a decrease of 1.14 seconds.
Measured: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
Depression Level
The severity of depression was evaluated using the Beck Depression Inventory Scale (BDI), which has 21 items and a total score of 63. The cut-off scores for the RA population revealed 0-12 for minimal, 13-18 for mild, 19-28 for moderate, and 29-63 for severe depression. The Turkish validity and reliability of the scale were conducted by Hisli et. al..
Measured: From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline
Fatigue Level
The Fatigue Severity Scale (FSS) was used to measure the impact of fatigue on patients. It contains nine statements, rated on a Likert scale of 1 to 7, where 1 indicates completely disagree, and 7 indicates agree entirely. Higher scores indicate higher fatigue levels. In a study conducted on systemic lupus patients, the minimum clinical significance of FSS was given as a decrease of 0.6 points or more. The Turkish validity and reliability of the scale were conducted by Gencay-Can.
Measured: From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline
Quality of Life Level
Short Form 36 (SF-36) was used to assess health-related quality of life. The SF-36 is a widely applied generic instrument for measuring health status and consists of eight dimensions: physical functioning, social functioning, physical role, emotional role, mental health, vitality, bodily pain, and general health perceptions. Scores range from 0 (worst) to 100 (best), with higher scores indicating better health status. The Turkish validity and reliability of the scale were conducted by Bilir Kaya et. al.
Measured: From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Feb 2018
- Primary completion1 Mar 2019
- Study completion1 May 2023
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 Rheumatoid Arthritis (RAStudies 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
- Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevtap Günay, Izmir Katip Celebi University
- Investigators
- Elif Umay Altas, Associate Professor Doctor, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072754
- Sponsor's protocol ID
- Rheumatoid Arthritis and Yoga
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data will not be shared. All data will be shared blindly by special request, provided that a valid reason is given.
Publications
Umay Altas E, Gunay Ucurum S, Polat K, Bolel O, Bal S. Effectiveness of Yoga and Combined Exercise in Female With Rheumatoid Arthritis: Randomized Controlled Trial. Musculoskeletal Care. 2026 Sep;24(3):e70261. doi: 10.1002/msc.70261.
PubMed 42661382
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Yoga and Combined Exercise in Female With Rheumatoid Arthritis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07072754
- Acronym / sponsor ID
- Rheumatoid Arthritis and Yoga
- Conditions
- Rheumatoid Arthritis (RA
- Keywords
- rheumatoid arthritis, yoga, combined exercise, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 18 Jul 2025 (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.
This study aims to elucidate the potential benefits of exercise for individuals with rheumatoid arthritis. The findings are expected to contribute to the development of novel and effective therapeutic approaches, ultimately leading to an improved quality of life for patients. For both patients and healthcare professionals, a clearer understanding of exercise's role in rheumatoid arthritis management will serve as a crucial guide in formulating individualized treatment plans. The results of our study will provide valuable insights to aid in developing strategies aimed at enhancing the physical and mental well-being of individuals afflicted with rheumatoid arthritis.
Detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory disease that significantly impacts daily life by causing pain, swelling, and restricted movement in the joints. This study aimed to investigate the effects of yoga and combined exercise methods on the symptoms of RA in individuals with the condition, comparing them to a control group that did not engage in exercise. Participants were comprehensively evaluated at baseline, week 8, and week 20 for key variables such as pain level, balance, joint mobility, depression level, fatigue level, and quality of life. This research seeks to reveal the potential benefits of exercise in RA management, thereby contributing to the development of effective treatment approaches that improve patients' quality of life. The findings will help both patients and healthcare professionals better understand the role of exercise in RA treatment, serving as a crucial guide for creating individualized treatment plans. The results are expected to offer valuable insights for developing strategies to enhance the physical and mental health of individuals with RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: Mind-body therapyThe yoga program, led by a physiotherapist who is also a certified yoga instructor , with two sessions per week lasting one hour each. It was applied for a total of 8 weeks. |
| Combined Exercise | Experimental | Other: ExercisePatients in the exercise group were given a program that included warm-up, low-impact aerobic, strengthening, and cooling phases, totaling 60 minutes, repeated twice a week for eight weeks. |
| Control | No intervention | –No exercise was applied to the subjects included in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of RA for at least six months according to the ACR criteria
- aged between 18-65 years,
- under stabil medications at least four weeks
- the disease activity score 28 (DAS 28) <2.6 (Remission period) of each patient at least three months
- ability to provide written informed consent.
Key exclusion criteria (7 listed)
- had pain that prevents general mobility,
- had neurologic, cardiologic (arrhythmias, myocardial infarction, uncontrolled metabolic disease,
- known electrolyte abnormalities,
- systolic BP > 200 mm Hg or diastolic BP > 115 mm Hg)
- respiratory pathology,
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 |
|---|---|---|
| Mind-body therapyAlso: YogaThe yoga program, led by a physiotherapist who is also a certified yoga instructor , with two sessions per week lasting one hour each. Foam yoga blocks, belts, and armless chairs were also available in the classes, where the participants were to support compliance with the program. The yoga program was planned as 10 minutes of centering and breathing practice, 10 minutes of warm-up practice, 30 minutes of supine, standing, sitting, prone, and supine yoga postures, and 10 minutes of relaxation. New postures were introduced every two weeks as the program progressed. After the eight-week session, the participants were encouraged to continue the program at home twice a week | Other | Yoga |
| ExercisePatients in the exercise group were given a program that included warm-up, low-impact aerobic, strengthening, and cooling phases, totaling 60 minutes, repeated twice a week for eight weeks. Aerobic exercise was performed by standing still for 25 minutes at moderate intensity based on perceived effort. Strengthening exercises included one set of 10 repetitions for each movement. Exercises were progressed according to the modified Borg's scale. Strengthening exercises included core muscles such as the deltoid, abdominals, quadriceps femoris, and hamstrings and were performed using body weight or elastic resistance bands | Other | Combined Exercise |
Primary outcome
Pain Intensity
Time frame: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
The Visual Analogue Scale (VAS) was used for pain intensity assessment in all patients. The scale is a 10-cm line, with the leftmost part showing no pain and the rightmost part showing maximum pain. Patients were asked to point to the proper place on the line according to the pain they experienced last week. An increase of 20% or above indicates clinical significance in VAS.
5 secondary outcomes
Balance Index
Time frame: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
Mobility Level
Time frame: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
Depression Level
Time frame: From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline
Fatigue Level
Time frame: From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline
Quality of Life Level
Time frame: From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline
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 18 Jul 2025.
- Derived from this study: PubMed 42661382Umay Altas E, Gunay Ucurum S, Polat K, Bolel O, Bal S. Effectiveness of Yoga and Combined Exercise in Female With Rheumatoid Arthritis: Randomized Controlled Trial. Musculoskeletal Care. 2026 Sep;24(3):e70261. doi: 10.1002/msc.70261.
- Individual participant dataSharing planned: No. Personal data will not be shared. All data will be shared blindly by special request, provided that a valid reason is given.
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.
Elif Umay Altas, Associate Professor Doctor principal investigator
Izmir Bakircay 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 Mind-body therapy and Exercise in people with Rheumatoid Arthritis (RA, run by Izmir Katip Celebi 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 5 inclusion and 7 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 18 Jul 2025. 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?
Pain Intensity (time frame: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline). 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 NCT07072754, 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 18 Jul 2025.