- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07072754
- Original Trial
Effectiveness of Yoga and Combined Exercise in Rheumatoid Arthritis
July 9, 2025 updated by: Sevtap Günay, Izmir Katip Celebi University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karabaglar
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İzmir, Karabaglar, Turkey, 35360
- Katip Celebi University Atatürk Education and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga
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.
|
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
Other Names:
|
|
Experimental: Combined Exercise
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.
|
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
|
|
No Intervention: Control
No exercise was applied to the subjects included in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Index
Time Frame: From enrollment to the end of treatment at 8 weeks and 20 weeks after baseline
|
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.
|
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
|
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.
|
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
|
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..
|
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
|
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.
|
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
|
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.
|
From enrollment to the end of treatment at 8 weeks and 20 weeks later baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elif Umay Altas, Associate Professor Doctor, Izmir Bakircay University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
May 1, 2023
Study Registration Dates
First Submitted
July 9, 2025
First Submitted That Met QC Criteria
July 9, 2025
First Posted (Estimated)
July 18, 2025
Study Record Updates
Last Update Posted (Estimated)
July 18, 2025
Last Update Submitted That Met QC Criteria
July 9, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rheumatoid Arthritis and Yoga
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Personal data will not be shared.
All data will be shared blindly by special request, provided that a valid reason is given.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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