Rheumatoid ArthritisNCT03836820
Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
A study testing Clinical pilates exercise, Aerobic exercise and Clinical Pilates and Aerobic Exercise in people with Rheumatoid Arthritis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis. Articular and extraarticular sympthoms are mostly seen in patients with RA. Additionally, extra complaints such as depression, fatigue, kinesiophobia and physical inactivity may accompany. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Clinical pilates exercise, Aerobic exercise and Clinical Pilates and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2018to Oct 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
- Patients between the ages of 18 to 65 and who have diagnosed with RA according to American College of Rheumatology criteria will be included the study.
Who cannot join
- Patients who were pregnant, diagnosed with malignancy, had changes of medical treatment in the last 3 months, had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits, had regular exercise habit (minimally three days in a week), had high disease activity score (DAS-28>3.2) and had cardiac symphtoms according to New YorkHeart Association will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara, 06560
Songul Baglan Yentur
Nuh Atas
About this study
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis. Articular and extraarticular sympthoms are mostly seen in patients with RA. Additionally, extra complaints such as depression, fatigue, kinesiophobia and physical inactivity may accompany. Positive effects of physical activity and exercise are known. In some studies, effects of pilates exercises have been investigated on many different diseases such as Multiple Sclerosis, Ankylosing Spondylitis and breast cancer. The aim of this study is to investigate effects of clinical pilates exercises on fatigue, depression, aerobic capacity, pain, quality of life, disease activity and sleep quality.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis and is associated with progressive impairments and activity limitations. It may cause destruction of bone and cartilage by affecting synovial joints symmetrically. Organ involvement may be seen in the patients with RA as well as joint involvement. Initiation of the disease is mostly insidious and varies from patient to patient. Hand, wrist, foot, elbow and knee joints involvement are common. Furthermore almost all joints may be affected. Extraarticular symptoms are subcutaneous nodules, visceral nodules, cardiologic involvement, pulmonary involvement, eye involvement, neurological involvement, vasculitis, felty syndrome, amyloidosis, osteoporosis, liver and renal involvements. These symptoms may cause some extra complaints such as depression, fatigue, kinesiophobia and physical inactivity. Studies in literature have reported reduction in physical activity level in patients with RA. Reasons of physical inactivity can be listed as general obstacles such as lack of time, lack of motivation, weather condition and disease related blocks such as pain, fatigue, disease activity, depression, kinesiophobia. Depression prevalence in RA patients is found between 14.8% and 38.8% and this rate is estimated five times more than healthy people. Also, a study investigating pain in RA patients resulted that pain may be correlated with fatigue and depression. Fatigue which is frequently observed complaint of patients with rheumatic diseases is reported incidence between 40% and 80%. RA patients have been reported at high risk for cardiovascular diseases in EULAR recommendations.
Positive effects of physical activity and exercise on physiological, morphological and psychosocial conditions are known. Endurance, flexibility, muscle strength, body composition, self confidence and mood improve by regular exercise and high physical activity level. Furthermore, anti-inflammatory affects of exercise are proved in last years. Aims of pilates exercises which are developed by Joseph Pilates are to increase motor control, range of motion, flexibility, muscle strength and endurance, to improve balance, respiratory pattern and body awareness, to reduce stress. There are many studies investigating affects of pilates exercises on quality of life, functional capacity, posture, pain for different diseases including Multiple Sclerosis, Ankylosing Spondylitis, breast cancer. Aerobic and strengthening exercises reported to have positive affects on fatigue, quality of life, depression and pain for RA patients. The aim of this study is to investigate effects of clinical pilates exercises on fatigue, depression, aerobic capacity, pain, quality of life, disease activity and sleep quality.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Clinical pilates exercise, Aerobic exercise, Clinical Pilates and Aerobic Exercise
- Keywords
- Rheumatoid Arhritis, Pilates exercises, Fatigue
- Medical subject headings
- Arthritis, Rheumatoid, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pilates exerciseOther
Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Aerobic exerciseOther
Progressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks.
Clinical Pilates and Aerobic ExerciseOther
Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Clinical pilates exercise | Experimental | Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. Receives: Other: Clinical pilates exercise; Other: Clinical Pilates and Aerobic Exercise |
| Aerobic exercise | Experimental | Progressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks. Receives: Other: Aerobic exercise; Other: Clinical Pilates and Aerobic Exercise |
| Clinical pilates and Aerobic exercise | Experimental | Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks. Receives: Other: Clinical pilates exercise; Other: Aerobic exercise; Other: Clinical Pilates and Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
The 6-minute walk test is a submaximal exercise test used to quantify the functional exercise capacity in clinical populations. It measures the distance walked within a period of 6-minutes.
Measured: 6 minutes
Fatigue severity scale
Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7
Measured: 2 minutes
Secondary outcomes (5)
Beck Depression Inventory
The Beck Depression Inventory (BDI) is world-wide among the most used selfrating scales for measuring depression. BDI consists of 21 items related to depressive symptoms such as pessimism, sense of failure, guilt, dissatisfaction, sleep, appetite and fatigue. Each item is scored between 0 and 3. Total score is 63, and an increase of the score means increased severity of depression. According to this scale 1-10 points are defined as normal, scores between 11-16 indicate mild mental distress, 17-20 indicate the patient is at the border points for clinical depression, 21-30 indicate moderate depression, severe depression scores are between 31-40 and 40 points above are interpreted as a very serious depression.
Measured: 2 minutes
Short Form McGill Pain Questionnaire
This questionnaire consists of 11 sensory and 4 affective descriptive words. These 15 words are described as 0 = absent, 1 = mild, 2 = moderate, 3 = severe pain. So three type of pain scores (sensory, affective, total = sensory + affective) are obtained. In McGill Pain Questionnaire, the current level of pain is measured by Visual Analog Scale (VAS) and Likert scale consisting of 6 points (0 = no pain, 1 = mild, 2 = irritating, 3 = bothersome, 4 = terrible, 5 = unbearable).
Measured: 1 minute
Pittsburgh Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
Measured: 2 minutes
Disease Activity Score- 28
Disease Activity Score (DAS) is an assessment tool used to measure the level of disease activity in patients with RA. The DAS combines information from swollen joints, tender joints, erythrocyte sedimentation rate (ESR), and patient self-report of general health
Measured: 10 minutes
The Rheumatoid Arthritis Quality of Life Questionnaire
The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a disease-specific quality of life measure that was developed simultaneously in the UK and the Netherlands. The content of the RAQoL was derived from in-depth qualitative interviews with RA patients exploring.
the impact of RA on their QoL.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start24 Dec 2018
- Primary completionJul 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songul Baglan Yentur, Gazi University
- Investigators
- Deran Oskay, Study director, Gazi University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836820
- Sponsor's protocol ID
- 436
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munsterman T, Takken T, Wittink H. Are persons with rheumatoid arthritis deconditioned? A review of physical activity and aerobic capacity. BMC Musculoskelet Disord. 2012 Oct 18;13:202. doi: 10.1186/1471-2474-13-202.
PubMed 23078261Rongen-van Dartel SA, Repping-Wuts H, Flendrie M, Bleijenberg G, Metsios GS, van den Hout WB, van den Ende CH, Neuberger G, Reid A, van Riel PL, Fransen J. Effect of Aerobic Exercise Training on Fatigue in Rheumatoid Arthritis: A Meta-Analysis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1054-62. doi: 10.1002/acr.22561.
PubMed 25624016Yentur SB, Atas N, Ozturk MA, Oskay D. Comparison of the effectiveness of pilates exercises, aerobic exercises, and pilates with aerobic exercises in patients with rheumatoid arthritis. Ir J Med Sci. 2021 Aug;190(3):1027-1034. doi: 10.1007/s11845-020-02412-2. Epub 2020 Oct 22.
PubMed 33094465
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03836820
- Acronym / sponsor ID
- 436
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arhritis, Pilates exercises, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 11 Feb 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.
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis. Articular and extraarticular sympthoms are mostly seen in patients with RA. Additionally, extra complaints such as depression, fatigue, kinesiophobia and physical inactivity may accompany. Positive effects of physical activity and exercise are known. In some studies, effects of pilates exercises have been investigated on many different diseases such as Multiple Sclerosis, Ankylosing Spondylitis and breast cancer. The aim of this study is to investigate effects of clinical pilates exercises on fatigue, depression, aerobic capacity, pain, quality of life, disease activity and sleep quality.
Detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis and is associated with progressive impairments and activity limitations. It may cause destruction of bone and cartilage by affecting synovial joints symmetrically. Organ involvement may be seen in the patients with RA as well as joint involvement. Initiation of the disease is mostly insidious and varies from patient to patient. Hand, wrist, foot, elbow and knee joints involvement are common. Furthermore almost all joints may be affected. Extraarticular symptoms are subcutaneous nodules, visceral nodules, cardiologic involvement, pulmonary involvement, eye involvement, neurological involvement, vasculitis, felty syndrome, amyloidosis, osteoporosis, liver and renal involvements. These symptoms may cause some extra complaints such as depression, fatigue, kinesiophobia and physical inactivity. Studies in literature have reported reduction in physical activity level in patients with RA. Reasons of physical inactivity can be listed as general obstacles such as lack of time, lack of motivation, weather condition and disease related blocks such as pain, fatigue, disease activity, depression, kinesiophobia. Depression prevalence in RA patients is found between 14.8% and 38.8% and this rate is estimated five times more than healthy people. Also, a study investigating pain in RA patients resulted that pain may be correlated with fatigue and depression. Fatigue which is frequently observed complaint of patients with rheumatic diseases is reported incidence between 40% and 80%. RA patients have been reported at high risk for cardiovascular diseases in EULAR recommendations.
Positive effects of physical activity and exercise on physiological, morphological and psychosocial conditions are known. Endurance, flexibility, muscle strength, body composition, self confidence and mood improve by regular exercise and high physical activity level. Furthermore, anti-inflammatory affects of exercise are proved in last years. Aims of pilates exercises which are developed by Joseph Pilates are to increase motor control, range of motion, flexibility, muscle strength and endurance, to improve balance, respiratory pattern and body awareness, to reduce stress. There are many studies investigating affects of pilates exercises on quality of life, functional capacity, posture, pain for different diseases including Multiple Sclerosis, Ankylosing Spondylitis, breast cancer. Aerobic and strengthening exercises reported to have positive affects on fatigue, quality of life, depression and pain for RA patients. The aim of this study is to investigate effects of clinical pilates exercises on fatigue, depression, aerobic capacity, pain, quality of life, disease activity and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical pilates exercise | Experimental | Other: Clinical pilates exercise, Other: Clinical Pilates and Aerobic ExerciseClinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. |
| Aerobic exercise | Experimental | Other: Aerobic exercise, Other: Clinical Pilates and Aerobic ExerciseProgressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks. |
| Clinical pilates and Aerobic exercise | Experimental | Other: Clinical pilates exercise, Other: Aerobic exercise, Other: Clinical Pilates and Aerobic ExerciseBoth clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18 to 65 and who have diagnosed with RA according to American College of Rheumatology criteria will be included the study.
Key exclusion criteria (1 listed)
- Patients who were pregnant, diagnosed with malignancy, had changes of medical treatment in the last 3 months, had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits, had regular exercise habit (minimally three days in a week), had high disease activity score (DAS-28>3.2) and had cardiac symphtoms according to New YorkHeart Association will be excluded from 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 |
|---|---|---|
| Clinical pilates exerciseClinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. | Other | Clinical pilates and Aerobic exercise, Clinical pilates exercise |
| Aerobic exerciseProgressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks. | Other | Aerobic exercise, Clinical pilates and Aerobic exercise |
| Clinical Pilates and Aerobic ExerciseBoth clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks. | Other | Aerobic exercise, Clinical pilates and Aerobic exercise, Clinical pilates exercise |
Primary outcome
Aerobic capacity
Time frame: 6 minutes
The 6-minute walk test is a submaximal exercise test used to quantify the functional exercise capacity in clinical populations. It measures the distance walked within a period of 6-minutes.
Fatigue severity scale
Time frame: 2 minutes
Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7
5 secondary outcomes
Beck Depression Inventory
Time frame: 2 minutes
Short Form McGill Pain Questionnaire
Time frame: 1 minute
Pittsburgh Sleep Quality
Time frame: 2 minutes
Disease Activity Score- 28
Time frame: 10 minutes
The Rheumatoid Arthritis Quality of Life Questionnaire
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Results publication: PubMed 23078261Munsterman T, Takken T, Wittink H. Are persons with rheumatoid arthritis deconditioned? A review of physical activity and aerobic capacity. BMC Musculoskelet Disord. 2012 Oct 18;13:202. doi: 10.1186/1471-2474-13-202.
- Results publication: PubMed 25624016Rongen-van Dartel SA, Repping-Wuts H, Flendrie M, Bleijenberg G, Metsios GS, van den Hout WB, van den Ende CH, Neuberger G, Reid A, van Riel PL, Fransen J. Effect of Aerobic Exercise Training on Fatigue in Rheumatoid Arthritis: A Meta-Analysis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1054-62. doi: 10.1002/acr.22561.
- Derived from this study: PubMed 33094465Yentur SB, Atas N, Ozturk MA, Oskay D. Comparison of the effectiveness of pilates exercises, aerobic exercises, and pilates with aerobic exercises in patients with rheumatoid arthritis. Ir J Med Sci. 2021 Aug;190(3):1027-1034. doi: 10.1007/s11845-020-02412-2. Epub 2020 Oct 22.
- 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.
Deran Oskay study director
Gazi University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pilates exercise, Aerobic exercise and Clinical Pilates and Aerobic Exercise in people with Rheumatoid Arthritis, run by Gazi 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Feb 2019. 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?
Contact Songul Baglan Yentur (+90 312 216 26 12, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (time frame: 6 minutes). The study lists 2 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 NCT03836820, which also lists 3 linked publications.
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 11 Feb 2019.