Psoriatic ArthritisNCT06176586
Mat Pilates Exercise Program in Patients With Axial Psoriatic Arthritis
A study testing Mat Pilates Exercises in people with Psoriatic Arthritis, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of mat Pilates exercises on spinal mobility, spinal muscle endurance, disease activity, fatigue, emotional well-being, physical performance, and overall quality of life in Psoriatic Arthritis (PsA) patients with axial involvement. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Mat Pilates Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2024to 10 Jun 2024
- 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
- Being classified as PsA according to CASPAR Classification Criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Who cannot join
- Any additional systemic disease other than PsA
- Any other condition that may prevent participation/continuation of the exercise program or completion of the assessments
- Regular exercise habits (following a structured exercise program at least 3 days a week)
- Being included in a physiotherapy and rehabilitation program within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Mat Pilates Exercises in Patients With Axial Psoriatic Arthritis
The aim of this study is to investigate the effectiveness of mat Pilates exercises on spinal mobility, spinal muscle endurance, disease activity, fatigue, emotional well-being, physical performance, and overall quality of life in Psoriatic Arthritis (PsA) patients with axial involvement.
Read the detailed description
Psoriasis is a chronic inflammatory skin disease commonly accompanied by joint involvement known as psoriatic arthritis (PsA) [1]. PsA is a subgroup of spondyloarthritis and is characterized by peripheral arthritis, dactylitis, enthesitis and spondylitis. Axial involvement, which occurs in approximately 40% of PsA patients may affect the entire spine, particularly the sacroiliac joint, leading to reduced cervical rotation, lateral flexion and anterior flexion of the spine [2,3]. Exercise interventions in PsA primarily aim to relieve pain, improve mobility and enhance functional capacity [4]. Mat Pilates exercises have been demonstrated as a safe and beneficial intervention in various rheumatic diseases, exhibiting significant improvements in functional status, fatigue, disease activity, pain, and overall quality of life [5-7]. Additionally, Pilates has been reported as effective in maintaining and enhancing spinal mobility [8,9]. However, despite these favorable outcomes, the efficacy of Pilates exercises in PsA remains unexplored.
The aim of this study is to investigate the effectiveness of mat pilates exercises in psoriatic arthritis patients with axial involvement.
- Conditions
- Psoriatic Arthritis
- Being tested
- Mat Pilates Exercises
- Keywords
- Pilates Exercise, Arthritis, Spine Mobility
- Medical subject headings
- Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mat Pilates ExercisesOther
The intervention will consist of mat Pilates exercises performed twice a week over a duration of 12 weeks, as an adjunct to the routine medical treatment for the patients, under the guidance of a qualified physiotherapist. Each exercise session will last for approximately 60 minutes. The treatment protocol will encompass targeted mobility exercises for the thoracic and lumbar regions, along with strengthening exercises focusing on core activation. The exercise program will be progressed in every four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Progressive mat Pilates exercises will be administered to by a physiotherapist in addition to the routine medical treatment. Receives: Other: Mat Pilates Exercises |
| Control Group | No intervention | Patients in control group will not receive any exercise intervention. They will continue to their routine medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Performance
The Ankylosing Spondylitis Performance Index (ASPI) will be used. The ASPI consists of three physical performance tasks: (a) bending forward to pick up six pencils from the floor; (b) putting on socks (average of three repetitions); and (c) getting up from the floor (average of three repetitions). Time to complete a task will be recorded in seconds for each test.
Measured: At baseline and 12 weeks later
Secondary outcomes (7)
Change in Functional Status
Bath Ankylosing Spondylitis Functional Index (BASFI) will be used. This self-reported scale evaluates the degree of functional limitation of patients in activities of daily living. It consists of 10 questions scored between 0-10 (0: easy, 10: impossible). The higher total scores indicate more functional limitation.
Measured: At baseline and 12 weeks later
Change in Trunk Muscle Endurance
A static endurance test (lateral bridge test) will be employed to evaluate trunk muscle endurance. During this assessment, patients will be positioned in side-lying. Participants will be required to maintain this lateral bridge position for as long as possible, and the duration until the position cannot be maintained will be recorded in seconds.
Measured: At baseline and 12 weeks later
Change in Spinal Mobility
Spinal mobility will be assessed by using the Bath Ankylosing Spondylitis Mobility Index including cervical rotation, modified Schober test (anterior flexion of the spine), maximal intermalleolar distance, lateral flexion of the spine, and tragus-wall distance. Higher scores indicate more limited spinal mobility.
Measured: At baseline and 12 weeks later
Chance in Disease Activity
The Disease Activity Index for Psoriatic Arthritis (DAPSA) will be used for evaluating the disease activity. DAPSA is a composite score including the number of tender joints (over 68 joints), the number of swollen joints (over 68 joints), C-Reactive protein (CRP) level, the patient's self-reported health status, and evaluation of the patient's health status by the physician. DAPSA is calculated by summing all the values, and higher scores indicate higher disease activity.
Measured: At baseline and 12 weeks later
Change in Fatigue
The Fatigue Severity Scale (FSS) will be used to evaluate the fatigue. It comprises 9 items that assess the severity of fatigue symptoms experienced by participants over the previous week. Each question is scored on a scale ranging from 1 (strongly disagree) to 7 (strongly agree), and the scores are then averaged to derive the total score. Higher scores indicate more fatigue.
Measured: At baseline and 12 weeks later
Change in Emotional Status
The Hospital Anxiety and Depression Scale (HADS) will be used to evaluate emotional status. The HADS includes two sections: depression (7 questions) and anxiety (7 questions). Each question is scored between 0 and 3. Higher scores indicate higher anxiety or depression levels.
Measured: At baseline and 12 weeks later
Change in Quality of Life
The Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire will be used to assess the disease-related changes in quality of life. The PsAQoL includes 20 questions, each answered with either yes (1 point) or no (0 point). Higher scores indicate a reduced quality of life.
Measured: At baseline and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start8 Jan 2024
- Primary completion11 Mar 2024
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies 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
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Bayraktar, Izmir Katip Celebi University
- Investigators
- Deniz Bayraktar, PhD, Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176586
- Sponsor's protocol ID
- PSApilex
- Status last verified
- Apr 2024
- First submitted
- 7 Dec 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may only be provided upon a reasonable request for academic research purposes.
Publications
Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
PubMed 23014338Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015 Nov;41(4):545-68. doi: 10.1016/j.rdc.2015.07.001. Epub 2015 Sep 11.
PubMed 26476218Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
PubMed 15708927Chimenti MS, Triggianese P, Conigliaro P, Santoro M, Lucchetti R, Perricone R. Self-reported adherence to a home-based exercise program among patients affected by psoriatic arthritis with minimal disease activity. Drug Dev Res. 2014 Nov;75 Suppl 1:S57-9. doi: 10.1002/ddr.21197.
PubMed 25381979Altan L, Korkmaz N, Dizdar M, Yurtkuran M. Effect of Pilates training on people with ankylosing spondylitis. Rheumatol Int. 2012 Jul;32(7):2093-9. doi: 10.1007/s00296-011-1932-9. Epub 2011 Apr 17.
PubMed 21499876Caglayan BC, Keskin A, Gur Kabul E, Basakci Calik B, Bas Aslan U, Karasu U. Effects of clinical Pilates exercises in individuals with fibromyalgia: A randomized controlled trial. Eur J Rheumatol. 2021 Jul;8(3):150-155. doi: 10.5152/eurjrheum.2020.20037.
PubMed 33372888Acar Y, Ilcin N, Gurpinar B, Can G. The effects of clinical pilates training on disease-specific indices, core stability, and balance in patients with ankylosing spondylitis. J Bodyw Mov Ther. 2023 Jan;33:69-75. doi: 10.1016/j.jbmt.2022.09.010. Epub 2022 Sep 23.
PubMed 36775528Oksuz S, Unal E. Comparison of the effects of aerobic training alone versus aerobic training combined with clinical Pilates exercises on the functional and psychosocial status of patients with ankylosing spondylitis: A randomized controlled trial. Physiother Theory Pract. 2023 Jan;39(1):61-71. doi: 10.1080/09593985.2021.2005199. Epub 2021 Nov 18.
PubMed 34791973
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Mat Pilates Exercises in Patients With Axial Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT06176586
- Acronym / sponsor ID
- PSApilex
- Conditions
- Psoriatic Arthritis
- Keywords
- Pilates Exercise, Arthritis, Spine Mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 19 Dec 2023 (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 this study is to investigate the effectiveness of mat Pilates exercises on spinal mobility, spinal muscle endurance, disease activity, fatigue, emotional well-being, physical performance, and overall quality of life in Psoriatic Arthritis (PsA) patients with axial involvement.
Detailed description
Psoriasis is a chronic inflammatory skin disease commonly accompanied by joint involvement known as psoriatic arthritis (PsA) [1]. PsA is a subgroup of spondyloarthritis and is characterized by peripheral arthritis, dactylitis, enthesitis and spondylitis. Axial involvement, which occurs in approximately 40% of PsA patients may affect the entire spine, particularly the sacroiliac joint, leading to reduced cervical rotation, lateral flexion and anterior flexion of the spine [2,3]. Exercise interventions in PsA primarily aim to relieve pain, improve mobility and enhance functional capacity [4]. Mat Pilates exercises have been demonstrated as a safe and beneficial intervention in various rheumatic diseases, exhibiting significant improvements in functional status, fatigue, disease activity, pain, and overall quality of life [5-7]. Additionally, Pilates has been reported as effective in maintaining and enhancing spinal mobility [8,9]. However, despite these favorable outcomes, the efficacy of Pilates exercises in PsA remains unexplored.
The aim of this study is to investigate the effectiveness of mat pilates exercises in psoriatic arthritis patients with axial involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Mat Pilates ExercisesProgressive mat Pilates exercises will be administered to by a physiotherapist in addition to the routine medical treatment. |
| Control Group | No intervention | –Patients in control group will not receive any exercise intervention. They will continue to their routine medical treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being classified as PsA according to CASPAR Classification Criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Any additional systemic disease other than PsA
- Any other condition that may prevent participation/continuation of the exercise program or completion of the assessments
- Regular exercise habits (following a structured exercise program at least 3 days a week)
- Being included in a physiotherapy and rehabilitation program within the last 6 months
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 |
|---|---|---|
| Mat Pilates ExercisesThe intervention will consist of mat Pilates exercises performed twice a week over a duration of 12 weeks, as an adjunct to the routine medical treatment for the patients, under the guidance of a qualified physiotherapist. Each exercise session will last for approximately 60 minutes. The treatment protocol will encompass targeted mobility exercises for the thoracic and lumbar regions, along with strengthening exercises focusing on core activation. The exercise program will be progressed in every four weeks. | Other | Exercise Group |
Primary outcome
Change in Physical Performance
Time frame: At baseline and 12 weeks later
The Ankylosing Spondylitis Performance Index (ASPI) will be used. The ASPI consists of three physical performance tasks: (a) bending forward to pick up six pencils from the floor; (b) putting on socks (average of three repetitions); and (c) getting up from the floor (average of three repetitions). Time to complete a task will be recorded in seconds for each test.
7 secondary outcomes
Change in Functional Status
Time frame: At baseline and 12 weeks later
Change in Trunk Muscle Endurance
Time frame: At baseline and 12 weeks later
Change in Spinal Mobility
Time frame: At baseline and 12 weeks later
Chance in Disease Activity
Time frame: At baseline and 12 weeks later
Change in Fatigue
Time frame: At baseline and 12 weeks later
Change in Emotional Status
Time frame: At baseline and 12 weeks later
Change in Quality of Life
Time frame: At baseline and 12 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 23014338Parisi R, Symmons DP, Griffiths CE, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013 Feb;133(2):377-85. doi: 10.1038/jid.2012.339. Epub 2012 Sep 27.
- Background: PubMed 26476218Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015 Nov;41(4):545-68. doi: 10.1016/j.rdc.2015.07.001. Epub 2015 Sep 11.
- Background: PubMed 15708927Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
- Background: PubMed 25381979Chimenti MS, Triggianese P, Conigliaro P, Santoro M, Lucchetti R, Perricone R. Self-reported adherence to a home-based exercise program among patients affected by psoriatic arthritis with minimal disease activity. Drug Dev Res. 2014 Nov;75 Suppl 1:S57-9. doi: 10.1002/ddr.21197.
- Background: PubMed 21499876Altan L, Korkmaz N, Dizdar M, Yurtkuran M. Effect of Pilates training on people with ankylosing spondylitis. Rheumatol Int. 2012 Jul;32(7):2093-9. doi: 10.1007/s00296-011-1932-9. Epub 2011 Apr 17.
- Background: PubMed 33372888Caglayan BC, Keskin A, Gur Kabul E, Basakci Calik B, Bas Aslan U, Karasu U. Effects of clinical Pilates exercises in individuals with fibromyalgia: A randomized controlled trial. Eur J Rheumatol. 2021 Jul;8(3):150-155. doi: 10.5152/eurjrheum.2020.20037.
- Background: PubMed 36775528Acar Y, Ilcin N, Gurpinar B, Can G. The effects of clinical pilates training on disease-specific indices, core stability, and balance in patients with ankylosing spondylitis. J Bodyw Mov Ther. 2023 Jan;33:69-75. doi: 10.1016/j.jbmt.2022.09.010. Epub 2022 Sep 23.
- Background: PubMed 34791973Oksuz S, Unal E. Comparison of the effects of aerobic training alone versus aerobic training combined with clinical Pilates exercises on the functional and psychosocial status of patients with ankylosing spondylitis: A randomized controlled trial. Physiother Theory Pract. 2023 Jan;39(1):61-71. doi: 10.1080/09593985.2021.2005199. Epub 2021 Nov 18.
- Individual participant dataSharing planned: No. Data may only be provided upon a reasonable request for academic research purposes.
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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.
Deniz Bayraktar, PhD principal investigator
Izmir Katip Celebi 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 Mat Pilates Exercises in people with Psoriatic Arthritis, 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 3 inclusion and 4 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 10 Apr 2024. 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?
Change in Physical Performance (time frame: At baseline and 12 weeks later). 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 NCT06176586, which also lists 8 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 10 Apr 2024.