Psoriatic ArthritisNCT02995460
Interval Training Study in Psoriatic Arthritis
A study testing interval training in people with Psoriatic Arthritis, run by Norwegian University of Science and Technology.
Trial summary
Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced physical function. Patients have a higher risk of cardiovascular disease and a higher body mass index. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- 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
- fulfilling the CASPAR criteria of psoriatic arthritis
- ability to exercise.
Who cannot join
- Inability to exercise
- very high disease Activity
- unstable ischemic cardiovascular disease
- severe pulmonary disease
- pregnancy
- breastfeeding
- drug- and alcohol addictions
About this study
Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced physical function. Patients have a higher risk of cardiovascular disease and a higher body mass index.
A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation after 12 weeks of high-intensity interval training.
The primary aim of this study is to determine whether high-intensity interval training affects the disease activity in psoriatic arthritis. This intervention is believed to result in benefits in terms of inflammation, body composition and risk factors for cardiovascular disease.
- Conditions
- Psoriatic Arthritis
- Being tested
- interval training
- Keywords
- Exercise Therapy
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interval trainingBehavioural
4x4 high intensity interval training
| Study group | Role | What they receive |
|---|---|---|
| interval training | Experimental | 4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week. Receives: Behavioral: interval training |
| controls | No intervention | No change in diet and training habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient global assesment (PGA)
PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.
Measured: Baseline, 3 months (right after intervention), 9 months
Maximal oxygen uptake (VO2 max)
The VO2 max is measured as a change between timepoints
Measured: Baseline, 3 months (right after intervention), 9 months
Secondary outcomes (2)
Total lean mass
Total lean mass is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
Measured: Baseline, 3 months (right after intervention), 9 months
Total body fat
Total body fat is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
Measured: Baseline, 3 months (right after intervention), 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Siri Forsmo, md prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995460
- Sponsor's protocol ID
- 2012/1646
- Status last verified
- Nov 2018
- First submitted
- 14 Dec 2016
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Impact of High-Intensity Interval Training on Disease Activity and Disease in Patients With Psoriatic Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Apr;71(4):530-537. doi: 10.1002/acr.23614.
PubMed 29882634Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Effect of high-intensity interval training on cardiovascular disease risk factors and body composition in psoriatic arthritis: a randomised controlled trial. RMD Open. 2018 Oct 11;4(2):e000729. doi: 10.1136/rmdopen-2018-000729. eCollection 2018.
PubMed 30402265Thomsen RS, Nilsen TIL, Haugeberg G, Sitter B, Kavanaugh A, Pedersen SJ, Hoff M. Changes of inflammation in patients with psoriatic arthritis after high intensity interval training assessed by ultrasound and MRI, a randomized controlled trial. BMC Musculoskelet Disord. 2023 Sep 19;24(1):743. doi: 10.1186/s12891-023-06871-3.
PubMed 37726677Chronaiou I, Thomsen RS, Huuse EM, Euceda LR, Pedersen SJ, Hoff M, Sitter B. Quantifying bone marrow inflammatory edema in the spine and sacroiliac joints with thresholding. BMC Musculoskelet Disord. 2017 Nov 28;18(1):497. doi: 10.1186/s12891-017-1861-1.
PubMed 29179748
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval Training Study in Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT02995460
- Acronym / sponsor ID
- 2012/1646
- Conditions
- Psoriatic Arthritis
- Keywords
- Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Midt-Norge
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2016 (estimated)
- 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.
Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced physical function. Patients have a higher risk of cardiovascular disease and a higher body mass index.
A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation after 12 weeks of high-intensity interval training.
The primary aim of this study is to determine whether high-intensity interval training affects the disease activity in psoriatic arthritis. This intervention is believed to result in benefits in terms of inflammation, body composition and risk factors for cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interval training | Experimental | Behavioral: interval training4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week. |
| controls | No intervention | –No change in diet and training habits |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fulfilling the CASPAR criteria of psoriatic arthritis
- ability to exercise.
Key exclusion criteria (7 listed)
- Inability to exercise
- very high disease Activity
- unstable ischemic cardiovascular disease
- severe pulmonary disease
- pregnancy
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 |
|---|---|---|
| interval training4x4 high intensity interval training | Behavioural | interval training |
Primary outcome
Patient global assesment (PGA)
Time frame: Baseline, 3 months (right after intervention), 9 months
PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.
Maximal oxygen uptake (VO2 max)
Time frame: Baseline, 3 months (right after intervention), 9 months
The VO2 max is measured as a change between timepoints
2 secondary outcomes
Total lean mass
Time frame: Baseline, 3 months (right after intervention), 9 months
Total body fat
Time frame: Baseline, 3 months (right after intervention), 9 months
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 13 Nov 2018.
- Results publication: PubMed 29882634Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Impact of High-Intensity Interval Training on Disease Activity and Disease in Patients With Psoriatic Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Apr;71(4):530-537. doi: 10.1002/acr.23614.
- Results publication: PubMed 30402265Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Effect of high-intensity interval training on cardiovascular disease risk factors and body composition in psoriatic arthritis: a randomised controlled trial. RMD Open. 2018 Oct 11;4(2):e000729. doi: 10.1136/rmdopen-2018-000729. eCollection 2018.
- Derived from this study: PubMed 37726677Thomsen RS, Nilsen TIL, Haugeberg G, Sitter B, Kavanaugh A, Pedersen SJ, Hoff M. Changes of inflammation in patients with psoriatic arthritis after high intensity interval training assessed by ultrasound and MRI, a randomized controlled trial. BMC Musculoskelet Disord. 2023 Sep 19;24(1):743. doi: 10.1186/s12891-023-06871-3.
- Derived from this study: PubMed 29179748Chronaiou I, Thomsen RS, Huuse EM, Euceda LR, Pedersen SJ, Hoff M, Sitter B. Quantifying bone marrow inflammatory edema in the spine and sacroiliac joints with thresholding. BMC Musculoskelet Disord. 2017 Nov 28;18(1):497. doi: 10.1186/s12891-017-1861-1.
- 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.
Siri Forsmo, md prof study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing interval training in people with Psoriatic Arthritis, run by Norwegian University of Science and Technology.
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 2 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient global assesment (PGA) (time frame: Baseline, 3 months (right after intervention), 9 months). 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 NCT02995460, which also lists 4 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 13 Nov 2018.