Rheumatoid ArthritisRA-HIITNCT05768165
High-intensity Interval Exercise in Rheumatoid Arthritis
A study testing High intensity exercise in people with Rheumatoid Arthritis, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial summary
Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- High intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesSweden
- Study dates
- 16 Aug 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria
- Disease duration >1 year
- Age (range 20-60 years)
- Stable medication on anti- rheumatic drugs for >3 months
- Low-to-moderate disease activity (<5.1) according to the Disease activity score 28 (DAS28)
Who cannot join
- Cerebrovascular diseases
- Diabetes
- Severe hypertension
- Chronic obstructive pulmonary disease or other severe pulmonary diseases
- Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise
- Arthroplasty of large joints
Show all 10Show fewer
- Inability to manage Cardiopulmonary Exercise Testing (CPET)
- Pregnancy
- Already participating in regular aerobic or strength exercise at a high intensity level (>1 hours/ week) during the last 6 months
- Inability to speak or read Swedish.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska university hospital
Gothenburg, 413 45
Uddevalla Hospital
Uddevalla
About this study
Official title: Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis
Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.
- Conditions
- Rheumatoid Arthritis
- Being tested
- High intensity exercise
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseBehavioural
Also called Person- centeredness
Twelve weeks of supervised high intensity aerobic and resistance exercise including two sessions/week, one additional session of the patient´s own choice, non-supervised. The target of the high intensity intervals (HIIT) is 90%-95% of maximum heart rate alternated with recovery phases at 70% of maximal heart rate. The resistance exercise session of large muscle groups: 8-10 repetitions, 2-3 sets.
Exercise guidance follows principles of self-efficacy and person-centeredness.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Cardiorespiratory and strength exercise training 2-3 sessions per week Receives: Behavioral: High intensity exercise |
| Care as usual | No intervention | Care as usual and information of health enhancing physical activity according to general recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary function
Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)
Measured: 0 -12 weeks
Secondary outcomes (42)
Vascular function
Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function)
Measured: 0-12 weeks
Level of disease activity
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Measured: 0-12 weeks
Level of disease activity
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Measured: 0-6 months
Level of disease activity
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Measured: 0-12 months
Homeostatic model assessment of insulin resistance (HOMA IR)
Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR
Measured: 0-12 weeks
Glycosylation level of hemoglobin (HbA1c)
Glycosylation level of hemoglobin (mmol/mol)
Measured: 0-12 weeks
Level of blood lipids
Levels of triglycerides (mmol/L), Level of high-density lipoprotein (HDL) (mmol/L), low-density lipoprotein (LDL) ( mmol/L), Total cholesterol (mmol/L )
Measured: 0-12 weeks
Erythrocyte Sedimentation Rate (ESR)
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Measured: 0-12 weeks
Erythrocyte Sedimentation Rate (ESR)
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Measured: 0-6 months
Erythrocyte Sedimentation Rate (ESR)
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Measured: 0-12 months
C-Reactive Protein (CRP)
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Measured: 0-12 weeks
C-Reactive Protein (CRP)
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Measured: 0-6 months
C-Reactive Protein (CRP)
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Measured: 0-12 months
Cytokine levels
Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL)
Measured: 0-12 weeks
Muscle function of lower extremities
The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities)
Measured: 0-12 weeks
Hand-grip force
Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength)
Measured: 0-12 weeks
Self-reported physical activity
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Measured: 0-12 weeks
Self-reported physical activity
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Measured: 0-6 months
Self-reported physical activity
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Measured: 0-12 months
Objective assessment of physical activity
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Measured: 0-12 weeks
Objective assessment of physical activity
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Measured: 0-6 months
Objective assessment of physical activity
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Measured: 0-12 months
Pain intensity
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Measured: 0-12 weeks
Pain intensity
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Measured: 0-6 months
Pain intensity
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Measured: 0-12 months
Global health
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Measured: 0-12 weeks
Global health
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Measured: 0-6 months
Global health
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Measured: 0-12 months
Fatigue
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Measured: 0-12 weeks
Fatigue
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Measured: 0-6 months
Fatigue
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Measured: 0-12 months
Sleep
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Measured: 0-12 weeks
Sleep
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Measured: 0-6 months
Sleep
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Measured: 0-12 months
Activity limitations
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Measured: 0-12 weeks
Activity limitations
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Measured: 0-6 months
Activity limitations
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Measured: 0-12 months
Attitude to exercise
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Measured: 0-12 weeks
Attitude to exercise
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Measured: 0-6 moths
Attitude to exercise
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Measured: 0-12 months
Body compositions
Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight)
Measured: 0-12 weeks
Waist circumference
Measured with a tape measure midway between the lower rib and iliac crest. (A waist measurement of 80 centimeters or more for women and 94 centimeters or more for men indicate increased risk for diseases related to overweight)
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start16 Aug 2021
- Primary completion30 Jun 2023
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid 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
- Model description
- Intervention versus care as usual
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Annelie Bilberg, PhD, Study director, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768165
- Sponsor's protocol ID
- Vastra Gotaland record 275642
- Acronym
- RA-HIIT
- Status last verified
- Dec 2025
- First submitted
- 6 Sep 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in a publication are available from the principal investigator (P.I.) on reasonable request. Access will be determined based on reasonable request and in accordance with the ethical approval
Publications
Bilberg A, Bjersing J, Borjesson M, Sivertsson J, Mannerkorpi K. High-intensity exercise improves multidimensional fatigue and health-related quality of life in rheumatoid arthritis: a randomized controlled study. Arthritis Res Ther. 2025 Sep 18;27(1):176. doi: 10.1186/s13075-025-03643-3.
PubMed 40968365Bilberg A, Mannerkorpi K, Borjesson M, Svedlund S, Sivertsson J, Klingberg E, Bjersing J. High-intensity interval training improves cardiovascular and physical health in patients with rheumatoid arthritis: a multicentre randomised controlled trial. Br J Sports Med. 2024 Dec 2;58(23):1409-1418. doi: 10.1136/bjsports-2024-108369.
PubMed 39179363
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05768165
- Acronym / sponsor ID
- RA-HIIT / Vastra Gotaland record 275642
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Mar 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.
Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention versus care as usual
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: High intensity exerciseCardiorespiratory and strength exercise training 2-3 sessions per week |
| Care as usual | No intervention | –Care as usual and information of health enhancing physical activity according to general recommendations |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria
- Disease duration >1 year
- Age (range 20-60 years)
- Stable medication on anti- rheumatic drugs for >3 months
- Low-to-moderate disease activity (<5.1) according to the Disease activity score 28 (DAS28)
Key exclusion criteria (10 listed)
- Cerebrovascular diseases
- Diabetes
- Severe hypertension
- Chronic obstructive pulmonary disease or other severe pulmonary diseases
- Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise
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 |
|---|---|---|
| High intensity exerciseAlso: Person- centerednessTwelve weeks of supervised high intensity aerobic and resistance exercise including two sessions/week, one additional session of the patient´s own choice, non-supervised. The target of the high intensity intervals (HIIT) is 90%-95% of maximum heart rate alternated with recovery phases at 70% of maximal heart rate. The resistance exercise session of large muscle groups: 8-10 repetitions, 2-3 sets. Exercise guidance follows principles of self-efficacy and person-centeredness. | Behavioural | Intervention group |
Primary outcome
Cardiopulmonary function
Time frame: 0 -12 weeks
Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)
42 secondary outcomes
Vascular function
Time frame: 0-12 weeks
Level of disease activity
Time frame: 0-12 weeks
Level of disease activity
Time frame: 0-6 months
Level of disease activity
Time frame: 0-12 months
Homeostatic model assessment of insulin resistance (HOMA IR)
Time frame: 0-12 weeks
Glycosylation level of hemoglobin (HbA1c)
Time frame: 0-12 weeks
Level of blood lipids
Time frame: 0-12 weeks
Erythrocyte Sedimentation Rate (ESR)
Time frame: 0-12 weeks
Erythrocyte Sedimentation Rate (ESR)
Time frame: 0-6 months
Erythrocyte Sedimentation Rate (ESR)
Time frame: 0-12 months
C-Reactive Protein (CRP)
Time frame: 0-12 weeks
C-Reactive Protein (CRP)
Time frame: 0-6 months
C-Reactive Protein (CRP)
Time frame: 0-12 months
Cytokine levels
Time frame: 0-12 weeks
Muscle function of lower extremities
Time frame: 0-12 weeks
Hand-grip force
Time frame: 0-12 weeks
Self-reported physical activity
Time frame: 0-12 weeks
Self-reported physical activity
Time frame: 0-6 months
Self-reported physical activity
Time frame: 0-12 months
Objective assessment of physical activity
Time frame: 0-12 weeks
Objective assessment of physical activity
Time frame: 0-6 months
Objective assessment of physical activity
Time frame: 0-12 months
Pain intensity
Time frame: 0-12 weeks
Pain intensity
Time frame: 0-6 months
Pain intensity
Time frame: 0-12 months
Global health
Time frame: 0-12 weeks
Global health
Time frame: 0-6 months
Global health
Time frame: 0-12 months
Fatigue
Time frame: 0-12 weeks
Fatigue
Time frame: 0-6 months
Fatigue
Time frame: 0-12 months
Sleep
Time frame: 0-12 weeks
Sleep
Time frame: 0-6 months
Sleep
Time frame: 0-12 months
Activity limitations
Time frame: 0-12 weeks
Activity limitations
Time frame: 0-6 months
Activity limitations
Time frame: 0-12 months
Attitude to exercise
Time frame: 0-12 weeks
Attitude to exercise
Time frame: 0-6 moths
Attitude to exercise
Time frame: 0-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 40968365Bilberg A, Bjersing J, Borjesson M, Sivertsson J, Mannerkorpi K. High-intensity exercise improves multidimensional fatigue and health-related quality of life in rheumatoid arthritis: a randomized controlled study. Arthritis Res Ther. 2025 Sep 18;27(1):176. doi: 10.1186/s13075-025-03643-3.
- Derived from this study: PubMed 39179363Bilberg A, Mannerkorpi K, Borjesson M, Svedlund S, Sivertsson J, Klingberg E, Bjersing J. High-intensity interval training improves cardiovascular and physical health in patients with rheumatoid arthritis: a multicentre randomised controlled trial. Br J Sports Med. 2024 Dec 2;58(23):1409-1418. doi: 10.1136/bjsports-2024-108369.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in a publication are available from the principal investigator (P.I.) on reasonable request. Access will be determined based on reasonable request and in accordance with the ethical approval
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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.
Annelie Bilberg, PhD study director
Vastra Gotaland Region
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exercise in people with Rheumatoid Arthritis, run by Vastra Gotaland Region at 2 sites in Sweden.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cardiopulmonary function (time frame: 0 -12 weeks). 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 NCT05768165, which also lists 2 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 22 Dec 2025.