Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis (PsA-HIIT)

January 19, 2026 updated by: Vastra Gotaland Region

Effects of Combined High-Intensity Aerobic Training and Resistance Training on Cardiovascular and Metabolic Health in Psoriatic Arthritis

The goal of this randomised controlled trial is to evaluate the effects of a 12-week intervention comprising high-intensity interval aerobic training and strength training on cardiovascular function, metabolic health profile and inflammation in patients with Psoriatic arthritis. A secondary goal is to assess the intervention´s impact on physical fitness, pain, fatigue, and health-related quality of life, and to explore long-term maintenance of exercise following completion of the intervention. We hypothesize that 12 weeks of combined high-intensity interval aerobic training and strength training will improve cardiometabolic health, inflammation, and enhance physical fitness, fatigue, pain and quality of life in Psoriatic arthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Annelie Bilberg, Associate professor
      • Skövde, Sweden

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Psoriatic arthritis disease according to the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria
  • Age range 18-65 years
  • Stable medication on anti- rheumatic drugs for >3 months prior to inclusion and throughout the first 3 months of the study

Exclusion Criteria:

  • Cardiovascular disease
  • Severe hypertension
  • Diabetes type I
  • Chronic obstructive pulmonary disease or other severe pulmonary diseases
  • Arthroplasty of large joints, lower extremities
  • Severe functional impairment precluding participation in high-intensity aerobic exercise
  • Inability to perform a cardiopulmonary exercise testing (CPET)
  • Pregnancy
  • BMI ≥35 kg/m²
  • Ongoing or planned initiation (within 3 months) of structured weight reduction therapy, pharmacological obesity treatment, or bariatric bypass surgery
  • Already participating in regular exercise at high intensity (BORG ≥15) for >1 hour/ week during the past 6 months
  • Inability to understand and read Swedish

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise group
Cardiorespiratory and strength training, 2-3 sessions per week for a total of 12 weeks.
Behavioral: Exercise program
The exercise program includes two supervised sessions per week combining high-intensity interval training and strength training, plus one additional non-supervised aerobic session. The target of the high intensity intervals is 90%-95% of heart rate maximum. The strength training of major muscle groups includes 2-3 sets of 8-10 repetitions.
No Intervention: Control group
Care as usual, plus individualized counseling for health-promoting physical activity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiopulmonary function
Time Frame: Baseline and 3 month
Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity.
Baseline and 3 month
Cardiopulmonary function
Time Frame: Baseline and 9 month
Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity)
Baseline and 9 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: Baseline and 3 months
Change in waist circumference (cm) 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.
Baseline and 3 months
Waist circumference
Time Frame: Baseline and 9 months
Change in waist circumference (cm) 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.
Baseline and 9 months
Body mass index (BMI)
Time Frame: Baseline and 3 months
Change in Body Mass Index (BMI). Weight and height will be combined to report BMI (kg/m2). A higher score indicate higher relative weight.
Baseline and 3 months
Body mass index (BMI)
Time Frame: Baseline and 9 months
Change in Body Mass Index (BMI). Weight and height will be combined to report BMI (kg/m2). A higher score indicate higher relative weight.
Baseline and 9 months
Body composition
Time Frame: Baseline and 3 months
Change in total leanmass (%) and fatmass (%) assessed with Bioelectrical Impedance Analysis. Higher value indicate higher total leanmass and fatmass
Baseline and 3 months
Body composition
Time Frame: Baseline and 9 months
Change in total leanmass (%) and fatmass (%) assessed with Bioelectrical Impedance Analysis. Higher value indicate higher total leanmass and fatmass
Baseline and 9 months
Triglycerides
Time Frame: Baseline and 3 months
Change in triglycerides (mmol/L)
Baseline and 3 months
Triglycerides
Time Frame: Baseline and 9 months
Change in triglycerides (mmol/L)
Baseline and 9 months
High-density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline and 3 months
Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)
Baseline and 3 months
High-density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline and 9 months
Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)
Baseline and 9 months
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline and 3 months
Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Baseline and 3 months
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline and 9 months
Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Baseline and 9 months
Total cholesterol
Time Frame: Baseline and 3 months
Change in total cholesterol (mmol/L)
Baseline and 3 months
Total cholesterol
Time Frame: Baseline and 9 months
Change in total cholesterol (mmol/L)
Baseline and 9 months
Glycosylation level of hemoglobin (HbA1c)
Time Frame: Baseline and 3 months
Glycosylation level of hemoglobin (HbA1c) (mmol/mol)
Baseline and 3 months
Glycosylation level of hemoglobin (HbA1c)
Time Frame: Baseline and 9 months
Glycosylation level of hemoglobin (HbA1c) (mmol/mol)
Baseline and 9 months
Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline and 3 months
Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.
Baseline and 3 months
Erythrocyte Sedimentation Rate (ESR)
Time Frame: Baseline and 9 months
Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.
Baseline and 9 months
C-Reactive Protein (CRP)
Time Frame: Baseline and 3 months
Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.
Baseline and 3 months
C-Reactive Protein (CRP)
Time Frame: Baseline and 9 months
Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.
Baseline and 9 months
Cytokine levels
Time Frame: Baseline and 3 months
Change in inflammatory cytokines such as Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL).
Baseline and 3 months
Muscle function lower extremities
Time Frame: Baseline and 3 months
Change in the one minute sit-to-stand test (STS). Higher numbers of complete rises indicate better muscle function in lower extremities.
Baseline and 3 months
Muscle function lower extremities
Time Frame: Baseline and 9 months
Change in the one minute sit-to-stand test (STS). Higher numbers of complete rises indicate better muscle function in lower extremities.
Baseline and 9 months
Handgrip strength
Time Frame: Baseline and 3 months
Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.
Baseline and 3 months
Handgrip strength
Time Frame: Baseline and 9 months
Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.
Baseline and 9 months
Physical function
Time Frame: Baseline and 3 months
Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations
Baseline and 3 months
Physical function
Time Frame: Baseline and 9 months
Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations
Baseline and 9 months
Attitude to exercise
Time Frame: Baseline and 3 months
Change in exercise believe assessed with the Exercise Health Beliefs questionnaire (20-100), Higher score represents stronger exercise beliefs.
Baseline and 3 months
Attitude to exercise
Time Frame: Baseline and 9 months
Change in exercise believe assessed with the Exercise Health Beliefs questionnaire (20-100), Higher score represents stronger exercise beliefs.
Baseline and 9 months
Emotional experience of exercise
Time Frame: Baseline and 3 months
Change in the Physical Activity Enjoyment Scale (PACES) (18-126). Higher score indicate higher degreee of enjoyment and pleasure related to exercising.
Baseline and 3 months
Emotional experience of exercise
Time Frame: Baseline and 9 months
Change in the Physical Activity Enjoyment Scale (PACES) (18-126). Higher score indicate higher degreee of enjoyment and pleasure related to exercising.
Baseline and 9 months
Sleep quality
Time Frame: Baseline and 3 months
Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.
Baseline and 3 months
Sleep quality
Time Frame: Baseline and 9 months
Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.
Baseline and 9 months
Fatigue
Time Frame: Baseline and 3 months
Change in The Multiple Fatigue Inventory (MFI-20), 4-20 for each subscale, Higher score indicates a higher degree of fatigue.
Baseline and 3 months
Fatigue
Time Frame: Baseline and 9 months
Change in The Multiple Fatigue Inventory (MFI-20), 4-20 for each subscale, Higher score indicates a higher degree of fatigue
Baseline and 9 months
Pain intensity
Time Frame: Baseline and 3 months
Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.
Baseline and 3 months
Pain intensity
Time Frame: Baseline and 9 months
Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.
Baseline and 9 months
Global health
Time Frame: Baseline and 3 months
Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health
Baseline and 3 months
Global health
Time Frame: Baseline and 9 months
Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health
Baseline and 9 months
Health related quality of life
Time Frame: Baseline and 3 months
Change in the 36-item Short Form Health Survey (SF-36) questionnare (0-100). A higher score indicate better health related quality of life
Baseline and 3 months
Health related quality of life
Time Frame: Baseline and 9 months
Change in the 36-item Short Form Health Survey (SF-36) questionnare (0-100). A higher score indicate better health related quality of life
Baseline and 9 months
The impact of the disease on quality of life
Time Frame: Baseline and 3 months
Change in the Dermatology Life Quality Index (DLQI) (0-30). Higher score indicate worse impairment
Baseline and 3 months
The impact of the disease on quality of life
Time Frame: Baseline and 9 months
Change in the Dermatology Life Quality Index (DLQI) (0-30). Higher score indicate worse impairment
Baseline and 9 months
Mental health
Time Frame: Baseline and 3 months
Change in the Hospital and Anxiety Depression Scale (HADS) for anxiety and depression (0-21). A higher score refers to a higher degree of distress.
Baseline and 3 months
Mental health
Time Frame: Baseline and 9 months
Change in the Hospital and Anxiety Depression Scale (HADS) for anxiety and depression (0-21). A higher score refers to a higher degree of distress.
Baseline and 9 months
Enthesites
Time Frame: Baseline and 3 months
Change in the Entesiter MASES entesit index. Palpation of 13 body sites for tenderness. (0= no tenderness, 1= tenderness presented) Higher scores indicate more widespread/tender enthesitis.
Baseline and 3 months
Enthesites
Time Frame: Baseline and 9 months
Change in the Entesiter MASES entesit index. Palpation of 13 body sites for tenderness. (0= no tenderness, 1= tenderness presented). Higher scores indicate more widespread/tender enthesitis.
Baseline and 9 months
Skin involvement
Time Frame: Baseline and 3 months
Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.
Baseline and 3 months
Skin involvement
Time Frame: Baseline and 9 months
Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.
Baseline and 9 months
Homeostatic model assessment of insulin resistance (HOMA IR)
Time Frame: Baseline and 3 monhts
Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report Homeostatic model assessment of insulin resistance (HOMA IR).
Baseline and 3 monhts
Homeostatic model assessment of insulin resistance (HOMA IR)
Time Frame: Baseline and 9 months
Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report Homeostatic model assessment of insulin resistance (HOMA IR).
Baseline and 9 months
Disease activity
Time Frame: Baseline and 3 months
Change in Disease Activity index for PSoriatic Arthritis (DAPSA) score. Calculated by summing 66/68 joints (swollen, tender), patient global assessment (VAS), pain (VAS)and CRP). A higher value indicates a higher disease activity. (Minimum: 0=no disease activity, >28= high disease activity).
Baseline and 3 months
Disease activity
Time Frame: Baseline and 9 months
Change in Disease Activity index for PSoriatic Arthritis (DAPSA) score. Calculated by summing 66/68 joints (swollen, tender), patient global assessment (VAS), pain (VAS)and CRP). A higher value indicates a higher disease activity. (Minimum: 0=no disease activity, >28= high disease activity).
Baseline and 9 months
Activity limitations
Time Frame: Baseline and 3 months
Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations
Baseline and 3 months
Activity limitations
Time Frame: Baseline and 9 months
Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations.
Baseline and 9 months
Physical activity
Time Frame: Baseline and 3 months
Change in self-reported weekly physical activity assessed with the International Physical Activity Questionnaire (IPAQ)-Short Form. Time spent in low, moderate, and vigorous activity is summed within each intensity category. (According to WHO guidelines, ≥150 minutes of moderate or ≥75 minutes of vigorous activity per week qualifies as health-enhancing physical activity).
Baseline and 3 months
Physical activity
Time Frame: Baseline and 9 months
Change in self-reported weekly physical activity assessed with the International Physical Activity Questionnaire (IPAQ)-Short Form. Time spent in low, moderate, and vigorous activity is summed within each intensity category. (According to WHO guidelines, ≥150 minutes of moderate or ≥75 minutes of vigorous activity per week qualifies as health-enhancing physical activity).
Baseline and 9 months
Disease related symptoms
Time Frame: Baseline and 3 months
Patient Global Impression of Change (PGIC) scale (0-7) to adress changes in symtoms. Rating from very much improved (7) to very much worse (1).
Baseline and 3 months
Disease related symptoms
Time Frame: Baseline and 9 months
Patient Global Impression of Change (PGIC) scale (0-7) to adress changes in symtoms. Rating from very much improved (7) to very much worse (1).
Baseline and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Annelie Bilberg, Assoc. Prof., Sahlgrenska University Hospital, Gothenburg

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Vastra Gotaland record 286312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

The data will become available as following, starting 6 months after publication and end 5 years after publication.

IPD Sharing Access Criteria

The requests will be reviewed by the P.I. and the steering committee. Study plans on meta-analyses generating new knowledge on exercise in persons with rheumatic diseases will be approved.

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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