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Psoriatic ArthritisPsA-HIITNCT07352696

Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis

A study testing Exercise program in people with Psoriatic Arthritis, run by Vastra Gotaland Region at 2 sites in Sweden.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial summary

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. 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?
Exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
2 sitesSweden
Study dates
26 Jan 2026to Dec 2028
Phase
Interventional

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

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden2 sites

  • Sahlgrenska University hospital

    Gothenburg

  • Skaraborgs sjukvård, Skövde

    Skövde

Other trials in Sweden

About this study

Official title: 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.

Being tested
Exercise program
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise programBehavioural

    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.

Study groups in NCT07352696
Study groupRoleWhat they receive
Exercise groupExperimentalCardiorespiratory and strength training, 2-3 sessions per week for a total of 12 weeks.
Receives: Behavioral: Exercise program
Control groupNo interventionCare as usual, plus individualized counseling for health-promoting physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiopulmonary function

    Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity.

    Measured: Baseline and 3 month

  2. Cardiopulmonary function

    Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity)

    Measured: Baseline and 9 month

Secondary outcomes (59)

  1. Waist circumference

    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.

    Measured: Baseline and 3 months

  2. Waist circumference

    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.

    Measured: Baseline and 9 months

  3. Body mass index (BMI)

    Change in Body Mass Index (BMI). Weight and height will be combined to report BMI (kg/m2). A higher score indicate higher relative weight.

    Measured: Baseline and 3 months

  4. Body mass index (BMI)

    Change in Body Mass Index (BMI). Weight and height will be combined to report BMI (kg/m2). A higher score indicate higher relative weight.

    Measured: Baseline and 9 months

  5. Body composition

    Change in total leanmass (%) and fatmass (%) assessed with Bioelectrical Impedance Analysis. Higher value indicate higher total leanmass and fatmass

    Measured: Baseline and 3 months

  6. Body composition

    Change in total leanmass (%) and fatmass (%) assessed with Bioelectrical Impedance Analysis. Higher value indicate higher total leanmass and fatmass

    Measured: Baseline and 9 months

  7. Triglycerides

    Change in triglycerides (mmol/L)

    Measured: Baseline and 3 months

  8. Triglycerides

    Change in triglycerides (mmol/L)

    Measured: Baseline and 9 months

  9. High-density lipoprotein cholesterol (HDL-C)

    Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)

    Measured: Baseline and 3 months

  10. High-density lipoprotein cholesterol (HDL-C)

    Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)

    Measured: Baseline and 9 months

  11. Low-density lipoprotein cholesterol (LDL-C)

    Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)

    Measured: Baseline and 3 months

  12. Low-density lipoprotein cholesterol (LDL-C)

    Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)

    Measured: Baseline and 9 months

  13. Total cholesterol

    Change in total cholesterol (mmol/L)

    Measured: Baseline and 3 months

  14. Total cholesterol

    Change in total cholesterol (mmol/L)

    Measured: Baseline and 9 months

  15. Glycosylation level of hemoglobin (HbA1c)

    Glycosylation level of hemoglobin (HbA1c) (mmol/mol)

    Measured: Baseline and 3 months

  16. Glycosylation level of hemoglobin (HbA1c)

    Glycosylation level of hemoglobin (HbA1c) (mmol/mol)

    Measured: Baseline and 9 months

  17. 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 Homeostatic model assessment of insulin resistance (HOMA IR).

    Measured: Baseline and 3 monhts

  18. 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 Homeostatic model assessment of insulin resistance (HOMA IR).

    Measured: Baseline and 9 months

  19. Erythrocyte Sedimentation Rate (ESR)

    Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.

    Measured: Baseline and 3 months

  20. Erythrocyte Sedimentation Rate (ESR)

    Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.

    Measured: Baseline and 9 months

  21. C-Reactive Protein (CRP)

    Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.

    Measured: Baseline and 3 months

  22. C-Reactive Protein (CRP)

    Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.

    Measured: Baseline and 9 months

  23. Cytokine levels

    Change in inflammatory cytokines such as Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL).

    Measured: Baseline and 3 months

  24. Disease activity

    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).

    Measured: Baseline and 3 months

  25. Disease activity

    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).

    Measured: Baseline and 9 months

  26. Muscle function lower extremities

    Change in the one minute sit-to-stand test (STS). Higher numbers of complete rises indicate better muscle function in lower extremities.

    Measured: Baseline and 3 months

  27. Muscle function lower extremities

    Change in the one minute sit-to-stand test (STS). Higher numbers of complete rises indicate better muscle function in lower extremities.

    Measured: Baseline and 9 months

  28. Handgrip strength

    Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.

    Measured: Baseline and 3 months

  29. Handgrip strength

    Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.

    Measured: Baseline and 9 months

  30. Activity limitations

    Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations

    Measured: Baseline and 3 months

  31. Activity limitations

    Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations.

    Measured: Baseline and 9 months

  32. Physical function

    Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations

    Measured: Baseline and 3 months

  33. Physical function

    Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations

    Measured: Baseline and 9 months

  34. Physical activity

    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).

    Measured: Baseline and 3 months

  35. Physical activity

    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).

    Measured: Baseline and 9 months

  36. Attitude to exercise

    Change in exercise believe assessed with the Exercise Health Beliefs questionnaire (20-100), Higher score represents stronger exercise beliefs.

    Measured: Baseline and 3 months

  37. Attitude to exercise

    Change in exercise believe assessed with the Exercise Health Beliefs questionnaire (20-100), Higher score represents stronger exercise beliefs.

    Measured: Baseline and 9 months

  38. Emotional experience of exercise

    Change in the Physical Activity Enjoyment Scale (PACES) (18-126). Higher score indicate higher degreee of enjoyment and pleasure related to exercising.

    Measured: Baseline and 3 months

  39. Emotional experience of exercise

    Change in the Physical Activity Enjoyment Scale (PACES) (18-126). Higher score indicate higher degreee of enjoyment and pleasure related to exercising.

    Measured: Baseline and 9 months

  40. Sleep quality

    Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.

    Measured: Baseline and 3 months

  41. Sleep quality

    Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.

    Measured: Baseline and 9 months

  42. Fatigue

    Change in The Multiple Fatigue Inventory (MFI-20), 4-20 for each subscale, Higher score indicates a higher degree of fatigue.

    Measured: Baseline and 3 months

  43. Fatigue

    Change in The Multiple Fatigue Inventory (MFI-20), 4-20 for each subscale, Higher score indicates a higher degree of fatigue

    Measured: Baseline and 9 months

  44. Pain intensity

    Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.

    Measured: Baseline and 3 months

  45. Pain intensity

    Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.

    Measured: Baseline and 9 months

  46. Global health

    Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health

    Measured: Baseline and 3 months

  47. Global health

    Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health

    Measured: Baseline and 9 months

  48. Health related quality of life

    Change in the 36-item Short Form Health Survey (SF-36) questionnare (0-100). A higher score indicate better health related quality of life

    Measured: Baseline and 3 months

  49. Health related quality of life

    Change in the 36-item Short Form Health Survey (SF-36) questionnare (0-100). A higher score indicate better health related quality of life

    Measured: Baseline and 9 months

  50. The impact of the disease on quality of life

    Change in the Dermatology Life Quality Index (DLQI) (0-30). Higher score indicate worse impairment

    Measured: Baseline and 3 months

  51. The impact of the disease on quality of life

    Change in the Dermatology Life Quality Index (DLQI) (0-30). Higher score indicate worse impairment

    Measured: Baseline and 9 months

  52. Mental health

    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.

    Measured: Baseline and 3 months

  53. Mental health

    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.

    Measured: Baseline and 9 months

  54. Disease related symptoms

    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).

    Measured: Baseline and 3 months

  55. Disease related symptoms

    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).

    Measured: Baseline and 9 months

  56. Enthesites

    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.

    Measured: Baseline and 3 months

  57. Enthesites

    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.

    Measured: Baseline and 9 months

  58. Skin involvement

    Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.

    Measured: Baseline and 3 months

  59. Skin involvement

    Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.

    Measured: Baseline and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start26 Jan 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Treatment versus care as usual
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07352696
Sponsor's protocol ID
Vastra Gotaland record 286312
Acronym
PsA-HIIT
Status last verified
Oct 2026
First submitted
15 Dec 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
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

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