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NCT Number: NCT07352696

Combined High-Intensity Aerobic Training and Resistance Training 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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Program

Behavioral

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.

Primary outcomes

  1. Cardiopulmonary function

    Time frame: Baseline and 3 month

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

  2. Cardiopulmonary function

    Time frame: Baseline and 9 month

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. Triglycerides

    Time frame: Baseline and 3 months

    Change in triglycerides (mmol/L)

  8. Triglycerides

    Time frame: Baseline and 9 months

    Change in triglycerides (mmol/L)

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

    Time frame: Baseline and 3 months

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

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

    Time frame: Baseline and 9 months

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

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

    Time frame: Baseline and 3 months

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

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

    Time frame: Baseline and 9 months

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

  13. Total cholesterol

    Time frame: Baseline and 3 months

    Change in total cholesterol (mmol/L)

  14. Total cholesterol

    Time frame: Baseline and 9 months

    Change in total cholesterol (mmol/L)

  15. Glycosylation level of hemoglobin (HbA1c)

    Time frame: Baseline and 3 months

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

  16. Glycosylation level of hemoglobin (HbA1c)

    Time frame: Baseline and 9 months

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

  17. 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).

  18. 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).

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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).

  24. 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).

  25. 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).

  26. 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.

  27. 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.

  28. Handgrip strength

    Time frame: Baseline and 3 months

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

  29. Handgrip strength

    Time frame: Baseline and 9 months

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

  30. Activity limitations

    Time frame: Baseline and 3 months

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

  31. Activity limitations

    Time frame: Baseline and 9 months

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

  32. 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

  33. 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

  34. 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).

  35. 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).

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. Sleep quality

    Time frame: Baseline and 3 months

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

  41. Sleep quality

    Time frame: Baseline and 9 months

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

  42. 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.

  43. 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

  44. Pain intensity

    Time frame: Baseline and 3 months

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

  45. Pain intensity

    Time frame: Baseline and 9 months

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

  46. Global health

    Time frame: Baseline and 3 months

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

  47. Global health

    Time frame: Baseline and 9 months

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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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.

  53. 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.

  54. 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).

  55. 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).

  56. 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.

  57. 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.

  58. 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.

  59. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annelie Bilberg, Assoc. Prof.

CONTACT

[email protected]

+4631-3421195

Eva Klingberg, Assoc. Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Acronym: PsA-HIIT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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