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

NCT07352696 — Not applicable, Not yet recruiting, 88 participants, Vastra Gotaland Region

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

RegistryNCT07352696, acronym PsA-HIIT
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment88 (Estimated)
SponsorVastra Gotaland Region (Other gov)
ConditionsPsoriatic Arthritis
InterventionsExercise program (Behavioral)
Datesstart 2026-02-02 (estimated), primary completion 2027-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-01-20, last updated 2026-01-22
Locations2 sites in Sweden

Related Papers Related Patents Related Grants Related Experts
All trials for Psoriatic Arthritis All trials of Exercise program

-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. 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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+Arms and interventions

ArmTypeInterventionsDescription
Exercise groupExperimentalBehavioral: Exercise programCardiorespiratory and strength training, 2-3 sessions per week for a total of 12 weeks.
Control groupNo interventionCare as usual, plus individualized counseling for health-promoting physical activity
  • 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.

+Outcome measures

Primary outcomes

  • Cardiopulmonary function [Baseline and 3 month]: Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity.
  • Cardiopulmonary function [Baseline and 9 month]: Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity)

Secondary outcomes

  • Waist circumference [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.
  • Waist circumference [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.
  • Body mass index (BMI) [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.
  • Body mass index (BMI) [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.
  • Body composition [Baseline and 3 months]: Change in total leanmass (%) and fatmass (%) assessed with Bioelectrical Impedance Analysis. Higher value indicate higher total leanmass and fatmass
  • Body composition [Baseline and 9 months]: Change in total leanmass (%) and fatmass (%) assessed with Bioelectrical Impedance Analysis. Higher value indicate higher total leanmass and fatmass
  • Triglycerides [Baseline and 3 months]: Change in triglycerides (mmol/L)
  • Triglycerides [Baseline and 9 months]: Change in triglycerides (mmol/L)
  • High-density lipoprotein cholesterol (HDL-C) [Baseline and 3 months]: Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)
  • High-density lipoprotein cholesterol (HDL-C) [Baseline and 9 months]: Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)
  • Low-density lipoprotein cholesterol (LDL-C) [Baseline and 3 months]: Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)
  • Low-density lipoprotein cholesterol (LDL-C) [Baseline and 9 months]: Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)
  • Total cholesterol [Baseline and 3 months]: Change in total cholesterol (mmol/L)
  • Total cholesterol [Baseline and 9 months]: Change in total cholesterol (mmol/L)
  • Glycosylation level of hemoglobin (HbA1c) [Baseline and 3 months]: Glycosylation level of hemoglobin (HbA1c) (mmol/mol)
  • Glycosylation level of hemoglobin (HbA1c) [Baseline and 9 months]: Glycosylation level of hemoglobin (HbA1c) (mmol/mol)
  • Homeostatic model assessment of insulin resistance (HOMA IR) [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).
  • Homeostatic model assessment of insulin resistance (HOMA IR) [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).
  • Erythrocyte Sedimentation Rate (ESR) [Baseline and 3 months]: Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.
  • Erythrocyte Sedimentation Rate (ESR) [Baseline and 9 months]: Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.
  • C-Reactive Protein (CRP) [Baseline and 3 months]: Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.
  • C-Reactive Protein (CRP) [Baseline and 9 months]: Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.
  • Cytokine levels [Baseline and 3 months]: Change in inflammatory cytokines such as Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL).
  • Disease activity [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).
  • Disease activity [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).
  • Muscle function lower extremities [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.
  • Muscle function lower extremities [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.
  • Handgrip strength [Baseline and 3 months]: Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.
  • Handgrip strength [Baseline and 9 months]: Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.
  • Activity limitations [Baseline and 3 months]: Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations
  • Activity limitations [Baseline and 9 months]: Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations.
  • Physical function [Baseline and 3 months]: Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations
  • Physical function [Baseline and 9 months]: Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations
  • Physical activity [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).
  • Physical activity [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).
  • Attitude to exercise [Baseline and 3 months]: Change in exercise believe assessed with the Exercise Health Beliefs questionnaire (20-100), Higher score represents stronger exercise beliefs.
  • Attitude to exercise [Baseline and 9 months]: Change in exercise believe assessed with the Exercise Health Beliefs questionnaire (20-100), Higher score represents stronger exercise beliefs.
  • Emotional experience of exercise [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.
  • Emotional experience of exercise [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.
  • Sleep quality [Baseline and 3 months]: Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.
  • Sleep quality [Baseline and 9 months]: Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.
  • Fatigue [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.
  • Fatigue [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
  • Pain intensity [Baseline and 3 months]: Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.
  • Pain intensity [Baseline and 9 months]: Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.
  • Global health [Baseline and 3 months]: Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health
  • Global health [Baseline and 9 months]: Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health
  • Health related quality of life [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
  • Health related quality of life [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
  • The impact of the disease on quality of life [Baseline and 3 months]: Change in the Dermatology Life Quality Index (DLQI) (0-30). Higher score indicate worse impairment
  • The impact of the disease on quality of life [Baseline and 9 months]: Change in the Dermatology Life Quality Index (DLQI) (0-30). Higher score indicate worse impairment
  • Mental health [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.
  • Mental health [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.
  • Disease related symptoms [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).
  • Disease related symptoms [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).
  • Enthesites [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.
  • Enthesites [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.
  • Skin involvement [Baseline and 3 months]: Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.
  • Skin involvement [Baseline and 9 months]: Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (2)

FacilityCityCountryStatus
Sahlgrenska University hospitalGothenburgSweden
Skaraborgs sjukvård, SkövdeSkövdeSweden

+Investigators