Effects of Combined High-Intensity Aerobic Training and Resistance Training on Cardiovascular and Metabolic Health in Psoriatic Arthritis
| Registry | NCT07352696, acronym PsA-HIIT |
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 88 (Estimated) |
| Sponsor | Vastra Gotaland Region (Other gov) |
| Conditions | Psoriatic Arthritis |
| Interventions | Exercise program (Behavioral) |
| Dates | start 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 |
| Locations | 2 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
| Arm | Type | Interventions | Description |
|---|
| Exercise group | Experimental | Behavioral: Exercise program | Cardiorespiratory and strength training, 2-3 sessions per week for a total of 12 weeks. |
| Control group | No intervention | | Care 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)
| Facility | City | Country | Status |
|---|
| Sahlgrenska University hospital | Gothenburg | Sweden | |
| Skaraborgs sjukvård, Skövde | Skövde | Sweden | |
+Investigators