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

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: Not yet recruiting
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Behavioral: Exercise program

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annelie Bilberg, Assoc. Prof.; Phone Number: +4631-3421195; Email: annelie.bilberg@vgregion.se
• Study Contact Backup: Name: Eva Klingberg, Assoc. Prof.; Email: eva.klingberg@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
    • Contact: Annelie Bilberg, Associate professor; Phone Number: +46313421195; Email: annelie.bilberg@vgregion.se
    • Principal Investigator: Annelie Bilberg, Associate professor
  • Skövde, Sweden
    • Skaraborgs sjukvård, Skövde
    • Contact: Daniel Glinatsi, MD, PhD; Email: daniel.glinatsi@vgregion.se

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary function	Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity.	Baseline and 3 month
Cardiopulmonary function	Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity)	Baseline and 9 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months
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.	Baseline and 9 months
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.	Baseline and 3 months
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.	Baseline and 9 months
Body composition	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	Change in total leanmass (%) and fatmass (%) assessed with Bioelectrical Impedance Analysis. Higher value indicate higher total leanmass and fatmass	Baseline and 9 months
Triglycerides	Change in triglycerides (mmol/L)	Baseline and 3 months
Triglycerides	Change in triglycerides (mmol/L)	Baseline and 9 months
High-density lipoprotein cholesterol (HDL-C)	Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)	Baseline and 3 months
High-density lipoprotein cholesterol (HDL-C)	Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)	Baseline and 9 months
Low-density lipoprotein cholesterol (LDL-C)	Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)	Baseline and 3 months
Low-density lipoprotein cholesterol (LDL-C)	Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)	Baseline and 9 months
Total cholesterol	Change in total cholesterol (mmol/L)	Baseline and 3 months
Total cholesterol	Change in total cholesterol (mmol/L)	Baseline and 9 months
Glycosylation level of hemoglobin (HbA1c)	Glycosylation level of hemoglobin (HbA1c) (mmol/mol)	Baseline and 3 months
Glycosylation level of hemoglobin (HbA1c)	Glycosylation level of hemoglobin (HbA1c) (mmol/mol)	Baseline and 9 months
Erythrocyte Sedimentation Rate (ESR)	Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.	Baseline and 3 months
Erythrocyte Sedimentation Rate (ESR)	Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.	Baseline and 9 months
C-Reactive Protein (CRP)	Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.	Baseline and 3 months
C-Reactive Protein (CRP)	Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.	Baseline and 9 months
Cytokine levels	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	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	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	Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.	Baseline and 3 months
Handgrip strength	Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.	Baseline and 9 months
Physical function	Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations	Baseline and 3 months
Physical function	Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations	Baseline and 9 months
Attitude to exercise	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	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	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	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	Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.	Baseline and 3 months
Sleep quality	Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.	Baseline and 9 months
Fatigue	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	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	Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.	Baseline and 3 months
Pain intensity	Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.	Baseline and 9 months
Global health	Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health	Baseline and 3 months
Global health	Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health	Baseline and 9 months
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	Baseline and 3 months
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	Baseline and 9 months
The impact of the disease on quality of life	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	Change in the Dermatology Life Quality Index (DLQI) (0-30). Higher score indicate worse impairment	Baseline and 9 months
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.	Baseline and 3 months
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.	Baseline and 9 months
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.	Baseline and 3 months
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.	Baseline and 9 months
Skin involvement	Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.	Baseline and 3 months
Skin involvement	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)	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)	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	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	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	Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations	Baseline and 3 months
Activity limitations	Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations.	Baseline and 9 months
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).	Baseline and 3 months
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).	Baseline and 9 months
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).	Baseline and 3 months
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).	Baseline and 9 months

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Annelie Bilberg, Assoc. Prof., Sahlgrenska University Hospital, Gothenburg

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID 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