Psoriatic Arthritis
Conditions
Brief 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.
Interventions
BEHAVIORALExercise 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.
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Single blinded
Intervention model description
Treatment versus care as usual
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiopulmonary function | Baseline and 3 month | Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-Reactive Protein (CRP) | Baseline and 3 months | Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation. |
| 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. |
| 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 composition | Baseline and 3 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) |
| High-density lipoprotein cholesterol (HDL-C) | Baseline and 3 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) |
| Total cholesterol | Baseline and 3 months | Change in total cholesterol (mmol/L) |
| Glycosylation level of hemoglobin (HbA1c) | Baseline and 3 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). |
| Erythrocyte Sedimentation Rate (ESR) | Baseline and 3 months | Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation. |
| 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). |
| 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. |
| Handgrip strength | Baseline and 3 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 |
| Physical function | Baseline and 3 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). |
| 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. |
| 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. |
| Sleep quality | Baseline and 3 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. |
| Pain intensity | Baseline and 3 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 |
| 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 |
| 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 |
| 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. |
| 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). |
| 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. |
| 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). |
| Skin involvement | Baseline and 3 months | Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions. |
Countries
Sweden
Contacts
CONTACTAnnelie Bilberg, Assoc. Prof.
CONTACTEva Klingberg, Assoc. Prof.
PRINCIPAL_INVESTIGATORAnnelie Bilberg, Assoc. Prof.
Sahlgrenska University hospital, Gothenburg
Outcome results
None listed