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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
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.
Sahlgrenska University hospital
Gothenburg, Sweden
Skaraborgs sjukvård, Skövde
Skövde, Sweden
Cardiopulmonary function
Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity.
Time frame: Baseline and 3 month
Cardiopulmonary function
Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity)
Time frame: Baseline and 9 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline and 9 months
Triglycerides
Change in triglycerides (mmol/L)
Time frame: Baseline and 3 months
Triglycerides
Change in triglycerides (mmol/L)
Time frame: Baseline and 9 months
High-density lipoprotein cholesterol (HDL-C)
Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)
Time frame: Baseline and 3 months
High-density lipoprotein cholesterol (HDL-C)
Change in high-density lipoprotein cholesterol (HDL-C) (mmol/L)
Time frame: Baseline and 9 months
Low-density lipoprotein cholesterol (LDL-C)
Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Time frame: Baseline and 3 months
Low-density lipoprotein cholesterol (LDL-C)
Change in low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Time frame: Baseline and 9 months
Total cholesterol
Change in total cholesterol (mmol/L)
Time frame: Baseline and 3 months
Total cholesterol
Change in total cholesterol (mmol/L)
Time frame: Baseline and 9 months
Glycosylation level of hemoglobin (HbA1c)
Glycosylation level of hemoglobin (HbA1c) (mmol/mol)
Time frame: Baseline and 3 months
Glycosylation level of hemoglobin (HbA1c)
Glycosylation level of hemoglobin (HbA1c) (mmol/mol)
Time frame: 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).
Time frame: 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).
Time frame: Baseline and 9 months
Erythrocyte Sedimentation Rate (ESR)
Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.
Time frame: Baseline and 3 months
Erythrocyte Sedimentation Rate (ESR)
Change in level of erytrocyte rate (ESR) (mm/h). Higher score indicate higher degree of inflammation.
Time frame: Baseline and 9 months
C-Reactive Protein (CRP)
Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.
Time frame: Baseline and 3 months
C-Reactive Protein (CRP)
Change in level of of high sensitivity CRP (mg/L). Higher score indicate higher inflammation.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and 9 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.
Time frame: 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.
Time frame: Baseline and 9 months
Handgrip strength
Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.
Time frame: Baseline and 3 months
Handgrip strength
Change in grip strength measured with a dynamometer (newton). Higher value indicate better grip strength.
Time frame: Baseline and 9 months
Activity limitations
Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations
Time frame: Baseline and 3 months
Activity limitations
Change in Health Assessment Questionnaire (HAQ) (0-3). A higher score indicates more activity limitations.
Time frame: Baseline and 9 months
Physical function
Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations
Time frame: Baseline and 3 months
Physical function
Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10). Higher score indicate more physical limitations
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 9 months
Sleep quality
Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.
Time frame: Baseline and 3 months
Sleep quality
Change in Pittsburgh Sleep Quality Index (PSQI) (0-21), Higher score indicate worse sleep quality.
Time frame: 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.
Time frame: 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
Time frame: Baseline and 9 months
Pain intensity
Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.
Time frame: Baseline and 3 months
Pain intensity
Visual Analogue Scale (VAS) (0-100), Higher score indicate worse pain.
Time frame: Baseline and 9 months
Global health
Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health
Time frame: Baseline and 3 months
Global health
Change in Visual Analogue Scale (VAS) (0-100), Higher score indicate worse health
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 9 months
Skin involvement
Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.
Time frame: Baseline and 3 months
Skin involvement
Skin involvement evaluated using the Body surface area (BSA), percentage of total body surface affected by lesions.
Time frame: Baseline and 9 months
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