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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annelie Bilberg, Assoc. Prof. | Contact | +4631-3421195 | annelie.bilberg@vgregion.se | |
| Eva Klingberg, Assoc. Prof. | Contact | eva.klingberg@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Annelie Bilberg, Assoc. Prof. | Sahlgrenska University hospital, Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University hospital | Gothenburg | Sweden |
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
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The data will become available as following, starting 6 months after publication and end 5 years after publication.
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.
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Treatment versus care as usual
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Single blinded
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Skaraborgs sjukvård, Skövde | Skövde | Sweden |
|
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |