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| Name | Class |
|---|---|
| Swedish Rheumatism Association | UNKNOWN |
| Region Ă–rebro County | OTHER |
| County Council of Norrbotten, Sweden | OTHER_GOV |
| Karolinska University Hospital |
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The aim of this study is to evaluate the safety and effects of high-intensity interval training (HIIT) combined with resistance training in patients with systemic lupus erythematosus
The overall aim of this randomized controlled study, is to evaluate the safety and effects of HIIT combined with resistance exercises on aerobic capacity, muscle function, patient reported outcomes, disease activity and immune function in patients with SLE with low to moderate disease activity and no to little organ damage. The aim is also to explore and describe patient's experiences of the training.
The research questions are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity interval training (HIIT) combined with resistance training | Experimental | Patients with SLE will undergo supervised HIIT on an ergometercycle 4 x 4 minutes interval (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the supervised training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week. Between months 3 and 6 the patients exercise by themselves, 3 times/week, with video-call/telephone support from a physiotherapist once a week. |
|
| Control group | No Intervention | Both the control group and the HIIT combined with resistance training group receive standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIIT combined with resistance training | Behavioral | Patients with SLE will undergo supervised HIIT on an ergometercycle, 4 x 4 minutes interval, (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week. Between months 3 and 6 the patients exercise by themselves, 3 times/week, with video-call/telephone support from a physiotherapist once a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic capacity | Aerobic capacity is measured as maximal oxygen uptake when performing a maximal symptom-limited, ergometercycle exercise test | Baseline, months 3 and 6 |
| Physical capacity | Physical capacity are measured when performing a symptom-limited, ergometercycle exercise test | Baseline, months 3 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle function upper extremity | How many shoulder flexions (0-90 degrees), in a given pace, with a 3 kg (men) or 2 kg (women) dumbbell in the hand is possible to do | Baseline, months 3 and 6 |
| Self-reported disease activity |
| Measure | Description | Time Frame |
|---|---|---|
| Organ damage | Systemic Lupus International Collaborating Clinics (SLICC/ACR-Damage Index). Organ damage last 6 months, assessed by a physician. The points goes from 0-47, the higher the value, the more organ damage | Baseline and 6 months |
| Demographical, clinical and lifestyle behaviour data including age, gender, ethnic origin, and smoking status as well as other for the project important information about the disease such as autoantibody profiles and pharmacological treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carina M Boström, Dr | Contact | 046 0722006321 | carina.bostrom@ki.se | |
| Ioannis Parodis, Dr | Contact | 046 0722321322 | ioannis.parodis@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Carina M Boström, Dr | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carina Boström | Recruiting | Stockholm | Huddinge | 141 83 | Sweden |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System 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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| OTHER |
This is a randomised-controlled single blinded multicenter study. The trial will follow the Consolidated Standards of Reporting Trials, www.consort-statement.org and comprise two arms.
After information of the study and written informed consent, the patients are block-randomised (from the aerobic capacity results) to either an intervention group doing supervised high-intensity interval training combined with resistance training or a control group. Both groups receive standard care.
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The outcomes assessors are blinded for which patient is randomised to which group.
|
The patient-reported questionnaire Systemic Lupus Erythematosus Activity Questionnaire includes three parts. The part about disease symptoms goes from 0-47 points, the higher the points the more disease symptoms. Further there is a question about flares with four answer alternatives, from no flares to serious flares. There is also a numerical rating scale about disease activity on a scale from 0-10, the higher value the higher the disease activity
| Baseline, months 3 and 6 |
| Fatigue | The patient-reported questionnaire Functional Assessment of Chronic Illness Therapy, FACIT-Fatigue goes from 0-52 points, the higher the value, the less the fatigue | Baseline, months 3 and 6 |
| Anxiety and depressive symptoms | The patient-reported questionnaire Hospital Anxiety and Depression scale goes from 0-21 points, the higher the value, the higher the anxiety and depressive symptoms. In the anxiety and depressive symptoms subscales the points goes from 0-6, the higher the value, the higher anxiety and depressive symptoms respectively | Baseline, months 3 and 6 |
| Quality of life in SLE | The patient-reported questionnaire Lupus Quality of life questionnaire goes from 0-100 points, the higher the value the better the quality of life | Baseline, months 3 and 6 |
| Generic Quality of life | The patient-reported questionnaire Short Form Health Survey (SF-36). Each subscale goes from 0-100 points, the higher the value, the higher the quality of life. | Baseline, months 3 and 6 |
| Quality of life and health status | The patient-reported questionnaire EuroQol 5-dimensions (EQ-5D). The index scores goes from -0,594 till 1,000, the higher the value, the higher the quality of life | Baseline, months 3 and 6 |
| Disease activity | SLE Disease Activity Index 2000 (SLEDAI-2K) assessed by a physician, goes from 0-105 points, the higher the value, the higher the disease activity | Baseline, months 3 and 6 |
| Inflammatory markers | Blood samples are collected before and after maximal ergometercycle exercise test | Baseline, months 3 and 6 |
| Health status | The patient-reported questionnaire EuroQol 5-dimensions (EQ-5D)-5L Visual analogue scale, 0-100 mm, the higher the value, the better the health | Baseline, months 3 and 6 |
| Blood pressure | Resting diastolic and systolic blood pressure | Baseline, month 3 and 6 |
A questionnaire developed specific for this project and data from patients medical files |
| Baseline. For some variables, such as medical treatment, also months 3 and 6 |
| Physical activity | The patient-reported questionnaire International Physical Activity Questionnaire addresses the number of days and time spent on physical activity in moderate intensity, vigorous intensity and walking of at least 10-min duration the last 7 days, and also includes time spent sitting on weekdays the last 7 days. The sum score is expressed in physical activity Metabolic Equivalent of Task-minutes per day or week | Baseline, months 3 and 6 |
| Activity-minutes and sitting behaviour | The patient-reported questions about Activity-minutes and sitting behaviour according to the Swedish National Board of Health and Welfare. For the two questions about physical training and exercise with 5 respective 6 answer alternatives, the higher the value, the more time spending training and exercising. The question about sitting have 7 answer alternatives, the higher the value, the less time spent sitting | Baseline, months 3 and 6 |
| Weight | Weight in kilograms | Baseline, months 3 and 6 |
| Height | Height in meters | Baseline |
| Body Mass Index (BMI) | Weight in kilograms divided by the height in metres squared | Baseline, months 3 and 6 |
| Muscle function lower extremity | How many times is it possible to raise from a chair during 30 seconds; the "30 seconds Chair stand test" | Baseline, months 3 and 6 |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| 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 |