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क्लिनिकल ट्रायल NCT06166199 (SLE-HIIT) के लिए लुपस एरिथेमेटोसस, प्रणालीगत वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus (SLE-HIIT)

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT06166199 (SLE-HIIT) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो लुपस एरिथेमेटोसस, प्रणालीगत से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 1 नवंबर 2022 को हुई थी, और इसमें कुल 40 प्रतिभागियों के नामांकन की योजना है। करोलिंस्का संस्थान इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 12 दिसंबर 2023 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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
विस्तृत विवरण

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:

  1. What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding aerobic capacity, muscle function, physician and patient reported disease activity, fatigue, depressive symptoms, and quality of life?
  2. What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding inflammatory markers such as interleukin 6 and 10 and interferon molecules? Both acute exercise test (maximal ergometercycle test) effects as well as the long term effects of training will be evaluated.
  3. How do individuals with SLE experience HIIT combined with resistance exercises ? What are the perceived barriers and facilitators for performing and maintaining such training?
आधिकारिक शीर्षक

Effects of High-intensity Interval Training Combined With Resistance Training in Patients With Systemic Lupus Erythematosus

चिकित्सीय स्थितियाँ
लुपस एरिथेमेटोसस, प्रणालीगत
अन्य अध्ययन आईडी
  • SLE-HIIT
  • 2021-05523-01
NCT नंबर
NCT06166199
अध्ययन प्रारंभ तिथि (वास्तविक)
2022-11-01
अंतिम अद्यतन प्रकाशित
2023-12-12
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-12-31
नामांकन (अनुमानित)
40
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
Physical exercise
High-intensity interval training
Resistance training
Quality of life
Aerobic capacity
Fatigue
Disease activity
Patients experiences
Inflammatory markers
Muscle function
Depressive symptoms
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
एकल अंध
समूह/हस्तक्षेप
प्रतिभागी समूह/हाथहस्तक्षेप/इलाज
प्रयोगात्मकHigh-intensity interval training (HIIT) combined with resistance training
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.
HIIT Combined with Resistance Training
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.
कोई हस्तक्षेप नहींControl group
Both the control group and the HIIT combined with resistance training group receive standard care.
निर्दिष्ट नहीं
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
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
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  • ≥18 years old
  • Fulfilment of the 1982 American College of Rheumatology (ACR) criteria; or 2012 Systemic Lupus International Collaborating Clinics (SLICC/ACR-Damage Index (DI)) classification criteria; or EULAR/ACR criteria; or patients that have received the diagnosis SLE on clinical grounds
  • Low to moderate disease activity, for example defined as a score of ≤5 in the clinical version of the SLE Disease Activity Index 2000 (SLEDAI-2K), i.e., excluding the serological descriptors (anti-dsDNA positivity and low complement levels)
  • Low/minimal or no organ damage, for example defined as a score of ≤3 in the SLICC/ACR DI
  • Stable pharmacological treatment
  • The ability to perform a maximal ergometercycle exercise test
  • Be able to read and understand Swedish

  • Symptoms or signs of cerebro-vascular disease, pulmonary embolus, pulmonary hypertension, pulmonary fibrosis, cardiovascular disease, angina pectoris, myocardial infarction, dyspnea at rest, uncontrolled blood pressure and uncontrolled diabetes within one year prior to study entry. Chronic kidney disease with
  • Patients who fulfil the absolute contraindications for maximal exercise testing according to American Heart Association
  • Patients who cannot perform a maximal ergometercycle exercise test due to the disease
  • Diseases or other conditions that strongly reduce the ability to exercise or that exercise is not recommended
  • Patients who perform regular aerobic fitness training and muscle strength exercise sessions at fixed times, >1 time/week
  • Pregnancy
Karolinska Institutet logoकरोलिंस्का संस्थान459 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिए
  • 🏛️Swedish Rheumatism Association
  • 🏛️Region Örebro County
  • 🏛️County Council of Norrbotten, Sweden
  • 🏥Karolinska University Hospital
अध्ययन उत्तरदायी पक्ष
Carina Boström, मुख्य अन्वेषक, Associate professor, university lecturer, Karolinska Institutet
अध्ययन केंद्रीय संपर्क
संपर्क: Carina M Boström, Dr, 046 0722006321, [email protected]
संपर्क: Ioannis Parodis, Dr, 046 0722321322, [email protected]
1 1 देशों में अध्ययन स्थल

Huddinge

Carina Boström, Stockholm, Huddinge, 141 83, Sweden
Carina M Boström, Dr, संपर्क, 046 0722006321, [email protected]
Ioannis Parodis, Dr, संपर्क, 046 0722321322, [email protected]
भर्ती जारी