Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus
NCT ID: NCT06166199
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-11-01
2026-12-31
Brief Summary
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Detailed Description
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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?
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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High-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.
Control group
Both the control group and the HIIT combined with resistance training group receive standard care.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Swedish Rheumatism Association
UNKNOWN
Region Örebro County
OTHER
County Council of Norrbotten, Sweden
OTHER_GOV
Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Carina Boström
Associate professor, university lecturer
Principal Investigators
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Carina M Boström, Dr
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Carina Boström
Stockholm, Huddinge, Sweden
Countries
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Central Contacts
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Facility Contacts
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Carina M Boström, Dr
Role: primary
Ioannis Parodis, Dr
Role: backup
Other Identifiers
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2021-05523-01
Identifier Type: -
Identifier Source: org_study_id