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

Lupus Erythematosus, Systemic Clinical Trial

— SLE-HIIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166199
• Other study ID #: 2021-05523-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Karolinska Institutet
• Contact: Carina M Boström, Dr
• Phone: 046 0722006321
• Email: carina.bostrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	Carina Boström	Stockholm	Huddinge

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska Institutet	County Council of Norrbotten, Sweden, Karolinska University Hospital, Region Örebro County, Swedish Rheumatism Association

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	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
Other	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
Other	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
Other	Weight	Weight in kilograms	Baseline, months 3 and 6
Other	Height	Height in meters	Baseline
Other	Body Mass Index (BMI)	Weight in kilograms divided by the height in metres squared	Baseline, months 3 and 6
Other	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
Primary	Aerobic capacity	Aerobic capacity is measured as maximal oxygen uptake when performing a maximal symptom-limited, ergometercycle exercise test	Baseline, months 3 and 6
Primary	Physical capacity	Physical capacity are measured when performing a symptom-limited, ergometercycle exercise test	Baseline, months 3 and 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Inflammatory markers	Blood samples are collected before and after maximal ergometercycle exercise test	Baseline, months 3 and 6
Secondary	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
Secondary	Blood pressure	Resting diastolic and systolic blood pressure	Baseline, month 3 and 6