Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus (SLE-HIIT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Behavioral: HIIT combined with resistance training

Detailed 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?

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carina M Boström, Dr; Phone Number: 046 0722006321; Email: carina.bostrom@ki.se
• Study Contact Backup: Name: Ioannis Parodis, Dr; Phone Number: 046 0722321322; Email: ioannis.parodis@ki.se

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden, 141 83
      • Recruiting
      • Carina Boström
      • Contact: Carina M Boström, Dr; Phone Number: 046 0722006321; Email: carina.bostrom@ki.se
      • Contact: Ioannis Parodis, Dr; Phone Number: 046 0722321322; Email: ioannis.parodis@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control group; Both the control group and the HIIT combined with resistance training group receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height in meters	Baseline
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	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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Region Örebro County; County Council of Norrbotten, Sweden; Swedish Rheumatism Association
• Investigators: Principal Investigator: Carina M Boström, Dr, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Fatigue; Inflammatory markers; High-intensity interval training; Physical exercise; Aerobic capacity; Disease activity; Resistance training; Muscle function; Depressive symptoms; Patients experiences
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 2021-05523-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No