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

NCT06166199 | Recruiting

• 1 other identifier: 2021-05523-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lupus Erythematosus, Systemic

Keywords

Physical exercise; High-intensity interval training; Resistance training; Quality of life; Aerobic capacity; Fatigue; Disease activity; Patients experiences; Inflammatory markers; Muscle function; Depressive symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Muscle function upper extremity

  Baseline, months 3 and 6

• Self-reported disease activity

  Baseline, months 3 and 6

• Fatigue

  Baseline, months 3 and 6

• Anxiety and depressive symptoms

  Baseline, months 3 and 6

• Quality of life in SLE

  Baseline, months 3 and 6

Other Outcomes (8)

• 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

  Baseline. For some variables, such as medical treatment, also months 3 and 6

• Physical activity

  Baseline, months 3 and 6

Study Arms (2)

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.

Behavioral: HIIT combined with resistance training

Control group

NO INTERVENTION

Both the control group and the HIIT combined with resistance training group receive standard care.

Interventions

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.

High-intensity interval training (HIIT) combined with resistance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Rheumatism Association: collaborator
• Region Örebro County: collaborator
• County Council of Norrbotten, Sweden: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Carina Boström

Stockholm, Huddinge, 141 83, Sweden

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Motor Activity; Fatigue; Depression

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carina M Boström, Dr

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina M Boström, Dr

CONTACT

046 0722006321; carina.bostrom@ki.se

Ioannis Parodis, Dr

CONTACT

046 0722321322; ioannis.parodis@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors are blinded for which patient is randomised to which group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, university lecturer

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 12, 2023
• Study Start: November 1, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)