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L'essai clinique NCT06166199 (SLE-HIIT) pour Lupus érythémateux systémique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Institut KarolinskaEffects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus (SLE-HIIT)
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L'étude clinique NCT06166199 (SLE-HIIT) est un essai interventionnel pour Lupus érythémateux systémique. Son statut actuel est : en recrutement. L'étude a débuté le 1 novembre 2022 et vise à recruter 40 participants. Dirigé par l'Institut Karolinska, l'essai devrait être terminé d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 décembre 2023.
Résumé succinct
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 détaillée
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:
- 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?
- 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.
- How do individuals with SLE experience HIIT combined with resistance exercises ? What are the perceived barriers and facilitators for performing and maintaining such training?
Titre officiel
Effects of High-intensity Interval Training Combined With Resistance Training in Patients With Systemic Lupus Erythematosus
Conditions
Lupus érythémateux systémiqueAutres identifiants de l'essai
- SLE-HIIT
- 2021-05523-01
Numéro NCT
Date de début (réel)
2022-11-01
Dernière mise à jour publiée
2023-12-12
Date de fin (estimée)
2026-12-31
Inscription (estimée)
40
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Physical exercise
High-intensity interval training
Resistance training
Quality of life
Aerobic capacity
Fatigue
Disease activity
Patients experiences
Inflammatory markers
Muscle function
Depressive symptoms
High-intensity interval training
Resistance training
Quality of life
Aerobic capacity
Fatigue
Disease activity
Patients experiences
Inflammatory markers
Muscle function
Depressive symptoms
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalHigh-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. |
Aucune interventionControl group Both the control group and the HIIT combined with resistance training group receive standard care. | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- ≥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
Institut Karolinska459 essais cliniques actifs à explorer- 🏛️Swedish Rheumatism Association
- 🏛️Region Örebro County
- 🏛️County Council of Norrbotten, Sweden
- 🏥Karolinska University Hospital
Partie responsable de l'essai
Carina Boström, Investigateur principal, Associate professor, university lecturer, Karolinska Institutet
Contact central de l'essai
Contact: Carina M Boström, Dr, 046 0722006321, [email protected]
Contact: Ioannis Parodis, Dr, 046 0722321322, [email protected]
1 Centres de l'essai dans 1 pays
Huddinge
Carina Boström, Stockholm, Huddinge, 141 83, Sweden
Carina M Boström, Dr, Contact, 046 0722006321, [email protected]
Ioannis Parodis, Dr, Contact, 046 0722321322, [email protected]
En recrutement