NCT05451979Toboroz
HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)
High Intensity Interval Training in Pediatric Heart Transplant Recipients: Evaluating a Novel Telemedicine Video Game-Linked Exercise Platform (MedBIKE™)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 13.
Rövid összefoglaló (regiszter, angolul)
Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive with a need for re-transplantation 17-years following the initial transplant. With improved short- and medium-term outcomes, focus has shifted towards optimizing long-term survival and reducing transplant-associated morbidities. This includes strategies aimed at optimizing cardiorespiratory fitness and physical activity levels. Pediatric and adult HTRs have reduced exercise capacity compared with the general population. Previous groups have shown gradual improvements in heart rate response to exercise and exercise capacity in pediatric HTRs. However, after an initial improvement, exercise capacity appears to plateau, or even decline in pediatric HTRs, and remains sub-optimal compared with the general population. Most exercise interventions in HTRs to date have focused on moderate-intensity continuous exercise (MICE), with some resistance components incorporated. More recently, high-intensity interval training (HIIT), consisting of short, intense bursts of exercise with rest periods, has been explored in the adult HTR population, with findings to date suggesting that it may yield greater improvements in cardiorespiratory fitness compared with MICE. Exercise interventions, particularly HIIT interventions, have consistently shown clinically important improvements in exercise capacity in adult HTRs that are linked with improved long-term post-transplant outcomes and well-being. Unfortunately, trials of exercise interventions in pediatric HTRs remain lacking. This study team is proposing an assessment of the feasibility of a home-based HIIT exercise program using a novel telemedicine-enable video game linked customizable cycle ergometer (MedBIKE™).
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 10 (tervezett)
- Első benyújtás
- 2021. nov. 8.
- Kezdés
- 2022. febr. 22.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- University of Alberta
- Betegségek
- Akut limfoid leukémia (ALL), Gyermekkori daganatok
- NCT-szám
- NCT05451979
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 10
- 2022. febr. 22. és az elsődleges befejezés (2027. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Episode of clinical antibody- or cellular-mediated rejection within 3-months of the baseline assessment
- Previous involvement in a cardiac rehabilitation or exercise intervention program
- Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (<20 mmHg) or a systolic BP >200 mmHg, or symptoms of chest pain or syncope
Más betegség
- History of multiorgan transplant
- History of chest pain on exertion
- Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block (Mobitz II or worse))
- New York Heart Association class II or worse symptoms
- Active medical inter-current illness limiting ability to participate
- Cognitive impairment limiting the communication needed for the HIIT program
Egyéb
- Non-English speaking (thus limiting communication during the MedBIKE™ sessions)
- Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)
- Adult unavailable to supervise the home-based exercise sessions
- Primary cardiologist has exercise restricted the participant or counsels against participation
- Resting arterial saturation <85% or oxygen requirements
- Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram
- Unrepaired/unpalliated CHD
- Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
Kiket keres a vizsgálat
- Pediatric heart transplant recipients, at least 6-months post heart transplantation
- Aged 10-18 years
Életkor a regiszterben: 10 év – 18 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Alberta | Edmonton | Kanada | Toboroz |
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