- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07636343
Eccentric Muscle Training in Cardiac Rehabilitation
Eccentric Muscle Training in Cardiac Rehabilitation: Randomized Controlled Trial to Evaluate Effectiveness and Feasibility in Heart Failure Patients With Reduced Ejection Fraction
The goal of this interventional study is to assess the training effects in a training schedule in which eccentric overload training and eccentric cycle training are used.
Researchers will compare a training program of eccentric overload training and eccentric cycling training with a traditional training program of strength and cardio training in people with heart failure with reduced ejection fraction.
This study will be delivered in a cardiac rehabilitation setting.
Přehled studie
Postavení
Detailní popis
Patients with HFrEF experience in general more difficulties completing exercise training trajectory because of low physical fitness and multiple comorbidies.
In this study traditional exercise capacity outcomes are assessed eg. endurance capacity, muscle strength and muscle mass in patients with HFrEF.
It is hypothesized that greater muscle strength and muscle mass are obtained by eccentric muscle training in comparison with conventional training because higher training volumes can be used with a lower metabolic demand.
Possibly, a better outcome regarding muscle function and mass will influence VO2 peak and functionality in this patient population.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Wendy Hens, PhD
- Telefonní číslo: 0032 3 275 73 89
- E-mail: wendy.hens@uza.be
Studijní místa
-
-
-
Edegem, Belgie, 2850
- Nábor
- UHAntwerp
-
Kontakt:
- Wendy Hens, PhD
- Telefonní číslo: 0032 3 275 73 89
- E-mail: wendy.hens@uza.be
-
Kontakt:
- E-mail: wendy.hens@uza.be
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- HFrEF patients with ejection fraction <40%
- Exercise intolerance (<85% of predicted VO2 peak)
- clinically stable for > 6 weeks, optimal medical treatment for > 6 weeks
Exclusion Criteria:
- Contra indications for cardiac exercise rehabilitation as per consensus guidelines and recommendations
- Musculoskeletal disorders that hamper (progression in) strength training
- Non-stabilized acute coronary syndrome
- Current acute heart failure (decompensation)
- Patient having sustained a recent (<3 months) procedure that could act as a confounder to increase VO2peak (i.e., coronary artery bypass graft surgery, percutaneous coronary intervention, cardiac resynchronization therapy, valve surgery or reparation)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Eccentric strength training + cardio
45 sessions experimental protocol
|
progressive following protocol, 10min
dynamic strength training + eccentric overload, progressive over time, 3sets*10reps (15-20min)
aerobic training, progressive over time, 10 min
|
|
Aktivní komparátor: Traditional strength training + cardio
45 sessions traditional cardiac rehabilitation
|
aerobic training, progressive over time, 10 min
aerobic training, progressive following protocol, 10 min
dynamic strength training, progression over time, 15-20 min
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
1Repetition Maximum (=RM) leg press (kg)
Časové okno: pre (baseline) + post (15 weeks)
|
One repetition maximum on leg press device Technogym BioCircuit. The patient is positioned correctly on the leg press (back supported, feet on platform in standardized way so that repeated tests are in the same position). The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg). |
pre (baseline) + post (15 weeks)
|
|
1Repetition Maximum (=RM) Low Row (kg)
Časové okno: pre (baseline) + post (15weeks)
|
One repetition maximum on the low row device Technogym BioCircuit. The patient sits with chest supported, feet on the ground, and grips the handles with arms extended. The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single lift as the 1RM (kg). |
pre (baseline) + post (15weeks)
|
|
1Repetition Maximum (=RM) chest press (kg)
Časové okno: pre (baseline) + post (15weeks)
|
One repetition maximum on chest press device Technogym BioCircuit.
The patient is positioned correctly on the chest press (back supported, feet on the ground in standardized way so that repeated tests are in the same position).
The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm.
The system identifies the maximum successful single push as the 1RM (kg).
|
pre (baseline) + post (15weeks)
|
|
1Repetition Maximum (=RM) vertical traction (kg)
Časové okno: pre (baseline) + post (15weeks)
|
One repetition maximum on vertical traction device Technogym BioCircuit. The patient is positioned correctly on the vertical traction (back supported, feet on the ground in standardized way so that repeated tests are in the same position). The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg). |
pre (baseline) + post (15weeks)
|
|
Handgrip strength
Časové okno: pre (baseline) + post (15 weeks)
|
The Jamar handgrip dynamometer is used to measure grip strength in a standardized way ( 90° flex elbow, forearm neutral, and wrist slightly extended). 3 trials per hand are performed, with 10seconds rest in between. The average value is recorded as grip strength. |
pre (baseline) + post (15 weeks)
|
|
Isometric Qceps peak torque (Nm)
Časové okno: pre (baseline) + post (15weeks)
|
The subject is seated in the Biodex System dynamometer and securely strapped (trunk, pelvis, thigh). The dynamometer axis is aligned with the knee joint axis (lateral femoral epicondyle). The knee is fixed at 60° of flexion (0° = full extension). The lower leg is attached to the lever arm just above the ankle. The subject performs a maximal isometric knee extension (pushing against the immovable arm) for 3seconds. 3 tests are done with 10seconds rest in between. The highest torque value (Nm) recorded is taken as the quadriceps peak torque. |
pre (baseline) + post (15weeks)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
6mwt (m)
Časové okno: pre (baseline) - post (15weeks)
|
The 6-minute walk test (6MWT) assesses functional exercise capacity by measuring the distance walked in 6 minutes. It is performed on the same flat, straight corridor (50 meter) with marked turnaround points. The participant is instructed to walk as fast as possible at a self-paced speed. Standardized encouragement is given every minute. A timer is started at the beginning and stopped at 6 minutes. The total distance walked is measured in meters. |
pre (baseline) - post (15weeks)
|
|
Time up and go (s)
Časové okno: pre (baseline) + post (15weeks)
|
The participant starts seated in a standard chair (back against the chair, no armrests) On the command "go," the participant stands up, walks 3 meters, turns around, walks back, and sits down again. Timing starts on "go" and stops when the participant is seated again with the back against the chair). The test is performed 3 times (with 20seconds rest in between). The outcome is the mean time taken to complete the 3 tasks (seconds). |
pre (baseline) + post (15weeks)
|
|
VO2 peak (ml/kg/min)
Časové okno: pre (baseline) + post (15weeks)
|
VO₂peak is measured during a cardiopulmonary exercise test (CPET) on a cycle ergometer. The test is performed on a Lode Corival ergometer with breath-by-breath gas analysis via a Vyaire Medical system. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence(≈60-70 revolutions/min) until volitional exhaustion. Expired gases are analyzed to determine oxygen uptake (VO₂) and carbon dioxide production (VCO₂). Strong verbal encouragement is given to reach maximal effort. VO₂peak is defined as the mean VO₂ value averaged over the final 30 seconds of exercise. Test termination follows symptom limitation or standard clinical safety criteria. |
pre (baseline) + post (15weeks)
|
|
maximal load (Watt)
Časové okno: pre (baseline) + post (15weeks)
|
Wattmax is determined during a CPET performed on a Lode Corival ergometer with monitoring via a Vyaire Medical system. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion. Wattmax is defined as the highest workload (in watts) achieved in the final stage. Strong encouragement is provided to achieve maximal effort. |
pre (baseline) + post (15weeks)
|
|
VO2/W slope (ml/min/W)
Časové okno: pre (baseline) + post (15weeks)
|
VO2/W slope is measured during a cardiopulmonary exercise test (CPET) on a cycle ergometer. The test is performed on a Lode Corival ergometer with breath-by-breath gas analysis via a Vyaire Medical system. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion. The relationship between VO₂ (y-axis) and work rate (x-axis) is plotted. A linear regression is applied. The slope of this line represents the VO₂/W slope (mL/min/W). |
pre (baseline) + post (15weeks)
|
|
VE/VCO2 slope
Časové okno: pre (baseline) + post (15weeks)
|
The VE/VCO₂ slope is measured during CPET on a Lode Corival ergometer with breath-by-breath analysis via Vyaire Medical. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion. VE is plotted against VCO₂ over the course of exercise. A linear regression is applied from the start of exercise up to the ventilatory compensation point. The slope of this relationship represents the VE/VCO₂ slope. |
pre (baseline) + post (15weeks)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- EDGE 002632
- Belgian Heart Fund (Jiné číslo grantu/financování: King Baudouin Foundation)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Efekty silového tréninku
-
Riphah International UniversityDokončeno
-
PepsiCo Global R&DDokončenoDovednostní výkon | Fotbalový výkon | Coffeeberry EffectsSpojené království
-
Methodist Health SystemDokončenoMock Code Training SimulationSpojené státy
-
PepsiCo Global R&DDokončenoDovednostní výkon | Fotbalový výkon | Coffeeberry EffectsSpojené království
-
York St John UniversityYork City Baths ClubAktivní, ne náborPlavání | Protokoly cvičení Power Training | Efekty silového tréninkuSpojené království
-
University of ThessalyUkončenoProtokoly cvičení Power TrainingŘecko
-
The Hong Kong Polytechnic UniversityNáborElektroencefalografie | Transkraniální stimulace stejnosměrným proudem | Porucha autistického spektra | Booster EffectsHongkong
-
Abant Izzet Baysal UniversityNáborParkinsonova choroba | Virtuální realita | Pohlcující virtuální realita | Akce Obervation Training | 3D nahráváníTurecko (Türkiye)
Klinické studie na eccentric bike training
-
Trinitas Comprehensive Cancer CenterAptium Oncology Research NetworkNeznámýRakovina prsuSpojené státy
-
Florida State UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH)Dokončeno
-
University of CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development...DokončenoCévní mozková příhoda, ischemická | Dysfagie, orální fázeSpojené státy
-
University Hospital, Basel, SwitzerlandDokončenoVývoj dítěte | Studie proveditelnosti | Primární zdravotní péče | Svalová síla | Odporový trénink | Školy | Preventivní zdravotní služby | Školy / organizace a správaŠvýcarsko
-
Bayburt UniversityZatím nenabírámeStrach z porodu | Všímavost | Self-Efficacy | Příloha | Haptonomie
-
Selcan SuicmezDokončeno
-
University of FloridaDepartment of Health and Human Services; Georgia State UniversityDokončenoDeprese | Kvalita života | Duševní zdraví | Starší dospělí | Osamělost | Riziko sebevraždy | Společenská izolace | Chování při hledání pomoci | Sociální fungování | Zmařená sounáležitost | Vnímaná zátěž | Sebevražedné myšlenkySpojené státy
-
Northwestern UniversityNáborObstrukční spánková apnoe (OSA)Spojené státy
-
Inés Llamas-RamosNáborRoztroušená skleróza | Svalová slabost | Tréninková skupina, CitlivostŠpanělsko