- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01518114
Exercise Training in Patients With Hypertrophic Cardiomyopathy
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tel Hashomer , Ramat Gan, Israël
- Werving
- Sheba Medical Center
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Contact:
- Robert Klempfner, MD
- Telefoonnummer: +972525506852
- E-mail: klempfner@gmail.com
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Hoofdonderzoeker:
- Arad Michael, MD
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Onderonderzoeker:
- Tamir Kamerman, MS
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Hypertrophic Cardiomyopathy
- NYHA 3
- Maximal left ventricular wall thickness > 20 mm
- Age >18
Exclusion Criteria:
- Severe non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.
- Patients state post resuscitation for malignant ventricular arrhythmia.
- History of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.
- An exercise-induced decrease in blood pressure
- Severe left ventricular outflow obstruction defined as resting outflow gradient > 50 mmHg on maximal therapy
- Atrial fibrillation with a poorly controlled ventricular response
- Advanced hypokinetic stage of HCM defined as LVEF < 40%
- Congestive heart failure of angina FC IV according to NYHA or CCS respectively.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Exercise Training
Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale. Exercise prescription will be based upon cardiopulmonary test done at baseline. |
Exercise will be performed under continuous telemetry monitoring and medical supervision.
Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise.
Blood pressure will be obtained before the onset and at the end of each session.
Participants will be requested to rest and observed 15-30 min before going home.
The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
|
Actieve vergelijker: Best Medical Care
Advanced HCM patients who are eligible to participate in the study but cannot do so for technical reasons will be invited to participate in the project as a control group.These subjects will continue their regular follow up in the Cardiomyopathy Clinic and their usual voluntary physical activity at home.
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Exercise will be performed under continuous telemetry monitoring and medical supervision.
Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise.
Blood pressure will be obtained before the onset and at the end of each session.
Participants will be requested to rest and observed 15-30 min before going home.
The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
Tijdsspanne: 6 months
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End point to be assessed by cardiopulmonary testing are pre- and post exercise training improvement as expressed by the changes in : VO2 MAX, exercise duration, duration to ventilatory threshold(VT).
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6 months
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Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy
Tijdsspanne: 12 months
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Safety endpoonts: 1) Clinicaly significant arrhythmia during exercise training 2)MACE during follow-up period (ACS, Stroke or Death) 3)Exercise Related Injury 4) Episodes of syncope
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Secondary Endpoints:
Tijdsspanne: 12 months
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12 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SHEBA-10-8081-MA-CTIL
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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