Effect of ACE Genotype on Cardiovascular Rehabilitation
NCT ID: NCT02845063
Last Updated: 2023-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
60 participants
INTERVENTIONAL
2016-05-01
2020-01-01
Brief Summary
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Detailed Description
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There are two training modalities being used: The first modality involves cardiovascular training by an interval type of protocol that includes a high repetition number of shortening (i.e. concentric) type contractions on a softrobotic device. The second modality includes a high repetition number of lengthening (i.e. eccentric) type contractions on a softrobotic device. In both training modalities the same muscle groups are exercised over the same range of motion, with the same speed of movement, but with widely differing pedal force. Total absolute external mechanical work will be matched.
In order to assess the baseline values and the effect size of the muscle and training adjustments made, healthy male and female volunteers will be included who are matched with respect to age and sex to the patient population and undergo the same training program.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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concentric cardiovascular rehabilitation
Heart patients under ACE inhibitor intake will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'
concentric cardiovascular training
Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of concentric type contractions on a softrobotic device.
ACE genotyping
Subjects will be genotyped for the ACE-I/D gene polymorphism.
eccentric cardiovascular rehabilitation
Heart patients under ACE inhibitor intake will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'
eccentric cardiovascular training
Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of eccentric type contractions on a softrobotic device.
ACE genotyping
Subjects will be genotyped for the ACE-I/D gene polymorphism.
concentric cardiovascular training
Healthy subjects will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'
concentric cardiovascular training
Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of concentric type contractions on a softrobotic device.
ACE genotyping
Subjects will be genotyped for the ACE-I/D gene polymorphism.
eccentric cardiovascular training
Healthy subjects will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'
eccentric cardiovascular training
Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of eccentric type contractions on a softrobotic device.
ACE genotyping
Subjects will be genotyped for the ACE-I/D gene polymorphism.
Interventions
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concentric cardiovascular training
Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of concentric type contractions on a softrobotic device.
eccentric cardiovascular training
Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of eccentric type contractions on a softrobotic device.
ACE genotyping
Subjects will be genotyped for the ACE-I/D gene polymorphism.
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction \> 50%
* Drug therapy with ACE inhibitors
* V̇O2peak \<86% of the medical reference value Voluntary participation
* Written informed consent of the subject to participate in the study
* inconspicuous ECG under exercise (persons in whom the exercise ECG is abnormal will be referred for a cardiological evaluation recessed to the University Hospital Zurich)
* V̇O2peak \<50 ml O2 min-1 kg-1
* Voluntary participation
* Written informed consent of the subject to participate in the study
Exclusion Criteria
* arterial hypertension (blood pressure at rest\> 140/90)
* arrhythmogenic cardiomyopathy
* ACE inhibitor intolerance
* contraindication for ethical reasons
* known or suspected non-compliance with the curriculum
* smoker
* drug or alcohol disease
* inability of the patient to follow the study procedures (e.g. because of language problems, mental illness, dementia)
* participation in another clinical trial within the last 30 days prior to confinement and during the study
* other, clinically significant comorbidities (cardiac arrhythmia, renal insufficiency, hepatic dysfunction, connective tissue disease \[Marfan syndrome, Ehlers-Danlos syndrome\])
* relevant valvular heart disease
* arterial hypertension (blood pressure at rest\> 140/90)
* arrhythmogenic cardiomyopathy
* ACE inhibitor intolerance
* contraindication for ethical reasons
* known or suspected non-compliance with the curriculum
* smoker
* drug or alcohol disease
* inability of the patient to follow the study procedures (e.g. because of language problems, mental illness, dementia)
* participation in another clinical trial within the last 30 days prior to confinement and during the study
* other, clinically significant comorbidities (cardiac arrhythmia, renal insufficiency, hepatic dysfunction, connective tissue disease \[Marfan syndrome, Ehlers-Danlos syndrome\])
20 Years
65 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Balgrist University Hospital
OTHER
Responsible Party
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Principal Investigators
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Walter O Frey, MD
Role: PRINCIPAL_INVESTIGATOR
Balgrist University Hospital, Move>med, Swiss Olympic Center, Zurich, Switzerland
Christian M Schmied, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiology, University Hospital Zurich, Zurich, Switzerland
Locations
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Balgrist University Hospital
Zurich, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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van Ginkel S, Ruoss S, Valdivieso P, Degens H, Waldron S, de Haan A, Fluck M. ACE inhibition modifies exercise-induced pro-angiogenic and mitochondrial gene transcript expression. Scand J Med Sci Sports. 2016 Oct;26(10):1180-7. doi: 10.1111/sms.12572. Epub 2015 Sep 26.
van Ginkel S, Amami M, Dela F, Niederseer D, Narici MV, Niebauer J, Scheiber P, Muller E, Fluck M. Adjustments of muscle capillarity but not mitochondrial protein with skiing in the elderly. Scand J Med Sci Sports. 2015 Aug;25(4):e360-7. doi: 10.1111/sms.12324. Epub 2014 Sep 28.
Mathes S, van Ginkel SL, Vaughan D, Valdivieso P, Flück M, Gene-pharmacologial effects on exercise-induced muscle gene expression in healthy men. Anat Physiol 2015, S5.
van Ginkel S, de Haan A, Woerdeman J, Vanhees L, Serne E, de Koning J, Fluck M. Exercise intensity modulates capillary perfusion in correspondence with ACE I/D modulated serum angiotensin II levels. Appl Transl Genom. 2015 Mar 27;4:33-7. doi: 10.1016/j.atg.2015.03.002. eCollection 2015 Mar.
Vaughan D, Huber-Abel FA, Graber F, Hoppeler H, Fluck M. The angiotensin converting enzyme insertion/deletion polymorphism alters the response of muscle energy supply lines to exercise. Eur J Appl Physiol. 2013 Jul;113(7):1719-29. doi: 10.1007/s00421-012-2583-6. Epub 2013 Feb 9.
Fitze DP, Franchi M, Popp WL, Ruoss S, Catuogno S, Camenisch K, Lehmann D, Schmied CM, Niederseer D, Frey WO, Fluck M. Concentric and Eccentric Pedaling-Type Interval Exercise on a Soft Robot for Stable Coronary Artery Disease Patients: Toward a Personalized Protocol. JMIR Res Protoc. 2019 Mar 27;8(3):e10970. doi: 10.2196/10970.
Related Links
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van Ginkel et al, 2015
Other Identifiers
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KEK-ZH-Nr. 2014-0319
Identifier Type: OTHER
Identifier Source: secondary_id
W 549 ACE-REHAB
Identifier Type: -
Identifier Source: org_study_id
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