Cardiovascular DiseasePhase 2ACE-REHABNCT02845063
Effect of ACE Genotype on Cardiovascular Rehabilitation
A Phase 2 study testing concentric cardiovascular training, eccentric cardiovascular training and ACE genotyping in people with Cardiovascular Disease, run by Balgrist University Hospital at 2 sites in Switzerland.
Trial summary
The study aims to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- concentric cardiovascular training, eccentric cardiovascular training and ACE genotyping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 May 2016to 1 Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 27Show fewer
- 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])
- Healthy subject group inclusion criteria:
- 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
- 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])
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Balgrist University Hospital
Zurich, 8008
University Hospital Zurich
Zurich, 8091
About this study
Official title: Effects of ACE Genotype on Muscular and Functional Adaptations Following a Cardiovascular Rehabilitation Program
The study aims to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program. This is carried out with the goal to improve the benefit of cardiovascular rehabilitation for the patient by maximising adjustments in muscle structure and function with the intervention. A population of healthy individuals will be recruited who will carry out the same training program, in order to compare the training effects respective to the general population.
Read the detailed description
Pharmacological inhibition of angiotensin converting enzyme modifies exercise-induced pro-angiogenic and mitochondrial gene transcript expression. Exercise-induced muscle plasticity importantly interacts with the insertion/deletion genotype of ACE and the training modality and intensity. The aim of this study is to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program.
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
- Cardiovascular Disease
- Being tested
- concentric cardiovascular training, eccentric cardiovascular training, ACE genotyping
- Keywords
- muscle plasticity, exercise, rehabilitation, perfusion, ACE, genotype, hypertension, molecular biology
- Medical subject headings
- Cardiovascular Diseases, Motor Activity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentric cardiovascular trainingBehavioural
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 trainingBehavioural
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 genotypingGenetic
Subjects will be genotyped for the ACE-I/D gene polymorphism.
| Study group | Role | What they receive |
|---|---|---|
| concentric cardiovascular rehabilitation | Experimental | Heart patients under ACE inhibitor intake will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' Receives: Behavioral: concentric cardiovascular training; Genetic: ACE genotyping |
| eccentric cardiovascular rehabilitation | Experimental | Heart patients under ACE inhibitor intake will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' Receives: Behavioral: eccentric cardiovascular training; Genetic: ACE genotyping |
| concentric cardiovascular training | Active comparator | Healthy subjects will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' Receives: Behavioral: concentric cardiovascular training; Genetic: ACE genotyping |
| eccentric cardiovascular training | Active comparator | Healthy subjects will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' Receives: Behavioral: eccentric cardiovascular training; Genetic: ACE genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACE I/D genotype
Genotype of the assessed insertion/deletion gene polymorphism of angiotensin converting enzyme ACE, i.e. ACE-II, ACE-ID or ACE-DD.
Measured: 975 days: May 2016-January 2019
Molecular muscle characteristics - mRNA
- mRNA expression of VEGF, HIF-1a, HIF-1b, tenascin-C, Angpt1, Angpt1R, neuropilin, midkine, restin, COX4-1, COX4I-2, CPTI, LPL, LIPE, FATP, CD36 [relative expression per 28S rRNA]
Measured: 975 days: May 2016-January 2019
Molecular muscle characteristics- protein
- Protein content of FAK, FRNK, p70S6K, mTOR, JNK, NDUFA9, SDH, UQCRC1, COX4I1, COX4I2, ATP5A1, VEGF, HIF-1a, CD31, MHC-1, MHC-2A, MHC-2X, MyoD, myogenin, CaMKII [pixel counts per actin]
Measured: 975 days: May 2016-January 2019
Molecular muscle characteristics- phosphorylation
- Phosphorylation of proteins phospho-Y397- FAK, phospho-T421/S424-P70S6K, phospho -T183/Y185-JNK, phospho-S2448-mTOR [pixel counts per actin]
Measured: 975 days: May 2016-January 2019
Molecular muscle characteristics- ACE
- ACE activity [fmol min-1]
Measured: 975 days: May 2016-January 2019
Cellular muscle characteristics - fiber type %
- Distribution of type I, IIA and IIX fibers [%]
Measured: 975 days: May 2016-January 2019
Cellular muscle characteristics - fiber area %
- Area percentage of type I, IIA and IIX fibers [% area]
Measured: 975 days: May 2016-January 2019
Cellular muscle characteristics - fiber type CSA
- Cross sectional area of type I, IIA and IIX fibers [micrometer2]
Measured: 975 days: May 2016-January 2019
Cellular muscle characteristics - Capillary density
- Capillary density [capillaries micrometer-2]
Measured: 975 days: May 2016-January 2019
Cellular muscle characteristics - Capillary-to-fiber ratio
- Capillary-to-fiber ratio
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Maximal Power
- Maximal power during ramp test on ergometer [Watt]
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Critical Power
- Critical power in ramp test on ergometer [Watt]
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Real Power
- Real Power as estimated on the soft robotic device [Watt]
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Reactive Power
- Reactive Power as estimated on the soft robotic device [Watt]
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Negative Power
- Negative Power as estimated on the soft robotic device [Watt]
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Maximal force
- Maximal force during the reactive power test on the soft robotic device [Newton]
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Maximal velocity
- Maximal velocity during the reactive power test on the soft robotic device [m sec-1]
Measured: 975 days: May 2016-January 2019
Functional muscle characteristics - Rate of force development
- Rate of force development as estimated during the Real Power test on the soft robotic device [meter sec-2]
Measured: 975 days: May 2016-January 2019
Muscle metabolism - muscle oxygenation ramp
- Muscle oxygenation (m. vastus lateralis, m. gastrocnemius, m. gluteus maximus) during ramp test on ergometer [%]
Measured: 975 days: May 2016-January 2019
Muscle metabolism - muscle oxygenation robot exercise
- Muscle oxygenation (m. vastus lateralis, m. gastrocnemius, m. gluteus maximus) during exercise on soft robot [%]
Measured: 975 days: May 2016-January 2019
Muscle metabolism - hemoglobin ramp
- Total hemoglobin during ramp test on ergometer [%]
Measured: 975 days: May 2016-January 2019
Muscle metabolism - hemoglobin robot exercise
- Total hemoglobin during exercise on soft robot [%]
Measured: 975 days: May 2016-January 2019
Muscle metabolism - lipid compounds
- Concentration of lipid compounds in m. vastus lateralis muscle during exercise on soft roboter
Measured: 975 days: May 2016-January 2019
Muscle metabolism - metabolites
- Concentration of metabolites in m. vastus lateralis muscle during exercise on soft roboter
Measured: 975 days: May 2016-January 2019
Muscle metabolism - serum glucose
- Concentration of glucose in serum during ramp test on ergometer [mmol l-1]
Measured: 975 days: May 2016-January 2019
Muscle metabolism - serum lactate
- Concentration of lactate in serum during ramp test on ergometer [mmol l-1]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - Heart rate rest
- Heart rate at rest [beats per minute]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - Heart rate ramp
- Heart rate in ramp test on ergometer [beats per minute]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - cardiac output
- Cardiac output [L min-1]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - ejection fraction
- Ejection fraction
Measured: 975 days: May 2016-January 2019
Cardiovascular function - Maximal oxygen uptake
- Maximal oxygen uptake (VO2max) during ramp test on ergometer [ml O2 min-1 kg-1]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - ventilation
- Ventilation during ramp test on ergometer [L min-1]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - ventilation frequency
- Ventilation frequency ramp test on ergometer [min-1]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - respiration quotient
- Respiration quotient during ramp test on ergometer [ L O2 inspired / L CO2 expired]
Measured: 975 days: May 2016-January 2019
Cardiovascular function - endurance
Time-to-exhaustion in constant load on ergometer [seconds]
Measured: 975 days: May 2016-January 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start1 May 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
Why it stopped: Study terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Walter O Frey, MD, Principal investigator, Balgrist University Hospital, Move>med, Swiss Olympic Center, Zurich, SwitzerlandChristian M Schmied, MD, Principal investigator, Cardiology, University Hospital Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845063
- Sponsor's protocol ID
- W 549 ACE-REHAB
- Other IDs
- KEK-ZH-Nr. 2014-0319
- Acronym
- ACE-REHAB
- Status last verified
- Aug 2023
- First submitted
- 27 Nov 2015
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26407530van 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.
PubMed 25262765Mathes 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.
PubMed 26937347Vaughan 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.
PubMed 23397151Fitze 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.
PubMed 30916659
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ACE Genotype on Muscular and Functional Adaptations Following a Cardiovascular Rehabilitation Program
- ClinicalTrials.gov ID
- NCT02845063
- Acronym / sponsor ID
- ACE-REHAB / W 549 ACE-REHAB
- Conditions
- Cardiovascular Disease
- Keywords
- muscle plasticity, exercise, rehabilitation, perfusion, ACE, genotype, hypertension, molecular biology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program. This is carried out with the goal to improve the benefit of cardiovascular rehabilitation for the patient by maximising adjustments in muscle structure and function with the intervention. A population of healthy individuals will be recruited who will carry out the same training program, in order to compare the training effects respective to the general population.
Detailed description
Pharmacological inhibition of angiotensin converting enzyme modifies exercise-induced pro-angiogenic and mitochondrial gene transcript expression. Exercise-induced muscle plasticity importantly interacts with the insertion/deletion genotype of ACE and the training modality and intensity. The aim of this study is to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| concentric cardiovascular rehabilitation | Experimental | Behavioral: concentric cardiovascular training, Genetic: ACE genotypingHeart patients under ACE inhibitor intake will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' |
| eccentric cardiovascular rehabilitation | Experimental | Behavioral: eccentric cardiovascular training, Genetic: ACE genotypingHeart patients under ACE inhibitor intake will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' |
| concentric cardiovascular training | Active comparator | Behavioral: concentric cardiovascular training, Genetic: ACE genotypingHealthy subjects will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' |
| eccentric cardiovascular training | Active comparator | Behavioral: eccentric cardiovascular training, Genetic: ACE genotypingHealthy subjects will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping' |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (27 listed)
- relevant valvular heart disease
- arterial hypertension (blood pressure at rest> 140/90)
- arrhythmogenic cardiomyopathy
- ACE inhibitor intolerance
- contraindication for ethical reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| concentric cardiovascular trainingSubjects 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. | Behavioural | concentric cardiovascular rehabilitation, concentric cardiovascular training |
| eccentric cardiovascular trainingSubjects 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. | Behavioural | eccentric cardiovascular rehabilitation, eccentric cardiovascular training |
| ACE genotypingSubjects will be genotyped for the ACE-I/D gene polymorphism. | Genetic | concentric cardiovascular rehabilitation, concentric cardiovascular training, eccentric cardiovascular rehabilitation, eccentric cardiovascular training |
Primary outcome
ACE I/D genotype
Time frame: 975 days: May 2016-January 2019
Genotype of the assessed insertion/deletion gene polymorphism of angiotensin converting enzyme ACE, i.e. ACE-II, ACE-ID or ACE-DD.
Molecular muscle characteristics - mRNA
Time frame: 975 days: May 2016-January 2019
• mRNA expression of VEGF, HIF-1a, HIF-1b, tenascin-C, Angpt1, Angpt1R, neuropilin, midkine, restin, COX4-1, COX4I-2, CPTI, LPL, LIPE, FATP, CD36 [relative expression per 28S rRNA]
Molecular muscle characteristics- protein
Time frame: 975 days: May 2016-January 2019
• Protein content of FAK, FRNK, p70S6K, mTOR, JNK, NDUFA9, SDH, UQCRC1, COX4I1, COX4I2, ATP5A1, VEGF, HIF-1a, CD31, MHC-1, MHC-2A, MHC-2X, MyoD, myogenin, CaMKII [pixel counts per actin]
Molecular muscle characteristics- phosphorylation
Time frame: 975 days: May 2016-January 2019
• Phosphorylation of proteins phospho-Y397- FAK, phospho-T421/S424-P70S6K, phospho -T183/Y185-JNK, phospho-S2448-mTOR [pixel counts per actin]
Molecular muscle characteristics- ACE
Time frame: 975 days: May 2016-January 2019
• ACE activity [fmol min-1]
Cellular muscle characteristics - fiber type %
Time frame: 975 days: May 2016-January 2019
• Distribution of type I, IIA and IIX fibers [%]
Cellular muscle characteristics - fiber area %
Time frame: 975 days: May 2016-January 2019
• Area percentage of type I, IIA and IIX fibers [% area]
Cellular muscle characteristics - fiber type CSA
Time frame: 975 days: May 2016-January 2019
• Cross sectional area of type I, IIA and IIX fibers [micrometer2]
Cellular muscle characteristics - Capillary density
Time frame: 975 days: May 2016-January 2019
• Capillary density [capillaries micrometer-2]
Cellular muscle characteristics - Capillary-to-fiber ratio
Time frame: 975 days: May 2016-January 2019
• Capillary-to-fiber ratio
Functional muscle characteristics - Maximal Power
Time frame: 975 days: May 2016-January 2019
• Maximal power during ramp test on ergometer [Watt]
Functional muscle characteristics - Critical Power
Time frame: 975 days: May 2016-January 2019
• Critical power in ramp test on ergometer [Watt]
Functional muscle characteristics - Real Power
Time frame: 975 days: May 2016-January 2019
• Real Power as estimated on the soft robotic device [Watt]
Functional muscle characteristics - Reactive Power
Time frame: 975 days: May 2016-January 2019
• Reactive Power as estimated on the soft robotic device [Watt]
Functional muscle characteristics - Negative Power
Time frame: 975 days: May 2016-January 2019
• Negative Power as estimated on the soft robotic device [Watt]
Functional muscle characteristics - Maximal force
Time frame: 975 days: May 2016-January 2019
• Maximal force during the reactive power test on the soft robotic device [Newton]
Functional muscle characteristics - Maximal velocity
Time frame: 975 days: May 2016-January 2019
• Maximal velocity during the reactive power test on the soft robotic device [m sec-1]
Functional muscle characteristics - Rate of force development
Time frame: 975 days: May 2016-January 2019
• Rate of force development as estimated during the Real Power test on the soft robotic device [meter sec-2]
Muscle metabolism - muscle oxygenation ramp
Time frame: 975 days: May 2016-January 2019
• Muscle oxygenation (m. vastus lateralis, m. gastrocnemius, m. gluteus maximus) during ramp test on ergometer [%]
Muscle metabolism - muscle oxygenation robot exercise
Time frame: 975 days: May 2016-January 2019
• Muscle oxygenation (m. vastus lateralis, m. gastrocnemius, m. gluteus maximus) during exercise on soft robot [%]
Muscle metabolism - hemoglobin ramp
Time frame: 975 days: May 2016-January 2019
• Total hemoglobin during ramp test on ergometer [%]
Muscle metabolism - hemoglobin robot exercise
Time frame: 975 days: May 2016-January 2019
• Total hemoglobin during exercise on soft robot [%]
Muscle metabolism - lipid compounds
Time frame: 975 days: May 2016-January 2019
• Concentration of lipid compounds in m. vastus lateralis muscle during exercise on soft roboter
Muscle metabolism - metabolites
Time frame: 975 days: May 2016-January 2019
• Concentration of metabolites in m. vastus lateralis muscle during exercise on soft roboter
Muscle metabolism - serum glucose
Time frame: 975 days: May 2016-January 2019
• Concentration of glucose in serum during ramp test on ergometer [mmol l-1]
Muscle metabolism - serum lactate
Time frame: 975 days: May 2016-January 2019
• Concentration of lactate in serum during ramp test on ergometer [mmol l-1]
Cardiovascular function - Heart rate rest
Time frame: 975 days: May 2016-January 2019
• Heart rate at rest [beats per minute]
Cardiovascular function - Heart rate ramp
Time frame: 975 days: May 2016-January 2019
• Heart rate in ramp test on ergometer [beats per minute]
Cardiovascular function - cardiac output
Time frame: 975 days: May 2016-January 2019
• Cardiac output [L min-1]
Cardiovascular function - ejection fraction
Time frame: 975 days: May 2016-January 2019
• Ejection fraction
Cardiovascular function - Maximal oxygen uptake
Time frame: 975 days: May 2016-January 2019
• Maximal oxygen uptake (VO2max) during ramp test on ergometer [ml O2 min-1 kg-1]
Cardiovascular function - ventilation
Time frame: 975 days: May 2016-January 2019
• Ventilation during ramp test on ergometer [L min-1]
Cardiovascular function - ventilation frequency
Time frame: 975 days: May 2016-January 2019
• Ventilation frequency ramp test on ergometer [min-1]
Cardiovascular function - respiration quotient
Time frame: 975 days: May 2016-January 2019
• Respiration quotient during ramp test on ergometer [ L O2 inspired / L CO2 expired]
Cardiovascular function - endurance
Time frame: 975 days: May 2016-January 2019
Time-to-exhaustion in constant load on ergometer [seconds]
Results and safety
The study was stopped early (reason given: Study terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 26407530van 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.
- Background: PubMed 25262765van 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.
- BackgroundMathes 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.
- Background: PubMed 26937347van 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.
- Background: PubMed 23397151Vaughan 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.
- Derived from this study: PubMed 30916659Fitze 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.
- Mathes et al, 2015Link provided by the sponsor.
- van Ginkel et al, 2015Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter O Frey, MD principal investigator
Balgrist University Hospital, Move>med, Swiss Olympic Center, Zurich, Switzerland
Christian M Schmied, MD principal investigator
Cardiology, University Hospital Zurich, Zurich, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing concentric cardiovascular training, eccentric cardiovascular training and ACE genotyping in people with Cardiovascular Disease, run by Balgrist University Hospital at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACE I/D genotype (time frame: 975 days: May 2016-January 2019). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02845063, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.