- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05185895
Visa-versa! Breaking Instead of Pushing the Pedals-D
Visa-versa! Breaking Instead of Pushing the Pedals: Eccentric Exercise to Improve Training Performance in Healthy Controls. A Single-center Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eccentric muscle work is when a muscle lengthens while applying force. Although eccentric muscle work is part of everyday life, e.g. whilst descending, it is not integrated in modern training protocols and its underlying physiological mechanisms are still incompletely understood. It was shown that muscles are able to perform four times as much power eccentrically compared to common concentric muscle work with a comparably very low oxygen demand and thus cardiovascular load. Thus, eccentric training may be of special interest for patients with cardiopulmonary diseases. Since much higher training intensities are achieved eccentrically, the training increase after a few weeks of eccentric training is huge compared to ordinary concentric training. In addition, it has been observed that these high intensities applied eccentrically lead also to a concentric gain in strength and are therefore transferable to everyday activities. Physical training has been shown to be beneficial in almost every cardiovascular disease, even in severely limited patients. However, training intensities may be very low in some patients with advanced cardiopulmonary disease, so some patients are physically almost unable to perform exercise on a beneficial level. Thus, for this collective, eccentric training may to be a very intriguing option. Patients with pulmonary vascular diseases such as pulmonary arterial and chronic thromboembolic pulmonary hypertension (PH) per definition reveal an elevated pulmonary artery pressure (PAP) along with an increased pulmonary vascular resistance (PVR). However, also other common diseases, such as left heart disease (LHD) or chronic obstructive pulmonary disease (COPD) are often associated with PH. The cardinal symptoms of PH is dyspnea on exertion leading to limited exercise performance, daily activity and quality of life. PH-patients also benefit from structured exercise training, but training intensities might be limited in patients with advanced disease. A few studies have investigated eccentric exercising in cardiopulmonary patients but none in PH. Most of these studies are in patients with coronary heart disease- (CHD) or COPD, including only few participants and often studies did not followed sound methodologies, such as randomized-controlled trial (RCT) protocols However, even in the hitherto limited patients´ investigated, eccentric training was assessed beneficial, feasible and safe.
The physiological cardiopulmonary response to eccentric exercising has not been investigated in patients with PH and the physiological basis to investigate such training opportunities is completely lacking.
The aim of this project is to investigate the cardiopulmonary effects of eccentric exercise in using solid randomized-controlled research protocols in cardiopulmonary diseases with focus on PH in order to provide a basis to the question of whether this promising training method could become established in cardiopulmonary rehabilitation, especially in patients with advanced disease and pulmonary hypertension.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- Respiratory Clinic, University Hospital of Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed informed consent.
- no cardio respiratory diseases
Exclusion Criteria:
- Severe daytime hypoxemia (pO2 ≤7.3 kPa or <55 mmHg).
- Other clinically significant concomitant disease states (e.g., renal, hepatic dysfunction, etc.).
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorder, dementia or confusional state of the subject, neurological or orthopedic problems with inability to ride a bicycle.
- Woman with known pregnancy (Women with known pregnancy will not be allowed into the study. It will however not be searched for early unknown pregnancy in woman of child-bearing potential, as cycling is not contraindicated in early unknown pregnancy stage and we thus do not plan routine pregnancy tests before study entrance in women of childbearing potential).
- Enrolment into another clinical trial with active treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Start with: Concentric (normal) cycling
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The exposure to eccentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
The exposure to concentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
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Experimental: Start with: Eccentric cycling
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The exposure to eccentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
The exposure to concentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen uptake (peak VO2 [l/min])
Time Frame: 1 Day
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Difference in oxygen uptake (peak VO2 [l/min]) of eccentric vs. concentric cycling exercise.
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1 Day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory exchange ratio (RER)
Time Frame: 1 day
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Volume carbon dioxide devided by the volume of oxygen( VCO2/VO2)
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1 day
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Breathing equivalent for carbon dioxide
Time Frame: 1 day
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Minute ventilation divided by volume carbon dioxide (VE/VCO2)
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1 day
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Pulmonary end tidal carbon dioxide (PET CO2)
Time Frame: 1 day
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The level of carbon dioxide that is released at the end of an exhaled breath
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1 day
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Arterial oxygen saturation (SpO2)
Time Frame: 1 day
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Noninvasively measured oxygenation of the hemoglobin by pulse oximetry (Light Sensors)
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1 day
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Borg Scale for dyspnea
Time Frame: 1 day
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Patient reported level of dyspnea from 0 to 10 while 10 is the worst
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1 day
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Borg Scale for leg fatigue
Time Frame: 1 day
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Patient reported level of leg fatigue from 0 to 10 while 10 is the worst
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1 day
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Cardiac output
Time Frame: 1 day
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How many liters blood is the heart able to move in one minute.
Assessed by echocardiography.
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1 day
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Pulmonary Artery Pressure
Time Frame: 1 day
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Right ventricle pressure divided by the right atrium pressure gradient (RV/RA pressure gradient) to assess the systolic pulmonary artery pressure by echocardiography
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1 day
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Blood pressure
Time Frame: 1 day
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Systolic and diastolic blood pressure assessed by arm cuff measurement
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1 day
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Brain tissue oxygenation
Time Frame: 1 day
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Oxygenation of the brain tissue assessed by light sensors on the forehead
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1 day
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Muscle tissue oxygenation
Time Frame: 1 day
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Oxygenation of the muscle tissue assessed by light sensors on the quadriceps muscle
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1 day
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Arterial blood gases: PH
Time Frame: 1 day
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Arterial blood gases: PH, assessed by arterial blood sample
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1 day
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Arterial blood gases: Partialpressure for oxygen (PaO2)
Time Frame: 1 day
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Arterial blood gases: Partialpressure for oxygen (PaO2), assessed by arterial blood sample
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1 day
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Arterial blood gases: Bicarbonate (HCO3)
Time Frame: 1 day
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Arterial blood gases: Bicarbonate (HCO3), assessed by arterial blood sample
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1 day
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Arterial blood gases: lactate
Time Frame: 1 day
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Arterial blood gases: lactate, assessed by arterial blood sample
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1 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Visa-Versa!-D
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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