Pulmonary HypertensionNCT05186987
Visa-versa! Breaking Instead of Pushing the Pedals-A
A study testing 15 minutes eccentric cycling and 15 minutes concentric (normal) cycling in people with Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
Eccentric muscle work is defined as lengthening of a muscle while applying force. It was shown that with eccentric work, muscles are able to perform four times as much power compared to usual concentric work, which results in huge training gain with a highly decreased oxygen demand and thus lower cardiovascular load. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- 15 minutes eccentric cycling and 15 minutes concentric (normal) cycling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2022to 30 Sep 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in a stable condition on the same disease specific medication >4 weeks.
- Signed informed consent.
- Precapillary pulmonary hypertension (PH) diagnosed according to international guidelines: mean pulmonary artery pressure (mPAP) ≥25 mmHg and pulmonary artery wedge pressure (PAWP) ≤15 mmHg, pulmonary vascular resistance >2 WU, measured by right heart catherization and clinically diagnosed as Pulmonary arterial and chronic thromboembolic pulmonary hypertension, class 1 or class 4
Who cannot join
- 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.
- Enrolment into another clinical trial with active treatment.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Visa-versa! Breaking Instead of Pushing the Pedals: Eccentric Exercise to Improve Training Performance in Patients With Pulmonary Hypertension. A Single-center Randomized Controlled Trial
Eccentric muscle work is defined as lengthening of a muscle while applying force. It was shown that with eccentric work, muscles are able to perform four times as much power compared to usual concentric work, which results in huge training gain with a highly decreased oxygen demand and thus lower cardiovascular load. Pulmonary hypertension (PH) is a chronic condition associated with significant reduced exercise capacity and increased morbidity and mortality, resulting in reduced quality of life. Physical training has been shown to be beneficial in PH, even in severely limited patients. However, due to cardiopulmonary constraints in PH, training intensities may be very low, so that many patients are physically almost unable to perform exercise on a high enough level to maintain muscle mass. A low body muscle not only feeds the vicious cycle of decreasing exercise capacity, but also has many deleterious metabolic and immunological consequences which further increase disability and decrease quality of life in PH. Thus, eccentric training, which allows to gain muscle mass with a low stress to the cardiopulmonary unit may to be highly beneficial for patients with PH and allied cardiopulmonary disease, such as chronic obstructive pulmonary disease (COPD) and heart failure. Therefore, the objective of the trial is, to compare differences in oxygen uptake (peak VO2 [l/min]) and other physiological measures during similar cardiopulmonary exercise test protocols of eccentric- vs. concentric cycling in PH- patients and comparators with or without other cardiopulmonary diseases.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- 15 minutes eccentric cycling, 15 minutes concentric (normal) cycling
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 minutes eccentric cyclingProcedure or surgery
The exposure to eccentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
15 minutes concentric (normal) cyclingProcedure or surgery
The exposure to concentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Start with: Concentric (normal) cycling | Sham comparator | Not described Receives: Procedure: 15 minutes eccentric cycling; Procedure: 15 minutes concentric (normal) cycling |
| Start with: Eccentric cycling | Experimental | Not described Receives: Procedure: 15 minutes eccentric cycling; Procedure: 15 minutes concentric (normal) cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake (peak VO2 [l/min])
Difference in oxygen uptake (peak VO2 [l/min]) of eccentric vs. concentric cycling exercise.
Measured: 1 Day
Secondary outcomes (15)
Respiratory exchange ratio (RER)
Volume carbon dioxide devided by the volume of oxygen( VCO2/VO2)
Measured: 1 day
Breathing equivalent for carbon dioxide
Minute ventilation divided by volume carbon dioxide (VE/VCO2)
Measured: 1 day
Pulmonary end tidal carbon dioxide (PET CO2)
The level of carbon dioxide that is released at the end of an exhaled breath
Measured: 1 day
Arterial oxygen saturation (SpO2)
Noninvasively measured oxygenation of the hemoglobin by pulse oximetry (Light Sensors)
Measured: 1 day
Borg Scale for dyspnea
Patient reported level of dyspnea from 0 to 10 while 10 is the worst
Measured: 1 day
Borg Scale for leg fatigue
Patient reported level of leg fatigue from 0 to 10 while 10 is the worst
Measured: 1 day
Cardiac output
How many liters blood is the heart able to move in one minute. Assessed by echocardiography.
Measured: 1 day
Pulmonary Artery Pressure
Right ventricle pressure divided by the right atrium pressure gradient (RV/RA pressure gradient) to assess the systolic pulmonary artery pressure by echocardiography
Measured: 1 day
Blood pressure
Systolic and diastolic blood pressure assessed by arm cuff measurement
Measured: 1 day
Brain tissue oxygenation
Oxygenation of the brain tissue assessed by light sensors on the forehead
Measured: 1 day
Muscle tissue oxygenation
Oxygenation of the muscle tissue assessed by light sensors on the quadriceps muscle
Measured: 1 day
Arterial blood gases: PH
Arterial blood gases: PH, assessed by arterial blood sample
Measured: 1 day
Arterial blood gases: Partialpressure for oxygen (PaO2)
Arterial blood gases: Partialpressure for oxygen (PaO2), assessed by arterial blood sample
Measured: 1 day
Arterial blood gases: Bicarbonate (HCO3)
Arterial blood gases: Bicarbonate (HCO3), assessed by arterial blood sample
Measured: 1 day
Arterial blood gases: lactate
Arterial blood gases: lactate, assessed by arterial blood sample
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Feb 2022
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186987
- Sponsor's protocol ID
- Visa-Versa!-A
- Status last verified
- Jan 2024
- First submitted
- 6 Dec 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller J, Schneider SR, Titz A, Thalmann C, Schwarz EI, Bauer C, Grunig E, Kohler M, Lichtblau M, Ulrich S. Effect of Eccentric Cycling on Oxygen Uptake and Hemodynamics in Patients With Pulmonary Vascular Disease: A Randomized Controlled Crossover Trial. CHEST Pulm. 2024 Mar 29;2(2):100054. doi: 10.1016/j.chpulm.2024.100054. eCollection 2024 Jun.
PubMed 42548503
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visa-versa! Breaking Instead of Pushing the Pedals: Eccentric Exercise to Improve Training Performance in Patients With Pulmonary Hypertension. A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05186987
- Acronym / sponsor ID
- Visa-Versa!-A
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- 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.
Eccentric muscle work is defined as lengthening of a muscle while applying force. It was shown that with eccentric work, muscles are able to perform four times as much power compared to usual concentric work, which results in huge training gain with a highly decreased oxygen demand and thus lower cardiovascular load. Pulmonary hypertension (PH) is a chronic condition associated with significant reduced exercise capacity and increased morbidity and mortality, resulting in reduced quality of life. Physical training has been shown to be beneficial in PH, even in severely limited patients. However, due to cardiopulmonary constraints in PH, training intensities may be very low, so that many patients are physically almost unable to perform exercise on a high enough level to maintain muscle mass. A low body muscle not only feeds the vicious cycle of decreasing exercise capacity, but also has many deleterious metabolic and immunological consequences which further increase disability and decrease quality of life in PH. Thus, eccentric training, which allows to gain muscle mass with a low stress to the cardiopulmonary unit may to be highly beneficial for patients with PH and allied cardiopulmonary disease, such as chronic obstructive pulmonary disease (COPD) and heart failure. Therefore, the objective of the trial is, to compare differences in oxygen uptake (peak VO2 [l/min]) and other physiological measures during similar cardiopulmonary exercise test protocols of eccentric- vs. concentric cycling in PH- patients and comparators with or without other cardiopulmonary diseases.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start with: Concentric (normal) cycling | Sham comparator | Procedure: 15 minutes eccentric cycling, Procedure: 15 minutes concentric (normal) cycling |
| Start with: Eccentric cycling | Experimental | Procedure: 15 minutes eccentric cycling, Procedure: 15 minutes concentric (normal) cycling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in a stable condition on the same disease specific medication >4 weeks.
- Signed informed consent.
- Precapillary pulmonary hypertension (PH) diagnosed according to international guidelines: mean pulmonary artery pressure (mPAP) ≥25 mmHg and pulmonary artery wedge pressure (PAWP) ≤15 mmHg, pulmonary vascular resistance >2 WU, measured by right heart catherization and clinically diagnosed as Pulmonary arterial and chronic thromboembolic pulmonary hypertension, class 1 or class 4
Key exclusion criteria (5 listed)
- 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.
- Enrolment into another clinical trial with active treatment.
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 |
|---|---|---|
| 15 minutes eccentric cyclingThe exposure to eccentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes. | Procedure or surgery | Start with: Concentric (normal) cycling, Start with: Eccentric cycling |
| 15 minutes concentric (normal) cyclingThe exposure to concentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes. | Procedure or surgery | Start with: Concentric (normal) cycling, Start with: Eccentric cycling |
Primary outcome
Oxygen uptake (peak VO2 [l/min])
Time frame: 1 Day
Difference in oxygen uptake (peak VO2 [l/min]) of eccentric vs. concentric cycling exercise.
15 secondary outcomes
Respiratory exchange ratio (RER)
Time frame: 1 day
Breathing equivalent for carbon dioxide
Time frame: 1 day
Pulmonary end tidal carbon dioxide (PET CO2)
Time frame: 1 day
Arterial oxygen saturation (SpO2)
Time frame: 1 day
Borg Scale for dyspnea
Time frame: 1 day
Borg Scale for leg fatigue
Time frame: 1 day
Cardiac output
Time frame: 1 day
Pulmonary Artery Pressure
Time frame: 1 day
Blood pressure
Time frame: 1 day
Brain tissue oxygenation
Time frame: 1 day
Muscle tissue oxygenation
Time frame: 1 day
Arterial blood gases: PH
Time frame: 1 day
Arterial blood gases: Partialpressure for oxygen (PaO2)
Time frame: 1 day
Arterial blood gases: Bicarbonate (HCO3)
Time frame: 1 day
Arterial blood gases: lactate
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 42548503Muller J, Schneider SR, Titz A, Thalmann C, Schwarz EI, Bauer C, Grunig E, Kohler M, Lichtblau M, Ulrich S. Effect of Eccentric Cycling on Oxygen Uptake and Hemodynamics in Patients With Pulmonary Vascular Disease: A Randomized Controlled Crossover Trial. CHEST Pulm. 2024 Mar 29;2(2):100054. doi: 10.1016/j.chpulm.2024.100054. eCollection 2024 Jun.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 minutes eccentric cycling and 15 minutes concentric (normal) cycling in people with Pulmonary Hypertension, run by University of Zurich at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oxygen uptake (peak VO2 [l/min]) (time frame: 1 Day). 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 NCT05186987, which also lists 1 linked publication.
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 30 Jan 2024.