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Visa-versa! Breaking Instead of Pushing the Pedals-C

Primary Purpose

Left Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
15 minutes eccentric cycling
15 minutes concentric (normal) cycling
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • In a stable condition on the same disease specific medication >4 weeks.
  • Signed informed consent.
  • Patients with left-heart disease

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.

Sites / Locations

  • Respiratory Clinic, University Hospital of ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Start with: Concentric (normal) cycling

Start with: Eccentric cycling

Arm Description

Outcomes

Primary Outcome Measures

Oxygen uptake (peak VO2 [l/min])
Difference in oxygen uptake (peak VO2 [l/min]) of eccentric vs. concentric cycling exercise.

Secondary Outcome Measures

Respiratory exchange ratio (RER)
Volume carbon dioxide devided by the volume of oxygen( VCO2/VO2)
Breathing equivalent for carbon dioxide
Minute ventilation divided by volume carbon dioxide (VE/VCO2)
Pulmonary end tidal carbon dioxide (PET CO2)
The level of carbon dioxide that is released at the end of an exhaled breath
Arterial oxygen saturation (SpO2)
Noninvasively measured oxygenation of the hemoglobin by pulse oximetry (Light Sensors)
Borg Scale for dyspnea
Patient reported level of dyspnea from 0 to 10 while 10 is the worst
Borg Scale for leg fatigue
Patient reported level of leg fatigue from 0 to 10 while 10 is the worst
Cardiac output
How many liters blood is the heart able to move in one minute. Assessed by echocardiography.
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
Blood pressure
Systolic and diastolic blood pressure assessed by arm cuff measurement
Brain tissue oxygenation
Oxygenation of the brain tissue assessed by light sensors on the forehead
Muscle tissue oxygenation
Oxygenation of the muscle tissue assessed by light sensors on the quadriceps muscle
Arterial blood gases: PH
Arterial blood gases: PH, assessed by arterial blood sample
Arterial blood gases: Partialpressure for oxygen (PaO2)
Arterial blood gases: Partialpressure for oxygen (PaO2), assessed by arterial blood sample
Arterial blood gases: Bicarbonate (HCO3)
Arterial blood gases: Bicarbonate (HCO3), assessed by arterial blood sample
Arterial blood gases: lactate
Arterial blood gases: lactate, assessed by arterial blood sample

Full Information

First Posted
December 6, 2021
Last Updated
November 10, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05204693
Brief Title
Visa-versa! Breaking Instead of Pushing the Pedals-C
Official Title
Visa-versa! Breaking Instead of Pushing the Pedals: Eccentric Exercise to Improve Training Performance in Patients With Heart Failure. A Single-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Start with: Concentric (normal) cycling
Arm Type
Sham Comparator
Arm Title
Start with: Eccentric cycling
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
15 minutes eccentric cycling
Intervention Description
The exposure to eccentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
Intervention Type
Procedure
Intervention Name(s)
15 minutes concentric (normal) cycling
Intervention Description
The exposure to concentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.
Primary Outcome Measure Information:
Title
Oxygen uptake (peak VO2 [l/min])
Description
Difference in oxygen uptake (peak VO2 [l/min]) of eccentric vs. concentric cycling exercise.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Respiratory exchange ratio (RER)
Description
Volume carbon dioxide devided by the volume of oxygen( VCO2/VO2)
Time Frame
1 day
Title
Breathing equivalent for carbon dioxide
Description
Minute ventilation divided by volume carbon dioxide (VE/VCO2)
Time Frame
1 day
Title
Pulmonary end tidal carbon dioxide (PET CO2)
Description
The level of carbon dioxide that is released at the end of an exhaled breath
Time Frame
1 day
Title
Arterial oxygen saturation (SpO2)
Description
Noninvasively measured oxygenation of the hemoglobin by pulse oximetry (Light Sensors)
Time Frame
1 day
Title
Borg Scale for dyspnea
Description
Patient reported level of dyspnea from 0 to 10 while 10 is the worst
Time Frame
1 day
Title
Borg Scale for leg fatigue
Description
Patient reported level of leg fatigue from 0 to 10 while 10 is the worst
Time Frame
1 day
Title
Cardiac output
Description
How many liters blood is the heart able to move in one minute. Assessed by echocardiography.
Time Frame
1 day
Title
Pulmonary Artery Pressure
Description
Right ventricle pressure divided by the right atrium pressure gradient (RV/RA pressure gradient) to assess the systolic pulmonary artery pressure by echocardiography
Time Frame
1 day
Title
Blood pressure
Description
Systolic and diastolic blood pressure assessed by arm cuff measurement
Time Frame
1 day
Title
Brain tissue oxygenation
Description
Oxygenation of the brain tissue assessed by light sensors on the forehead
Time Frame
1 day
Title
Muscle tissue oxygenation
Description
Oxygenation of the muscle tissue assessed by light sensors on the quadriceps muscle
Time Frame
1 day
Title
Arterial blood gases: PH
Description
Arterial blood gases: PH, assessed by arterial blood sample
Time Frame
1 day
Title
Arterial blood gases: Partialpressure for oxygen (PaO2)
Description
Arterial blood gases: Partialpressure for oxygen (PaO2), assessed by arterial blood sample
Time Frame
1 day
Title
Arterial blood gases: Bicarbonate (HCO3)
Description
Arterial blood gases: Bicarbonate (HCO3), assessed by arterial blood sample
Time Frame
1 day
Title
Arterial blood gases: lactate
Description
Arterial blood gases: lactate, assessed by arterial blood sample
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In a stable condition on the same disease specific medication >4 weeks. Signed informed consent. Patients with left-heart disease 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Ulrich, Prof. Dr.
Phone
+41442552220
Email
silvia.ulrich@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Müller, MSc
Phone
+41784033334
Email
Julian.Mueller2@usz.ch
Facility Information:
Facility Name
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, Prof. Dr.
Phone
+41442554362
Email
silvia.ulrich@usz.ch
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, Prof. Dr.

12. IPD Sharing Statement

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Visa-versa! Breaking Instead of Pushing the Pedals-C

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