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Healthy (Controls)NCT05185895

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

A study testing 15 minutes eccentric cycling and 15 minutes concentric (normal) cycling in people with Healthy (Controls), run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 yearsHealthy volunteers can take part
Conditions the study is for
Healthy (Controls)
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
24 participants
Where
1 siteSwitzerland
Study dates
15 Dec 2021to 30 Apr 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • no cardio respiratory diseases

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 (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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Respiratory Clinic, University Hospital of Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Visa-versa! Breaking Instead of Pushing the Pedals: Eccentric Exercise to Improve Training Performance in Healthy Controls. 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.

Being tested
15 minutes eccentric cycling, 15 minutes concentric (normal) cycling

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 groups in NCT05185895
Study groupRoleWhat they receive
Start with: Concentric (normal) cyclingSham comparatorNot described
Receives: Procedure: 15 minutes eccentric cycling; Procedure: 15 minutes concentric (normal) cycling
Start with: Eccentric cyclingExperimentalNot 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.

  1. 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)
  1. Respiratory exchange ratio (RER)

    Volume carbon dioxide devided by the volume of oxygen( VCO2/VO2)

    Measured: 1 day

  2. Breathing equivalent for carbon dioxide

    Minute ventilation divided by volume carbon dioxide (VE/VCO2)

    Measured: 1 day

  3. 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

  4. Arterial oxygen saturation (SpO2)

    Noninvasively measured oxygenation of the hemoglobin by pulse oximetry (Light Sensors)

    Measured: 1 day

  5. Borg Scale for dyspnea

    Patient reported level of dyspnea from 0 to 10 while 10 is the worst

    Measured: 1 day

  6. Borg Scale for leg fatigue

    Patient reported level of leg fatigue from 0 to 10 while 10 is the worst

    Measured: 1 day

  7. Cardiac output

    How many liters blood is the heart able to move in one minute. Assessed by echocardiography.

    Measured: 1 day

  8. 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

  9. Blood pressure

    Systolic and diastolic blood pressure assessed by arm cuff measurement

    Measured: 1 day

  10. Brain tissue oxygenation

    Oxygenation of the brain tissue assessed by light sensors on the forehead

    Measured: 1 day

  11. Muscle tissue oxygenation

    Oxygenation of the muscle tissue assessed by light sensors on the quadriceps muscle

    Measured: 1 day

  12. Arterial blood gases: PH

    Arterial blood gases: PH, assessed by arterial blood sample

    Measured: 1 day

  13. Arterial blood gases: Partialpressure for oxygen (PaO2)

    Arterial blood gases: Partialpressure for oxygen (PaO2), assessed by arterial blood sample

    Measured: 1 day

  14. Arterial blood gases: Bicarbonate (HCO3)

    Arterial blood gases: Bicarbonate (HCO3), assessed by arterial blood sample

    Measured: 1 day

  15. 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.

  1. First posted11 Jan 2022
  2. Study start15 Dec 2021
  3. Primary completion31 Dec 2022
  4. Study completion30 Apr 2023

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05185895
Sponsor's protocol ID
Visa-Versa!-D
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

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 Healthy (Controls), 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 2 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?
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; AzTrials last refreshed its copy on 3 Nov 2026.

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