Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05186987 |
| Other study ID # |
Visa-Versa!-A |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2022 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
