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

NCT05185856 | Completed

• 1 other identifier: Visa-Versa!-B
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 aim of the study 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Oxygen uptake (peak VO2 [l/min])

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

  1 Day

Secondary Outcomes (15)

• Respiratory exchange ratio (RER)

  1 day

• Breathing equivalent for carbon dioxide

  1 day

• Pulmonary end tidal carbon dioxide (PET CO2)

  1 day

• Arterial oxygen saturation (SpO2)

  1 day

• Borg Scale for dyspnea

  1 day

Study Arms (2)

Start with: Concentric (normal) cycling

SHAM COMPARATOR

Patients that are allocated to this arm will start with normal cycling

Procedure: 15 minutes eccentric cycling; Procedure: 15 minutes concentric (normal) cycling

Start with: Eccentric cycling

EXPERIMENTAL

Patients that are allocated to this arm will start with eccentric cycling

Procedure: 15 minutes eccentric cycling; Procedure: 15 minutes concentric (normal) cycling

Interventions

15 minutes eccentric cycling PROCEDURE

The exposure to eccentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.

Start with: Concentric (normal) cycling; Start with: Eccentric cycling

15 minutes concentric (normal) cycling PROCEDURE

The exposure to concentric exercise will be individualized-intensity stepwise incremental cycle exercise starting at 50 Watt with individually tailored increments every 5 minutes.

Start with: Concentric (normal) cycling; Start with: Eccentric cycling

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In a stable condition on the same disease specific medication \>4 weeks.
• Signed informed consent.
• Patients with chronic obstructive pulmonary (COPD) with a FEV1/FVC-ratio \> 0.7

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 11, 2022
• Study Start: November 15, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)