Eccentric Cycling Exercise During Pulmonary Rehabilitation in Patients With Cardiopulmonary Diseases

Eccentric cycling exercise (ECC) allows training at low metabolic costs and may therefore be valuable for patients with pulmonary vascular disease (PVD). For these patients, regular exercise training has an evidence level 1A recommendation in the current guidelines. Exercise training during longer and regular periods provides chronic adaptation, for which ECC was recently found to have a greater effectiveness than CON by increasing muscle strength, hypertrophy, six-minute walking distance and furthermore, by increasing maximum oxygen uptake (V'O2max) especially in patients with chronic obstructive pulmonary disease (COPD), chronic left heart failure or coronary heart disease. Furthermore, we conducted an RCT in which we exposed patients with PVD to ECC and concluded that ECC is a feasible and well-tolerated exercise modality for PVD patients with severely lower O2 demand and load to the right ventricle. The study in patients with PVD was started (EccRehab), and the great potential was recognized. Therefore there was an indication to open the inclusion criteria to all cardiopulmonary patients with indication for pulmonary rehabilitation (EccRehab2).

For this purpose, the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with cardiopulmonary diseases.

Study Overview

• Status: Recruiting
• Conditions: Eccentric Exercise Training
• Intervention / Treatment: Other: Eccentric cycling exercise; Other: Standard Care Arm

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Ulrich, Prof. dr. med.; Phone Number: +41442564362; Email: silvia.ulrich@usz.ch
• Study Contact Backup: Name: Julian Müller, Dr. sc. med.; Phone Number: 0432539349; Email: julian.mueller2@usz.ch

Study Locations

• Switzerland
  • Barmelweid, Switzerland, 5017
    • Recruiting
    • Klinik Barmelweid
    • Contact: Thomas Sigrist, Dr. med.; Phone Number: 062 857 20 00; Email: thomas.sigrist@barmelweid.ch
  • Zürich, Switzerland, 8092
    • Recruiting
    • Universitatsspital Zurich
    • Contact: Silvia Ulrich, Prof. dr. med.; Phone Number: 0432539349; Email: silvia.ulrich@usz.ch
    • Contact: Julian Müller, Dr. sc. med.; Email: julian.mueller2@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with PVD, either PAH or CTEPH via right heart catheterization, according to recent guidelines [9]
• Diagnosed with a cardiopulmonary disease as indication for a pulmonary rehabilitation
• Stable medication for at least 1 month
• Age 18years to 85 years
• No resting hypoxemia (PaO2 >7.3 kPa)
• Medical indication to prescibe a pulmonary rehabilitation

Exclusion Criteria:

• Any co-morbidity that limits the patient to participate the full rehabilitation
• Enrollments in other trials with active treatments
• Language barriers that limits the patient to participate in the rehabilitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eccentric cycling; Patients perform eccentric cycling exercise instead of normal cycling exercise in addition to standard car during a cardiopulmonary rehabilitation	Other: Eccentric cycling exercise; Patients perform eccentric cycling exercise instead of normal cycling exercise in addition to standard car during a cardiopulmonary rehabilitation
Active Comparator: Standard care; Patients perform cardiopulmonary rehabilitation according to standard care	Other: Standard Care Arm; Patients perform cardiopulmonary rehabilitation according to standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak exercise performance [Watts]	Peak exercise performance is measured during cardiopulmonary exercise tests on a cycle ergometer. The Unit of the measurement is watts.	At baseline pre-intervention and immediately after three weeks of rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake [L/min]	Peak oxygen uptake is measured during cardiopulmonary exercise tests on a cycle ergometer. The Unit of the measurement is liters per minute.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Ventilatory equivalents for carbon dioxide (Minute ventilation / carbon dioxide output)	Ventilatory equivalents for carbon dioxide is measured during cardiopulmonary exercise tests on a cycle ergometer. The measurement is a ratio without a unit (VE/VCO2).	At baseline pre-intervention and immediately after three weeks of rehabilitation
Six minute walk distance [meters]	The maximal distance that a patient is able to walk within six minutes. The unit of the measurement is meters.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Knee extension test [repetitions]	The patients has to stad up from a chair and sit down as often the patient is able to do this within 1 minute. The unit of the measurement is repetitions.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Systolic pulmonary arterial pressure [mmHg]	The sytolic pulmonary arterial pressure is measured by echocardiography using continuous wave doppler at the tricuspid valve. The unit of the measurement is mmHg.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Total pulmonary reistance [Wood units]	The total pulmonary resistance is measured by echocardiography by dividing the systolic pulmonary arterial pressure by the cardiac output. The unit of the measurement is woos units.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Right ventricular to arterial coupling [mm/mmHg]	The right ventricular arterial coupling is measured by echocardiography dividing the tricuspid annular plane systolic excursion by the systolic arterial pressure. the unit is mm/mmHg.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Cardiac output [L/min]	The cardiac output is measured by echocardiography using the left ventricular outflow tract velocity time integral assessed by pulse wave doppler. The unit of the measurement is L/min.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Arterial partial pressure for oxygen [kPa]	The arterial partial pressure for oxygen is measured by taking a arterial blood sample from the arteria radialis at peak exercise and analyze it in a radiometer. The unit of the measurement is kPa.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Arterial partial pressure for carbon dioxide [kPa]	The arterial partial pressure for carbon dioxide is measured by taking a arterial blood sample from the arteria radialis at peak exercise and analyze it in a radiometer. The unit of the measurement is kPa.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Arterial oxygen saturation [%]	The arterial oxygen saturation is measured by taking a arterial blood sample from the arteria radialis at peak exercise and analyze it in a radiometer. The unit of the measurement is %.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Patient reported leg fatigue [scale from 1 to 10]	Patients perceived leg fatigue is assessed at peak exercise on the Borg CR 10 scale. The unit of the measurement is a scale from 1 to 10.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Patient reported dyspnea [scale from 1 to 10]	Patients perceived dyspnea is assessed at peak exercise on the Borg CR 10 scale. The unit of the measurement is a scale from 1 to 10.	At baseline pre-intervention and immediately after three weeks of rehabilitation
Patient reported quality of life [cm]	The patient reported quality of life is assessed by the visual analogue scale, where the patient has to draw on a 10 cm long line where left is "bad" and right is "very good". The unit of the measurement is cm.	At baseline pre-intervention and immediately after three weeks of rehabilitation

Collaborators and Investigators

• Sponsor: Silvia Ulrich Somaini
• Collaborators: Klinik Barmelweid

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: June 10, 2025
• First Submitted That Met QC Criteria: June 19, 2025
• First Posted (Actual): June 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; Eccentric cycling exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: EccRehab2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No