Eccentric Cycling Exercise During Pulmonary Rehabilitation Pulmonary Vascular Disease

Eccentric Cycling Exercise During Pulmonary Rehabilitation in Pulmonary Vascular Disease

Eccentric cycling allows high intensities with low metabolic costs. Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD

Study Overview

• Status: Recruiting
• Conditions: Eccentric Cycling Exercise
• Intervention / Treatment: Procedure: Rehabilitation with eccentric cycling exercise; Procedure: normal rehabilitation

Detailed Description

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, the investigators conducted an RCT in which the investigators 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.

Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Ulrich, Prof; Phone Number: 0442564362; Email: silvia.ulrich@usz.ch
• Study Contact Backup: Name: Julian Müller, Msc; Phone Number: 0432539349; Email: Julian.Mueller2@usz.ch

Study Locations

• Switzerland
  • Erlinsbach, Switzerland, 5017
    • Recruiting
    • Rehabilitation clinic Barmelweid
    • Contact: Thomas Sidrist, md; Phone Number: 062 857 21 11; Email: info@barmelweid.ch
  • Zurich, Switzerland
    • Recruiting
    • University Hospital Zurich, Pneumology
    • Principal Investigator: Silvia Ulrich Somaini, MD
    • Sub-Investigator: Florian Hildenbrand, MD

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 according to recent guidelines
• Stable medication for at least 1 month
• Age 18 to 85 years
• No resting hypoxemia (PaO2 >7.3kPa)

Exclusion Criteria:

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

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 exercise	Procedure: Rehabilitation with eccentric cycling exercise; Instead of normal cycling, patients will exercise on the eccentric bike.
Active Comparator: Concentric cycling exercise	Procedure: normal rehabilitation; Normal rehabilitation will be conducted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
peak exercise capacity	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake	Assesses during exercise until exhaustion using an incremental exercise protocol	3 weeks
ventilatory equivalent for CO2		3 weeks
Finger pulseoximetry	Arterial oxygen saturation will be assessed by finger clip Infrared spectroscopy	3 weeks
6 minute walk distance		3 weeks
systolic pulmonary artery pressure		3 weeks
total pulmonary resistance		3 weeks
ventricular - pulmonary arterial coupling		3 weeks
cardiac output	will be assessed by echocardiography using the pulse-wave doppler technique at the left ventricular outflow tract durig systole.	3 weeks
Arterial partial pressure for oxygen	Arterial blood gas analyses, taken from the radial artery and analysed by radiometer	3 weeks
Arterial partial pressure for carbon dioxide	Arterial blood gas analyses, taken from the radial artery and analysed by radiometer	3 weeks
Arterial oxygen saturation	Arterial blood gas analyses, taken from the radial artery and analysed by radiometer	3 weeks
Arterial lactate concentration	Arterial blood gas analyses, taken from the radial artery and analysed by radiometer	3 weeks
Borg CR 10 for perceived dyspnea		3 weeks
Borg CR 10 for perceived leg fatigue		3 weeks
Visual analogue scale generell well being		3 weeks
Visual analogue scale dyspnea		3 weeks

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: EccRehab

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