NCT07042750

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
May 2025May 2026

Study Start

First participant enrolled

May 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

June 10, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

Eccentric cycling exercisePulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Peak oxygen uptake [L/min]

    At baseline pre-intervention and immediately after three weeks of rehabilitation

  • Ventilatory equivalents for carbon dioxide (Minute ventilation / carbon dioxide output)

    At baseline pre-intervention and immediately after three weeks of rehabilitation

  • Six minute walk distance [meters]

    At baseline pre-intervention and immediately after three weeks of rehabilitation

  • Knee extension test [repetitions]

    At baseline pre-intervention and immediately after three weeks of rehabilitation

  • Systolic pulmonary arterial pressure [mmHg]

    At baseline pre-intervention and immediately after three weeks of rehabilitation

  • +9 more secondary outcomes

Study Arms (2)

Eccentric cycling

EXPERIMENTAL

Patients perform eccentric cycling exercise instead of normal cycling exercise in addition to standard car during a cardiopulmonary rehabilitation

Other: Eccentric cycling exercise

Standard care

ACTIVE COMPARATOR

Patients perform cardiopulmonary rehabilitation according to standard care

Other: Standard Care Arm

Interventions

Patients perform eccentric cycling exercise instead of normal cycling exercise in addition to standard car during a cardiopulmonary rehabilitation

Eccentric cycling

Patients perform cardiopulmonary rehabilitation according to standard care

Standard care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik Barmelweid

Barmelweid, 5017, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8092, Switzerland

RECRUITING

Central Study Contacts

Silvia Ulrich, Prof. dr. med.

CONTACT

Julian Müller, Dr. sc. med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention: Eccentric cycling (instead of usual cycling) + standard care Control: Standard care
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Silvia Ulrich

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 29, 2025

Study Start

May 2, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations