NCT06480656

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started May 2024

Typical duration for not_applicable

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 Progress93%
May 2024Jul 2026

Study Start

First participant enrolled

May 29, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

May 31, 2024

Last Update Submit

June 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • peak exercise capacity

    3 weeks

Secondary Outcomes (16)

  • Peak oxygen uptake

    3 weeks

  • ventilatory equivalent for CO2

    3 weeks

  • Finger pulseoximetry

    3 weeks

  • 6 minute walk distance

    3 weeks

  • systolic pulmonary artery pressure

    3 weeks

  • +11 more secondary outcomes

Study Arms (2)

Eccentric cycling exercise

EXPERIMENTAL
Procedure: Rehabilitation with eccentric cycling exercise

Concentric cycling exercise

ACTIVE COMPARATOR
Procedure: normal rehabilitation

Interventions

Instead of normal cycling, patients will exercise on the eccentric bike.

Eccentric cycling exercise

Normal rehabilitation will be conducted

Concentric cycling exercise

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rehabilitation clinic Barmelweid

Erlinsbach, 5017, Switzerland

RECRUITING

University Hospital Zurich, Pneumology

Zurich, Switzerland

RECRUITING

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Silvia Ulrich, Prof

CONTACT

Julian Müller, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 28, 2024

Study Start

May 29, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations