Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome (ETERecaVSPT)

Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT

Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.

Study Overview

• Status: Completed
• Conditions: Post Thrombotic Syndrome; Claudication, Intermittent; Venous Thromboses
• Intervention / Treatment: Diagnostic test: Stress test

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

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Hôpital Arnaud de Villeneuve - CHU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)
• Age >= 18 years

Exclusion Criteria:

• Contraindication to the performance of a maximal effort test on a cyclo-ergometer
• Refusal of consent after information
• Adult protected by law (guardianship, curatorship)
• Pregnant or breastfeeding woman
• Patient not affiliated to a social security system or not benefiting from such a system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress test; All patients will undergo a stress test before and after venous recanalization.	Diagnostic test: Stress test; Diagnostic Test: Maximum effort test (CPET) on a cycloergometer; Leg muscle strength assessment; Leg muscle mass, composition and water compartments (segmental bioelectrical impedance); Spirometry, arterial blood gaz, NO/CO transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max	Change in VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise from baseline to 8 weeks. It is measured in liters of O2 per minute	From baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum aerobic power (in Watts)	Maximum aerobic power is measured in watts before and after venous recanalization	From baseline and 8 weeks
Isowork power	The isowork power is the power output assessed at the V'O2max before recanalization	From baseline and 8 weeks
Maximal exercise cardiac output (in litres per minute)	Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization	From baseline and 8 weeks
Exercise change in Inspiratory capacity (in litres)	Exercise change in Inspiratory capacity is the change between rest and peak exercise of the inspiratory capacity (the volume between end-expiratory volume and total lung capacity) before and after venous recanalization	From baseline and 8 weeks
Maximal exercise capillary volume (in millilitres)	Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization	From baseline and 8 weeks
Maximal exercise O2 arterial pressure (PaO2, in mmHg)	Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization	From baseline and 8 weeks
Maximal isometric torque during leg extension (in Newton.meters)	Maximal isometric strength during leg extension is the maximal torque of the leg extension at 90° knee flexion assessed by a torque sensor before and after venous recanalization	From baseline and 8 weeks
Lower limb extracellular/total water (in %)	Lower limb extracellular/total water is the water volume int the body compartments in each lower limb, assessed by a segmental bioelectrical impedancemeter before and after venous recanalization	From baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: inferior vena cava; iliac vein; exercice tolerance; cardio-pulmonary exercice testing; muscle physiological testing
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Peripheral Arterial Disease; Syndrome; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome; Intermittent Claudication
• Other Study ID Numbers: RECHMPL22_0560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No