Venous claudication treadmill trial

Recruiting

Conditions: Venous insufficiency. Venous claudication
10014523

Registration Number: NL-OMON55978

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

- Voluntary and mentally competent individuals from 18 years of age
- Understanding of the Dutch language
- Symptoms of venous claudication after a prior DVT with an indication for
endovascular stenting.
- Able to perform a treadmill exercise test.
- Written informed consent

Exclusion Criteria

- Having any other morbidity that prevent patients from performing a walking
test.
- Having any other morbidity that mimics similar symptoms, most of all arterial
claudication
- Inability to give informed consent (cognitive impairments, no good
understanding of the Dutch language)
- Prior vascular intervention for an acute DVT (surgery, interventional
catheter-directed thrombolytic therapy, stent)
- Participating in other research projects that can influence outcomes of this
study (such as venous interventions, physical exercise programs)
- Pregnancy up to 2 months postpartum

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>o Distance in meters on a standardized treadmill test until patients develop<br /><br>known symptoms as tightness and/or pain: initial claudication distance (ICD).<br /><br>o Distance in meters on a standardized treadmill test until patients develop<br /><br>severe known symptoms as tightness and/or pain that compel them to stop<br /><br>walking: absolute claudication distance (ACD).<br /><br>o Time in minutes on a standardized treadmill test until patients develop known<br /><br>symptoms as tightness and/or pain: initial claudication time (ACT).<br /><br>o Time in minutes on a standardized treadmill test until patients develop<br /><br>severe known symptoms as tightness and/or pain that compel them to stop<br /><br>walking: absolute claudication time (ACT).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>o Quality of life using the VEINES-QoL questionnaire<br /><br>o Symptom severity using the VEINES-Sym questionnaire<br /><br>o PTS score using the Villalta score<br /><br>o VAS score<br /><br>o Leg circumference in centimetres using a measuring tape</p><br>