Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
- Conditions
- Peripheral Arterial Disease
- Interventions
- Diagnostic Test: transcutaneous oxygen pressureProcedure: Supervised Exercise therapy
- Registration Number
- NCT05818046
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:
* can a significant increase in oxygen pressure be observed at 3 weeks?
* can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks?
- Detailed Description
Peripheral arterial disease (PAD) is a frequent pathology that affects more than 200 million people worldwide, more than 800,000 in France, and is mainly of atheromatous origin. The prevalence of this disease in France is estimated at 11% in people over 40 years of age, with an annual additional cost of €11,000 per patient. Supervised exercise therapy (SET) is the first-line treatment for intermittent claudication PAD for at least 3 months, although 15-20% of patients will not benefit from this therapy. Ankle-Brachial Index, the main diagnostic and monitoring tool for PAD, is not altered during SET. Transcutaneous oximetry (TcPO2) has been used for many years in the diagnosis of chronic permanent ischaemia, in the choice of amputation level and more recently in the diagnosis of proximal PAD.
No studies have investigated the evolution and predictive value of exercise TcPO2 in this context of SET. The assessment of arterial Doppler waveform using an objective classification has also never been performed in the specific context of SET. .
The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:
* can a significant increase in oxygen pressure be observed at 3 weeks?
* can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks.
The perspective is to predict the effectiveness of SET in terms of maximum walking distance.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- PAD with intermittent claudication
- SET prescribed
- ABI < 0.9
- Beneficiary of French health care insurance
- PAD with rest ischemia
- Chronic respiratory failure
- Acute decompensated disease
- Lower limb prosthesis
- Pregnant women and breastfeeding mothers
- Place of residence more than 100 km from Caen University Hospital
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Group Assignment transcutaneous oxygen pressure intervention consiste to non-invasive arterial assessment by doppler (arterial waveform) and external oxygen probe (Transcutaneous oxygen pressure) at 3,6 and 9 weeks of supervised exercise therapy Single Group Assignment Supervised Exercise therapy intervention consiste to non-invasive arterial assessment by doppler (arterial waveform) and external oxygen probe (Transcutaneous oxygen pressure) at 3,6 and 9 weeks of supervised exercise therapy
- Primary Outcome Measures
Name Time Method Evolution of oximetry at 3 week from baseline at 3 weeks To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value)
- Secondary Outcome Measures
Name Time Method Evolution of oximetry at 6 week from baseline at 6 weeks To describe the evolution of oximetry during SET at 6 weeks from baseline (TcPO2 leg value)
Evolution of doppler waveform at 12 week from baseline 12 weeks To describe the evolution of doppler waveform during SET at 12 weeks from baseline (SB hemodynamic classification)
Evolution of doppler waveform at 9 week from baseline 9 weeks To describe the evolution of doppler waveform during SET at 9 weeks from baseline (SB hemodynamic classification)
Evolution of doppler waveform at 3 week from baseline at 3 weeks To describe the evolution of doppler waveform during SET at 3 weeks from baseline (SB hemodynamic classification)
Evolution of doppler waveform at 6 week from baseline 6 weeks To describe the evolution of doppler waveform during SET at 6 weeks from baseline (SB hemodynamic classification)
Evolution of oximetry at 9 week from baseline at 9 weeks To describe the evolution of oximetry during SET at 9 weeks from baseline (TcPO2 leg value)
Evolution of oximetry at 12 week from baseline at 12 weeks To describe the evolution of oximetry during SET at 12 weeks from baseline (TcPO2 leg value)
Trial Locations
- Locations (1)
CHU Caen Normandie
🇫🇷Caen, Normandie, France