Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Diagnostic Test: transcutaneous oxygen pressure
* Procedure: Supervised Exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PAD with intermittent claudication SET prescribed ABI < 0.9 Beneficiary of French health care insurance Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group Assignment<br>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 | Diagnostic Test: transcutaneous oxygen pressure<br>* External proxe fixed to the skin and ultrasound examination.<br>* Other names: Doppler arterial waveform;Procedure: Supervised Exercise therapy<br>* Supervised exercise therapy consists of three exercise sessions per week for 3 months, combining treadmill walking, lower limb muscle strengthening and stretching exercises. It is considered highly effective for people with leg pain related to peripheral arterial disease and has shown statistically significant improvements in maximum walking distance and quality of life parameters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of oximetry at 3 week from baseline | To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value) | at 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of doppler waveform at 3 week from baseline | To describe the evolution of doppler waveform during SET at 3 weeks from baseline (SB hemodynamic classification) | at 3 weeks | 
| Evolution of doppler waveform at 6 week from baseline | To describe the evolution of doppler waveform during SET at 6 weeks from baseline (SB hemodynamic classification) | 6 weeks | 
| Evolution of doppler waveform at 9 week from baseline | To describe the evolution of doppler waveform during SET at 9 weeks from baseline (SB hemodynamic classification) | 9 weeks | 
| Evolution of doppler waveform at 12 week from baseline | To describe the evolution of doppler waveform during SET at 12 weeks from baseline (SB hemodynamic classification) | 12 weeks | 
| Evolution of oximetry at 6 week from baseline | To describe the evolution of oximetry during SET at 6 weeks from baseline (TcPO2 leg value) | at 6 weeks | 
| Evolution of oximetry at 9 week from baseline | To describe the evolution of oximetry during SET at 9 weeks from baseline (TcPO2 leg value) | at 9 weeks | 
| Evolution of oximetry at 12 week from baseline | To describe the evolution of oximetry during SET at 12 weeks from baseline (TcPO2 leg value) | at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Supervised exercise therapy, arterial waveform, transcutaneous oxygen pressure