NCT05818046

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	transcutaneous oxygen pressure	External proxe fixed to the skin and ultrasound examination.
PROCEDURE	Supervised Exercise therapy	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.

Timeline

• Start date: 2023-02-15
• Primary completion: 2025-05-10
• Completion: 2025-11-25
• First posted: 2023-04-18
• Last updated: 2023-08-30

Locations

1 site across 1 country: France