Post-operative exercise training for peripheral arterial disease

Not Applicable

Recruiting

• Conditions: Peripheral arterial disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Surgery - Other surgery; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12616001232426
• Lead Sponsor: niversity of the Sunshine Coast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients scheduled for lower limb revascularisation, including open surgery (e.g. bypass), an endovascular procedure, or a hybrid procedure (e.g. endarterectomy plus angioplasty);
2. Documented diagnosis of PAD based on symptoms (claudication or critical limb ischaemia), an ABI < 0.90, and imaging evidence of a significant (>50%) stenosis in at least one lower-limb arterial segment;
3. Stable medication and treatment regimen (>3 months);
4. Physician-assessed ability to undertake the intervention and exercise testing.

Exclusion Criteria

1.Not able to walk independently prior to revascularisation, or walking capacity is limited by symptoms not related to PAD (including neuropathy);
2.Have had or are undergoing a significant amputation (e.g. forefoot, leg) that is expected to limit ability to walk independently after surgery;
3.Exercise testing is contraindicated for reasons such as unstable angina, uncontrolled hypertension (>160/100), limiting venous disease or uncontrolled cardiac dysrhythmias;
4.Current or planned involvement in a supervised exercise rehabilitation program.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Walking capacity (6 minute walking distance) [Outcome measurements will be performed at baseline prior to revascularisation, then repeated following full recovery from revascularisation (2-6 weeks post-procedure), and then again at the completion of the 8 week post-operative intervention];Calf muscle microvascular blood flow (using contrast-enhanced ultrasound [CEU])[Outcome measurements will be performed at baseline prior to revascularisation, then repeated following full recovery from revascularisation (2-6 weeks post-procedure), and then again at the completion of the 8 week post-operative intervention]