Regular Exercise for Peripheral Arterial Ischaemia: a Randomised Intervention Trial

Not Applicable

• Conditions: Intermittent Claudication; Peripheral Arterial Disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12609000457246
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Men and women over the age of 50 who suffer from moderate to severe intermittent claudication from PAD as defined by lower extremity ultrasound in Professor Lord’s vascular laboratory will be recruited for this trial. Participants must be sedentary, ambulatory and community dwelling with no contra-indications to progressive resistance training. All participants must be clinically stable for 3 months prior to enrolment in the trial. Clinically stable will be defined as no significant change in claudication symptoms over a 3-month no treatment run-in period, as determined by the 6-minute walk test performed twice at baseline, 3-months apart.
We will preferentially recruit elderly (over the age of 70 years) and female participants, as these cohorts have been understudied in the past. Specifically, persons with diabetes, hypertension, coronary artery disease and/or a history of myocardial infarction will not be excluded. Persons who have had previous surgical intervention and/or who are on pharmaceutical treatment for symptoms of PAD will also not be excluded.

Exclusion Criteria

Exclusionary criteria include asymptomatic PAD, mild intermittent claudication (>200m initial claudication walking distance), ischaemic rest pain, tissue necrosis or gangrene, significant cognitive impairment, current alcohol or substance abuse, inability to comply with study requirements over the course of 6 months (including baseline and final assessments), those currently undertaking a resistance training or other regular (at least 3 days per week) moderate to high intensity exercise of any kind, and those confined to a nursing home or hostel or who are unable to perform PRT safely under supervision. Persons with specific contraindications to resistance training exercise such as unstable cardiovascular disease, aortic aneurysm, symptomatic hernias, proliferative diabetic retinopathy, retinal laser surgery within 6 weeks, uncontrolled hypertension or rapidly progressive or terminal illness will also be excluded. Persons who are currently actively awaiting surgical intervention for PAD will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Initial claudication distance: The distance at which the participant first experiences claudication pain will be measured during a graded treadmill walking test.[Baseline prior to commencement of the treatment program and at 6 months after completion of the 6 month program.];Absolute claudication distance: The distance at which a person can no longer ambulate due to intense claudication pain will be measured during a graded treadmill walking test.[Baseline prior to commencement of the treatment program and at 6 months after completion of the 6 month program.];6 minute walk distance will be measured using a pedometer and stopwatch.[Baseline prior to commencement of the treatment program and at 6 months after completion of the 6 month program.]