None listed
Conditions
Brief summary
Peripheral artery disease is an atherosclerotic disease characterised by blocked arteries and impaired blood supply to the legs, which causes muscle pain and limits waking capacity and the ability to undertake daily activities. People with peripheral artery disease may undergo lower limb revascularisation to improve or restore leg blood flow. Supervised exercise is an effective therapy that can improve walking capacity and quality of life in people with peripheral artery disease. Supervised exercise training following lower limb revascularisation can further enhance the clinical outcomes of the revascularisation procedure. This is a randomised-controlled trial which will assess the efficacy of a community-based cardiovascular rehabilitation program versus usual care on exercise capacity and quality of life in people who have undergone lower limb revascularisation for peripheral artery disease. If successful, this trial will lead to improved clinical outcomes for people undergoing lower limb revascularisation for peripheral artery disease. This study will provide crucial knowledge for the inclusion and integration of patients with peripheral artery disease into community-based cardiovascular rehabilitation exercise programs.
Interventions
6-week community-based cardiovascular rehabilitation program (intervention condition). Participants randomised to the cardiovascular rehabilitation program will be referred to the cardiovascular rehabilitation program of the Sunshine Coast Hospital and Health Service. The cardiovascular rehabilitation program will be delivered by the research personnel and the cardiovascular rehabilitation team (e.g., nurses, clinical exercise physiologist). During the community-based cardiovascular rehabilitati
6-week community-based cardiovascular rehabilitation program (intervention condition). Participants randomised to the cardiovascular rehabilitation program will be referred to the cardiovascular rehabilitation program of the Sunshine Coast Hospital and Health Service. The cardiovascular rehabilitation program will be delivered by the research personnel and the cardiovascular rehabilitation team (e.g., nurses, clinical exercise physiologist). During the community-based cardiovascular rehabilitation program, participants will attend two 60-minute supervised exercise sessions per week for a total of 6 weeks. During the 6-week program participants will also be provided with exercise guidelines and advice to complete at least 3 home-based walking sessions per week. In addition to the supervised and home-based sessions, participants will attend one education seminar in total during the 6-week program. Following the completion of the cardiovascular rehabilitation program, a member of the research team will provide participants with individualised exercise and physical activity advice (e.g., suggest continuation of exercise program at local gym) with the goal to meet the recommended 150-300 minutes of moderate intensity physical activity levels per week. The exercise and physical activity advice will be provided via a one-to-one discussion lasting 10-15 minutes at the end of the cardiovascular rehabilitation program (e.g., at the post-program assessment point). Supervised exercise sessions During each supervised exercise session participants will be monitored by the cardiovascular rehabilitation team and research personnel. The research personnel will be responsible for the prescription and progression of the exercises. The exercises prescribed to participants will be in accordance with the current exercise guidelines for patients with peripheral artery disease and will include lower limb aerobic exercises (e.g., treadmill walking), lower limb resistance exercises (e.g., calf raises) and upper limb exercises (e.g., arm cycling). The exercise sessions will be mainly driven by limb discomfort. Participants will be encouraged to exercise at a moderate to near-maximal claudication pain threshold (3/4 based on claudication pain scale) or if asymptomatic, exercise at a moderate exercise intensity (3/10 based on Borg-RPE scale). The duration of the treadmill walking will progressively increase from 10 minutes at the beginning of the program (i.e., week 1) to 30 minutes at the end of the program (i.e., week 6). Home-based walking sessions In addition to the supervised exercise sessions, participants will be provided with home-based exercise guidelines and advice to complete at least 3 home-based walking sessions per week. Participants will be encouraged to walk at a moderate to near-maximal claudication pain threshold (3/4 based on claudication pain scale) or if asymptomatic, walk at a moderate exercise intensity (3/10 based on Borg-RPE scale). Similar to the supervised exercise sessions, duration of home-based walking sessions will progressively increase from 10 minutes at the beginning of the program (i.e., week 1) to 30 minutes at the end of the program (i.e., week 6). Participants will be provided with a diary to record their home-based walking sessions. Education seminar Participants will also attend one education seminar (5.5 hours with breaks for morning tea and lunch) during the 6-week program which will be delivered by health specialists including, nurses, exercise physiologists, dietitians, and psychologists. The education seminar will cover topics such as diet, medications, exercise, physical activities, and lifestyle modifications for secondary prevention of cardiovascular diseases. The seminar information will be based on the Australian dietary guidelines, the physical activity and exercise guidelines for Australians, the Australian clinical guidelines for the management of acute coronary syndromes, and the heart foundation guidelines. Attendance to the education seminars will be assessed using an attendance checklist. If a participant is non-compliant this will be recorded. Participants randomised to the cardiovascular rehabilitation program will continue to receive their usual care and medical advice by their local doctor or vascular surgeon.
Sponsors
University of the Sunshine Coast
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult (18 years old or greater) with a formal diagnosis of PAD by a vascular surgeon. 2. Have had lower limb revascularisation procedure (i.e., angioplasty, bypass, hybrid) in the previous 12 months. 3. Clearance and approval to participate from the treating vascular surgeon, including verification that the patient has adequately recovered from any recent (< 6 weeks) lower limb revascularisation procedure. 4. Able to understand and communicate in English sufficient to complete the informed consent.
Exclusion criteria
1. Unable to walk independently. 2. Previous lower limb amputation or current tissue necrosis (ulceration or gangrene) that limits the ability to undertake walking tests. 3. Deemed not eligible to particate in cardiovascular rehabilitation for reasons such as: unstable angina, acute heart failure, recent cerebrovascular event, uncontrolled resting hypertension (resting SBP > 180mmHg, resting DBP > 100mmHg), uncontrolled diabetes, symptomatic hypotension, uncontrolled sinus tachycardia (> 100bpm), uncontrolled/complex arrythmias. Eligibility for cardiovascular rehabilitation will be determined by the cardiovascular rehabilitation clinical staff as per standard clinical guidelines. 4. Currently participating in a supervised exercise rehabilitation program. 5. Terminal illness or other medical condition or planned treatment that may affect the ability to participate or complete the trial.
Outcome results
None listed