None listed
Conditions
Brief summary
Peripheral artery disease (PAD) is a disease that leads to a reduction in blood flow to the legs. This study looks at the feasibility of using heart rehabilitation, which is well established in Australia, to help patients with PAD. We will conduct an 8-week supervised exercise program for patients with PAD and provide a medical risk assessment, education and counselling, and address lifestyle factors (diet, exercise, medication use), and how you’re feeling. After 8 weeks of supervised exercise, you will be prescribed a home exercise program. After 6 months, we will re-assess your ability to walk, as well as your symptoms, strength, and overall state of health and well-being. The exercise program will be tailored to your ability. We believe using the heart model for exercise, education and counselling will help to improve physical activity, symptoms, and quality of life in patients with PAD, similar to those with heart problems.
Interventions
Each participant will start their individualised exercise program by walking on a treadmill at a natural gait speed chosen by the patient. Walking intensity will be monitored using a claudication rating scale (i.e. where 0=no pain; 1=onset of pain; 2=mild; 3=mild-to-moderate; 4=moderate; 5=maximum), and exercise that induces claudication pain of a moderate severity (i.e. 3 to 4 out of 5) will be prescribed. When this target is achieved, the participant will be asked to stop walking and will be instructed to continue exercising using an alternative method of resistance training (either leg press, calf press, chest press or seated row) or aerobic exercise (arm ergometer, stationary bike). Moderate exercise intensity will be targeted for the alternative exercises, commencing at a rating of perceived exertion (RPE) of 13-15 on a 20-point BORG scale. For resistance training, a moderate exercise intensity of 60% of 1 repetition maximum (1RM) will be prescribed and participants will undertake 3 sets of 8 repetitions. After sufficient time to recover from claudication pain, participants will return to the treadmill and resume walking again until they reach a level of exercise that induces moderate claudication pain, and then again switch to an alternative method of resistance or aerobic exercise. Participants will continue to alternate between walking at a moderate level and alternative exercises until 30 minutes of aerobic exercise has been completed and all 4 of the resistance training exercise have been completed. The participants heart rate and blood pressure will be monitored throughout exercise, to assess for an exaggerated response to exercise that may lead to early cessation, as well as to help determine the appropriate intensity of exercise using the 20-point BORG scale. This exercise will be prescribed by an accredited exercise physiologist and investigator (B. Parmenter) and the type and intensity of exercises will be documented in the participants records. Each participant will attend 2 x supervised exercise training sessions per week, lasting for 1-2 hours in duration, and attendance at these visits will be documented in the participants records. The cardiac rehabilitation centres at each participating site have fully equipped gyms, and they will be used for delivering supervised exercise programs. This exercise program follows current best-practice guidelines, recommended by the Exercise and Sports Science Australia (ESSA), as outlined in the a position statement on exercise prescription for patients with peripheral artery disease and intermittent claudication: Askew C.D., Parmenter B et.al., Journal of Science and Medicine in Sport; 2014:17:623-9. In addition, the supervised exercise program will incorporate other strategies designed for medical optimisation, including a review of the participants comorbidities, risk factors for atherosclerotic cardiovascular disease, and the appropriate use of optimal guideline-directed medical therapy to achieve recommended therapeutic targets for traditional risk factors (including total cholesterol, LDL-cholesterol, blood pressure, and HbA1c). Medication compliance will be assessed and documented in the participants records. Counselling will be provided on the importance of medication use, the health benefits of medication use and compliance, common side effects and when to be worried. Behavioural modification will also be offered in the form of counselling on healthy lifestyle choices, including the importance of a healthy diet and compliance with exercise, achieving weight loss, and smoking cessation, if appropriate. Personal health goals will be set with the participant using shared decision making and advice will be given on self-management regarding positive lifestyle changes, including identifying current tobacco smoking and providing recommendations for successful cessation, referrals to the Quit Line and the Get Healthy Service. Support for this level of self-management will also be offered as per usual cardiac rehab programs, targeting motivational and behavioural change strategies to help participants to comply with exercise goals, and a healthy lifestyle. A HADS depression score will be used to assess for depression at baseline and form a basis to guide further counselling and/or therapy specifically targeting mental health. These aspects of the supervised rehabilitation program will be delivered by study nurses at each site (Nursing Unit Manager’s: Alexander Slattery at Liverpool Hospital and Wendy Mullooly at Sutherland Hospital), and study cardiologist, with second weekly review by the study cardiologist to maximise medical therapy. Following the 8-week program, participants will be given a long-term, evidence-based home exercise program, written by exercise physiologist and advised to follow up with their GP.
Sponsors
Study design
Eligibility
Inclusion criteria
1) aged >=18 years. 2) a diagnosis of lower limb PAD established by a medical practitioner. 3) clinically stable PAD (i.e. stable intermittent claudication for at least 3 months not requiring revascularisation). 4) ability to walk. 5) community-dwelling (i.e. not residing in a nursing home or hostel). 6) able to consent to participate in the study. 7) competent in English at a level sufficient for study participation unless a translator is available. 8) able to participate in the study and comply with the study requirements over 6 months.
Exclusion criteria
1) persons who are already enrolled in another study and/or; 2) an absolute or relative contraindication to participate in, or successfully complete, an exercise-based rehabilitation program, including: i) women who are pregnant ii) participants with lower limb pain at rest due to PAD iii) those with tissue loss or gangrene due to PAD iv) unstable heart disease v) severe heart failure or other severe heart condition vi) unstable aneurysm or ballooning of artery as diagnosed by a medical specialist vii) rapidly progressive or terminal illness viii) severe memory problems due to dementia ix) severe psychosis or psychological illness x) current active substance (drug or alcohol) abuse