Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise: Patients randomised to the intervention arm will undergo non-consecutive training sessions three times a week for a period of 12 weeks. The training session is divided into an aerobic and a resistance training component, with a 5-min warm-up (stretching exercises) and a 5-min cool-down (stretching and relaxing exercises). The cardiovascular component will comprise a progressive exercise duration from 30 to 40 minutes, an exercise intensity promoting moderate to severe claudication pain between 8-12 minutes, with rest time until the pain disappears, and a personalised load progression manipulated based on the claudication pain level, reaching a total of 60 minutes of walking per session. The resistance training component will comprise dynamic muscle contraction exercises (Leg extension, unilateral hip extension, and standing calf raise), with a load progression from 50% of 1-estimated one repetition maximum (e-RM) to 80% of 1-eRM.

Usual care: Patients randomised to the active comparator arm will be advised about the importance of lifestyle modification (including general advice to increase walking but without specific recommendations about the exercise program) for a period of 12 weeks.

Study summary

Peripheral arterial disease (PAD) is characterised as an atherosclerotic disease, most common in the lower limbs (aortoiliac, femoropopliteal, and infrapopliteal arterial segments), which causes a decrease in blood flow to the areas adjacent to and posterior to the affected area. Intermittent claudication (IC) is the most common symptom in this disease that appears with exertion and relieves with rest, causing fatigue, cramps, discomfort, or pain in the lower limbs due to limited blood flow to the affected muscles. Supervised physical exercise has emerged as the first line of intervention in improving the symptoms of intermittent claudication and disease progression, and in the last decade there has been an exponential increase in the use of wearable technologies to monitor dose-response. However, the approach used is still simplistic because it is not personalised. In other words, patients with similar diagnoses and symptoms get the same treatment, without personalising the stimulus according to their exercise responses and level of adaptation. With this in mind, this study aims to monitoring the real-time response of a multicomponent exercise programme (cardiovascular and resistance training) to personalise the dose-response, and use artificial intelligence models to gather and analyse vast amounts of data towards grouping/differentiating based on individual responses. The main hypothesis is that a supervised multicomponent exercise programme will improve the functional capacity of patients with PAD in a cluster personalised approach.

Eligibility

Primary outcome measure(s)

• Pain-free walking distance — Baseline and 12 weeks
  Distance until onset of claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
• Maximum walking distance — Baseline and 12 weeks
  Walking distance until maximum claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
• Percentage of muscle deoxygenation — Baseline and 12 weeks
  The percentage of muscle deoxygenation (in %) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).
• Muscle reoxygenation time — Baseline and 12 weeks
  The muscle reoxygenation time (in seconds) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).

Trial sites (3)

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