The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.
30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.
| Condition | Peripheral Artery Disease, Intermittent Claudication |
|---|---|
| Treatment | Exercise Group |
| Clinical Study Identifier | NCT05059899 |
| Sponsor | Coventry University |
| Last Modified on | 25 August 2023 |
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