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Peripheral arterial disease is a common, under-treated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. NICE has recommended that supervised exercise is the mainstay of treatment for intermittent claudication (ischaemic muscle pain on walking due to blocked and narrowed arteries). However, in the vast majority of UK hospitals, this isn't undertaken, and with the issues around group-based sessions and repeated visits to hospitals, this treatment option is not available with the coronavirus pandemic.
This is a single-centre randomised control trial in 60 patients with peripheral arterial disease attending the Freeman Hospital. Patients will be randomised to either an enhanced behavioural change intervention targeting multiple health behaviours vs a simple walking intervention. Also, some patients will be involved in focus groups to understand their experience of the intervention and whether it is feasible and acceptable, allowing changes to be made to the program.
The primary outcome will be to assess the feasibility and acceptability of the program. We will also be assessing multiple secondary outcomes including functional capacity, quality of life, sleep quality and smoking and alcohol reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and Lifestyle Change | Experimental | Exercise training and lifestyle change |
|
| Standard Care | Other | Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise and Lifestyle Change | Behavioral | Patients will undergo to weekly phone call/videoconference for 12 weeks and discuss the behaviour change. They also will undergo to home-based exercise training will be performed twice a week for 12 weeks via Zoom (up to 5 patients per session). Each session will be comprised of warm-up (10 min), the main part (15 to 20 min), and cooldown (5 to 10 min). The training aims to develop resistance, aerobic and functional capacity such as getting up, walking, pulling, pushing, throwing, transferring body weight or external loads. In addition, patients will be encouraged to increase their physical activity. Patients will be provided with a Fitbit device to monitor their step count and will be recommended to increase their previous week's average step count by 10%. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the program | Feasibility will be determined by calculating the rate of patient screening, eligibility, recruitment, retention at 12 weeks and adherence to the intervention (number of sessions attended and completed) | post 12 weeks |
| Acceptability of the program | Patient acceptability of the intervention and study experience more broadly will be determined through semi-structured qualitative 1-2-1 interviews and/or focus groups. | post 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk test (6MWT) | pre and post-12 weeks | |
| Walking Impairment Questionnaire (WIQ) | pre and post-12 weeks | |
| Walking Estimated Limitation Calculated by History (WELCH) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Prentis | Freeman Hospital - Newcastle upon Tyne NHS trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freeman Hospital - Newcastle upon Tyne NHS trust | Newcastle upon Tyne | United Kingdom |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| pre and post-12 weeks |
| Vascular quality of life questionnaire (VascuQoL-6) | pre and post-12 weeks |
| EuroQoL questionnaire (EQ-5D-5L). | pre and post-12 weeks |
| Short Form Dietary Questionnaire | pre and post-12 weeks |
| Physical activity levels (Fitbit Charge HR) | pre and post-12 weeks |
| Sleep | (Fitbit Charge HR) | pre and post-12 weeks |
| Alcohol and tobacco use | The 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and self-reported smoking habits | pre and post-12 weeks |
| Mental wellbeing | hospital anxiety-depression score (HADS) | pre and post-12 weeks |
| Patient activation | The Patient Activation Measure (PAM®) | pre and post-12 weeks |
| Resource utilisation | The case report forms (CRF) | pre and post-12 weeks |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |