Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD
Study Details
Study Description
Brief Summary
Peripheral arterial disease is a common, undertreated 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 main stay 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.
We proposed 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. We will also be embedding focus groups to understand patients experience of the intervention and whether the intervention 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise and Lifestyle Change Exercise training and lifestyle change |
Behavioral: Exercise and Lifestyle Change
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%.
|
| Other: Standard Care Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline. |
Behavioral: Exercise and Lifestyle Change
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%.
|
Outcome Measures
Primary Outcome Measures
- Feasibility Outcomes [post 12 weeks]
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)
- Acceptability [post 12 weeks]
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.
Secondary Outcome Measures
- 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 [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 [pre and post-12 weeks]
(Fitbit Charge HR)
- Alcohol and tobacco use [pre and post-12 weeks]
The 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and self-reported smoking habits
- Mental wellbeing [pre and post-12 weeks]
hospital anxiety-depression score (HADS)
- Patient activation [pre and post-12 weeks]
The Patient Activation Measure (PAM®)
- Resource utilisation [pre and post-12 weeks]
The case report forms (CRF)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of PAD confirmed by ankle-brachial index <0.90 in one or both limbs
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Age >= 40 years
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Able to walk distance >50m
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Live in an area deemed in lowest 30% of super output area from Office of National Statistics
Exclusion Criteria:
-
chronic limb threatening ischemia
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short claudication distance <50m
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severe heart disease (Grade III or IV, New York Heart Association)
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severe ischemic or haemorrhagic stroke or neurodegenerative diseases
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severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic
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blood pressure of more than 100 mm Hg)
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uncontrolled cardiac arrhythmias (unstable angina during the previous month and
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myocardial infarction during the previous month)
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a resting heart rate of more than 120 beats per minute
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has already undergone angioplasty, bypass or other surgical intervention for PAD
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other severe comorbid conditions preventing the ability to engage in physical activity,
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inability or unwillingness to undertake the commitments of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Freeman Hospital - Newcastle upon Tyne NHS trust | Newcastle Upon Tyne | United Kingdom |
Sponsors and Collaborators
- Northumbria University
Investigators
- Principal Investigator: James Prentis, Freeman Hospital - Newcastle upon Tyne NHS trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 286735