Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD
- Conditions
- Behavior, HealthIntermittent ClaudicationPeripheral Arterial DiseaseExercise Intervention
- Interventions
- Behavioral: Exercise and Lifestyle Change
- Registration Number
- NCT05260567
- Lead Sponsor
- Northumbria University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Diagnosis of PAD confirmed by ankle-brachial index <0.90 in one or both limbs
- Age >= 40 years
- Able to walk distance >50m
- Live in an area deemed in lowest 30% of super output area from Office of National Statistics
- chronic limb threatening ischemia
- short claudication distance <50m
- severe heart disease (Grade III or IV, New York Heart Association)
- severe ischemic or haemorrhagic stroke or neurodegenerative diseases
- severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic
- blood pressure of more than 100 mm Hg)
- uncontrolled cardiac arrhythmias (unstable angina during the previous month and
- myocardial infarction during the previous month)
- a resting heart rate of more than 120 beats per minute
- has already undergone angioplasty, bypass or other surgical intervention for PAD
- other severe comorbid conditions preventing the ability to engage in physical activity,
- inability or unwillingness to undertake the commitments of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise and Lifestyle Change Exercise and Lifestyle Change Exercise training and lifestyle change Standard Care Exercise and Lifestyle Change Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline.
- Primary Outcome Measures
Name Time Method Acceptability of the program 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.
Feasibility of the program 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)
- Secondary Outcome Measures
Name Time Method Sleep pre and post-12 weeks (Fitbit Charge HR)
Walking Impairment Questionnaire (WIQ) pre and post-12 weeks Short Form Dietary Questionnaire pre and post-12 weeks Patient activation pre and post-12 weeks The Patient Activation Measure (PAM®)
Walking Estimated Limitation Calculated by History (WELCH) questionnaire pre and post-12 weeks Mental wellbeing pre and post-12 weeks hospital anxiety-depression score (HADS)
Six-minute walk test (6MWT) 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 Physical activity levels (Fitbit Charge HR) pre and post-12 weeks Resource utilisation pre and post-12 weeks The case report forms (CRF)
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
Trial Locations
- Locations (1)
Freeman Hospital - Newcastle upon Tyne NHS trust
🇬🇧Newcastle Upon Tyne, United Kingdom