Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD

Northumbria University

Status: Completed

Conditions: Exercise Intervention; Intermittent Claudication; Behavior, Health; Peripheral Arterial Disease

Treatments: Behavioral: Exercise and Lifestyle Change

Study type: Interventional

Funder types: Other

Identifiers

NCT05260567

286735

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exercise and Lifestyle Change

Experimental group

Description:

Exercise training and lifestyle change

Treatment:

Behavioral: Exercise and Lifestyle Change

Standard Care

Other group

Description:

Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline.

Treatment:

Behavioral: Exercise and Lifestyle Change