Clinical trial NCT05260567: Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD
Official title: A Multimodal Tele-health Behavioural Intervention in Patients With Peripheral Arterial Disease From Low Socio-economic Areas: a Feasibility and Pilot Randomized Controlled Trial With Embedded Process Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Behavior, Health
Exercise Intervention
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the program
timeFrame: post 12 weeks
measure: Acceptability of the program
timeFrame: post 12 weeks
Secondary outcomes:
measure: Six-minute walk test (6MWT)
timeFrame: pre and post-12 weeks
measure: Walking Impairment Questionnaire (WIQ)
timeFrame: pre and post-12 weeks
measure: Walking Estimated Limitation Calculated by History (WELCH) questionnaire
timeFrame: pre and post-12 weeks
measure: Vascular quality of life questionnaire (VascuQoL-6)
timeFrame: pre and post-12 weeks
measure: EuroQoL questionnaire (EQ-5D-5L).
timeFrame: pre and post-12 weeks
measure: Short Form Dietary Questionnaire
timeFrame: pre and post-12 weeks
measure: Physical activity levels (Fitbit Charge HR)
timeFrame: pre and post-12 weeks
measure: Sleep
timeFrame: pre and post-12 weeks
measure: Alcohol and tobacco use
timeFrame: pre and post-12 weeks
measure: Mental wellbeing
timeFrame: pre and post-12 weeks
measure: Patient activation
timeFrame: pre and post-12 weeks
measure: Resource utilisation
timeFrame: pre and post-12 weeks
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital - Newcastle upon Tyne NHS trust
Study officials:
affiliation: Freeman Hospital - Newcastle upon Tyne NHS trust
name: James Prentis
role: PRINCIPAL_INVESTIGATOR
References: