Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Intermittent Claudication; Behavior, Health; Exercise Intervention
• Intervention / Treatment: Behavioral: Exercise and Lifestyle Change

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel Cucato, PhD; Phone Number: 0191 2448684; Email: gabriel.cucato@northumbria.ac.uk
• Study Contact Backup: Name: James Prentis; Phone Number: 0191 2448684; Email: james.prentis@nhs.net

Study Locations

• United Kingdom
  • Newcastle Upon Tyne, United Kingdom
    • Recruiting
    • Freeman Hospital - Newcastle upon Tyne NHS trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Outcomes	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	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Northumbria University
• Investigators: Principal Investigator: James Prentis, Freeman Hospital - Newcastle upon Tyne NHS trust

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): April 17, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 286735

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No