Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD

NCT ID: NCT05260567

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-05
• Study Completion Date: 2023-11-08

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise and Lifestyle Change

Exercise training and lifestyle change

Group Type: EXPERIMENTAL

Exercise and Lifestyle Change

Intervention Type: BEHAVIORAL

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%.

Standard Care

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

Group Type: OTHER

Exercise and Lifestyle Change

Intervention Type: BEHAVIORAL

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%.

Interventions

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%.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Cucato

Vice Chancellor Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Prentis

Role: PRINCIPAL_INVESTIGATOR

Freeman Hospital - Newcastle upon Tyne NHS trust

Locations

Freeman Hospital - Newcastle upon Tyne NHS trust

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Other Identifiers

286735

Identifier Type: -

Identifier Source: org_study_id