NCT05260567

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Northumbria University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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%.

Timeline

• Start date: 2022-02-05
• Primary completion: 2023-07-30
• Completion: 2023-11-08
• First posted: 2022-03-02
• Last updated: 2023-11-13

Locations

1 site across 1 country: United Kingdom