Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260567
• Other study ID #: 286735
• Status: Completed
• Phase: N/A
• Start date: February 5, 2022
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 8, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Health
• Exercise Intervention
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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%.

Locations

Country	Name	City	State
United Kingdom	Freeman Hospital - Newcastle upon Tyne NHS trust	Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the program	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
Primary	Acceptability of the program	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	Six-minute walk test (6MWT)		pre and post-12 weeks
Secondary	Walking Impairment Questionnaire (WIQ)		pre and post-12 weeks
Secondary	Walking Estimated Limitation Calculated by History (WELCH) questionnaire		pre and post-12 weeks
Secondary	Vascular quality of life questionnaire (VascuQoL-6)		pre and post-12 weeks
Secondary	EuroQoL questionnaire (EQ-5D-5L).		pre and post-12 weeks
Secondary	Short Form Dietary Questionnaire		pre and post-12 weeks
Secondary	Physical activity levels (Fitbit Charge HR)		pre and post-12 weeks
Secondary	Sleep	(Fitbit Charge HR)	pre and post-12 weeks
Secondary	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
Secondary	Mental wellbeing	hospital anxiety-depression score (HADS)	pre and post-12 weeks
Secondary	Patient activation	The Patient Activation Measure (PAM®)	pre and post-12 weeks
Secondary	Resource utilisation	The case report forms (CRF)	pre and post-12 weeks