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Completed

NCT Number: NCT05260567

Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Behavior, Health Cardiovascular Diseases Exercise Intervention Health Behavior Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Freeman Hospital - Newcastle upon Tyne NHS trust

Newcastle upon Tyne, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and Lifestyle Change

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%.

Primary outcomes

  1. Feasibility of the program

    Time frame: post 12 weeks

    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)

  2. Acceptability of the program

    Time frame: post 12 weeks

    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.

Secondary outcomes

  1. Six-minute walk test (6MWT)

    Time frame: pre and post-12 weeks

  2. Walking Impairment Questionnaire (WIQ)

    Time frame: pre and post-12 weeks

  3. Walking Estimated Limitation Calculated by History (WELCH) questionnaire

    Time frame: pre and post-12 weeks

  4. Vascular quality of life questionnaire (VascuQoL-6)

    Time frame: pre and post-12 weeks

  5. EuroQoL questionnaire (EQ-5D-5L).

    Time frame: pre and post-12 weeks

  6. Short Form Dietary Questionnaire

    Time frame: pre and post-12 weeks

  7. Physical activity levels (Fitbit Charge HR)

    Time frame: pre and post-12 weeks

  8. Sleep

    Time frame: pre and post-12 weeks

    (Fitbit Charge HR)

  9. Alcohol and tobacco use

    Time frame: pre and post-12 weeks

    The 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and self-reported smoking habits

  10. Mental wellbeing

    Time frame: pre and post-12 weeks

    hospital anxiety-depression score (HADS)

  11. Patient activation

    Time frame: pre and post-12 weeks

    The Patient Activation Measure (PAM®)

  12. Resource utilisation

    Time frame: pre and post-12 weeks

    The case report forms (CRF)

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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