Effect of a novel exercise and behavioural support tele-health program for participants with peripheral artery disease related walking impairment.

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12622001566729
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-19
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

1. PAD diagnosed by a specialist based on current guidelines including PAD symptoms, absence of lower limb pulses or resting ABPI <0.9 or >1.4, or imaging evidence of lower limb arterial stenosis or occlusion

2. Able to walk independently, with or without walking aids

3. No currently planned peripheral revascularization

4. Complete study induction and safety check successfully.

Exclusion Criteria

1. Severe PAD, e.g. rest pain or gangrene, requiring urgent peripheral revascularisation;
2. Previous major lower limb amputation
3. Patient is deemed unsafe to undertake exercise because of an uncontrolled cardiac, metabolic or musculoskeletal problem or any other condition that may be exacerbated by exercising
4. A condition that requires high level medical care such as, but not limited to, renal dialysis or regular cancer treatment that impacts ability to complete regular exercise sessions
5. Unable to engage with Tele-artery (e.g. uncorrected blindness, deafness or mental impairment)
6. Terminal illness with prognosis of less than six months or involvement in another trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum walking distance during a six minute walk test[ Baseline and 6 months post-randomisation]