ower limb rehabilitation for patients with peripheral artery disease.

Not Applicable

• Conditions: Peripheral Artery Disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000744853
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-11
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) aged >=18 years.
2) a diagnosis of lower limb PAD established by a medical practitioner.
3) clinically stable PAD (i.e. stable intermittent claudication for at least 3 months not requiring revascularisation).
4) ability to walk.
5) community-dwelling (i.e. not residing in a nursing home or hostel).
6) able to consent to participate in the study.
7) competent in English at a level sufficient for study participation unless a translator is available.
8) able to participate in the study and comply with the study requirements over 6 months.

Exclusion Criteria

1) persons who are already enrolled in another study and/or;
2) an absolute or relative contraindication to participate in, or successfully complete, an exercise-based rehabilitation program, including:
i) women who are pregnant
ii) participants with lower limb pain at rest due to PAD
iii) those with tissue loss or gangrene due to PAD
iv) unstable heart disease
v) severe heart failure or other severe heart condition
vi) unstable aneurysm or ballooning of artery as diagnosed by a medical specialist
vii) rapidly progressive or terminal illness
viii) severe memory problems due to dementia
ix) severe psychosis or psychological illness
x) current active substance (drug or alcohol) abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be feasibility of the lower limb rehabilitation program, which will be measured as the percentage of PAD patients referred who attend and complete the program as compared with the reference standard for cardiac rehabilitation. A positive result will be defined as >=80% of eligible PAD patients approached accepting a referral and >=65% completing the 8-week program with an attendance (adherence) rate of >=80%. This will be performed by conducting an audit of the participants records, obtained during the supervised exercise sessions. [At the conclusion of the study.]