NCT03839953

Exercise Rehabilitation for Patients With Critical Limb Ischemia After Revascularization

Status unknown NA Last updated 28 May 2019

What this trial tests

NA trial testing Supervised Exercise Program in Peripheral Arterial Disease in 64 participants. Status unknown.

Timeline

15 February 2019

Primary endpoint
1 January 2020

1 July 2020

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	15 February 2019
Primary completion	1 January 2020
Estimated completion	1 July 2020
Sites	1 location across Canada

Drugs / interventions tested

• Supervised Exercise Program
• Best Medical Therapy — full drug profile →

Conditions studied

• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Critical Limb Ischemia — all drugs for Critical Limb Ischemia →

Sponsor

University of Calgary

Who can join

18 and older, any sex, with Peripheral Arterial Disease or Critical Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Peripheral arterial disease (PAD) affects more than 200 million people worldwide. This disease occurs with narrowing and occlusion of arteries supplying oxygenated blood to the organs and limbs. Symptomatic patients typically experience leg pain with physical activity. More advanced disease states are referred to as critical limb ischemia (CLI), where patients may have leg pain at rest or non-healing wounds. Primary treatment of PAD involves risk factor management; smoking cessation, management of blood pressure, blood cholesterol, diabetes, and exercise prescription. Patients with CLI typically require interventions to reestablish blood supply to their limbs. There is currently minimal understanding of the role for exercise rehabilitation after revascularization procedures in this vulnerable population. This is the first clinical to understand the role of exercise for these patients. We hypothesize that exercise rehabilitation after revascularization will improve quality of life and functional capacity in these patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A systematic review of patient-reported outcome measures patients with chronic limb-threatening ischemia.
   Goodney P, Shah S, Hu YD, Suckow B, et al · · 2022 · cited 23× · PMID 35085747 · DOI 10.1016/j.jvs.2021.11.057