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Prehabilitation for PAD Revascularization Patients

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University of Michigan

Status

Terminated

Conditions

Peripheral Artery Disease
Peripheral Vascular Disease

Treatments

Behavioral: Prehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT02767895
HUM00113096

Details and patient eligibility

About

Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.

Full description

Patients undergoing elective revascularization for their peripheral artery disease will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.

Enrollment

7 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Documented lower extremity PAD
  • Ability to walk at least 1 block
  • Sedentary
  • Medical clearance from the surgical team
  • Competent to provide consent

Exclusion criteria

  • Life expectancy < 6 months
  • Co-morbidities which limit walking to a severe degree
  • Signs of critical limb ischemia
  • Recent or current enrollment in a formal exercise program
  • Recent cardiovascular events including stroke, TIA, severe valve disease, etc.
  • Current substance abuse
  • Psychiatric disorder which limits ability to participate in study procedures
  • Non-English speaking

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

7 participants in 2 patient groups

Prehabilitation
Experimental group
Description:
Participants will be referred to the Michigan Surgical \& Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health
Treatment:
Behavioral: Prehabilitation
Usual Care
No Intervention group
Description:
Participants will follow the pre-operative instructions provided by their surgical team.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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