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Cardiac Rehabilitation Program in Peripheral Arterial Disease

University of Kansas logo

University of Kansas

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Other: Cardiac Rehabilitation Program
Other: Conventional Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03251391
STUDY00140692

Details and patient eligibility

About

The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with PAD post-revascularization (stent, angioplasty, or bypass).
  • Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.

Exclusion criteria

  • Below or above the knee amputation.
  • Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
  • Unfavorable short term prognosis and limited life expectancy (<2 years)
  • Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
  • Prior history of having dropped out of CR without completing.
  • Unwilling to consent for all aspects of CR or study participation.
  • Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility).
  • Pregnancy

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

Cardiac Rehabilitation Group
Experimental group
Description:
Participants randomized to this group will undergo cardiac rehabilitation program.
Treatment:
Other: Cardiac Rehabilitation Program
Control Group
Active Comparator group
Description:
Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.
Treatment:
Other: Conventional Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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