Cardiac Rehabilitation Program in Peripheral Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-13

Study Completion Date

2019-05-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cardiac Rehabilitation Group

Participants randomized to this group will undergo cardiac rehabilitation program.

Group Type EXPERIMENTAL

Cardiac Rehabilitation Program

Intervention Type OTHER

Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months.

Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.

Control Group

Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type OTHER

Participants will be asked to complete tests and questionnaires that would normally be done for their condition.

Interventions

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Cardiac Rehabilitation Program

Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months.

Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information.

Intervention Type OTHER

Conventional Therapy

Participants will be asked to complete tests and questionnaires that would normally be done for their condition.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No