Cardiac Rehabilitation Program in Peripheral Arterial Disease

To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Cardiac Rehabilitation Program; Other: Conventional Therapy

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Rehabilitation Group; Participants randomized to this group will undergo cardiac rehabilitation program.	Other: 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.
Active Comparator: Control Group; Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.	Other: Conventional Therapy; Participants will be asked to complete tests and questionnaires that would normally be done for their condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 minute walk test	Results will be measured in meters.	Change from Baseline to Up to 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form Health Survey 36 (SF-36)	Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.	Change from Baseline to Up to 6 Months
Short Form Health Survey 36 (SF-36)	Change in quality of life measured using the SF-36. The survey has 36 questions and measure eight health dimensions. The scores range from 0-100. A higher score represents less disability. A lower score represents more disability.	Change from Baseline to Week 18
Vascular Quality of Life Questionnaire-6 (VascuQol6)	The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.	Change from Baseline to Up to 6 Months
Vascular Quality of Life Questionnaire-6 (VascuQol6)	The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.	Change from Baseline to Week 18
Absolute Claudication Distance (ACD)	ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters	Change from Baseline to Up to 6 Months
Functional Claudication Distance (FCD)	FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.	Change from Baseline to Up to 6 Months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Kamal Gupta, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2017
• Primary Completion (Actual): May 11, 2019
• Study Completion (Actual): May 11, 2019

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: leg pain; revascularization; blocked arteries; leg arteries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STUDY00140692

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No