Cardiac Rehabilitation Program in Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Other: Conventional Therapy; Other: Cardiac Rehabilitation Program

• Registration Number: NCT03251391
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-13
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Primary Completion: 2019-05-11
• Study Completion: 2019-05-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in 6 minute walk test	Change from Baseline to Up to 6 Months	Results will be measured in meters.

Secondary Outcome Measures

Name	Time	Method
Short Form Health Survey 36 (SF-36)	Change from Baseline to Week 18	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.
Vascular Quality of Life Questionnaire-6 (VascuQol6)	Change from Baseline to Week 18	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.
Absolute Claudication Distance (ACD)	Change from Baseline to Up to 6 Months	ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain. Distance is measured in meters
Functional Claudication Distance (FCD)	Change from Baseline to Up to 6 Months	FCD is defined as the distance a patient would prefer to stop because of claudication pain. Distance is measured in meters.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States