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Completed

NCT Number: NCT03251391

Cardiac Rehabilitation Program in Peripheral Arterial Disease

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation program

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.

Conventional Therapy

Other

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

Primary outcomes

  1. Change in 6 minute walk test

    Time frame: Change from Baseline to Up to 6 Months

    Results will be measured in meters.

Secondary outcomes

  1. Short Form Health Survey 36 (SF-36)

    Time frame: Change from Baseline to Up to 6 Months

    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.

  2. Short Form Health Survey 36 (SF-36)

    Time frame: 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.

  3. Vascular Quality of Life Questionnaire-6 (VascuQol6)

    Time frame: Change from Baseline to Up to 6 Months

    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.

  4. Vascular Quality of Life Questionnaire-6 (VascuQol6)

    Time frame: 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.

  5. Absolute Claudication Distance (ACD)

    Time frame: 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

  6. Functional Claudication Distance (FCD)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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