Cardiac Rehabilitation Program in Peripheral Arterial Disease

NCT03251391 | Completed

• 1 other identifier: STUDY00140692
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

revascularization; blocked arteries; leg arteries; leg pain

Outcome Measures

Primary Outcomes (1)

• Change in 6 minute walk test

  Results will be measured in meters.

  Change from Baseline to Up to 6 Months

Secondary Outcomes (6)

• Short Form Health Survey 36 (SF-36)

  Change from Baseline to Up to 6 Months

• Short Form Health Survey 36 (SF-36)

  Change from Baseline to Week 18

• Vascular Quality of Life Questionnaire-6 (VascuQol6)

  Change from Baseline to Up to 6 Months

• Vascular Quality of Life Questionnaire-6 (VascuQol6)

  Change from Baseline to Week 18

• Absolute Claudication Distance (ACD)

  Change from Baseline to Up to 6 Months

Study Arms (2)

Cardiac Rehabilitation Group

EXPERIMENTAL

Participants randomized to this group will undergo cardiac rehabilitation program.

Other: Cardiac Rehabilitation Program

Control Group

ACTIVE COMPARATOR

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

Other: Conventional Therapy

Interventions

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.

Cardiac Rehabilitation Group

Conventional Therapy OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Below or above the knee amputation.
• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Kamal Gupta, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 16, 2017
• Study Start: April 13, 2017
• Primary Completion: May 11, 2019
• Study Completion: May 11, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

US (1)