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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cardiac Rehabilitation Group
Participants randomized to this group will undergo cardiac rehabilitation program.
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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. |
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활성 비교기: Control Group
Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.
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Participants will be asked to complete tests and questionnaires that would normally be done for their condition.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in 6 minute walk test
기간: Change from Baseline to Up to 6 Months
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Results will be measured in meters.
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Change from Baseline to Up to 6 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Short Form Health Survey 36 (SF-36)
기간: Change from Baseline to Up to 6 Months
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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.
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Change from Baseline to Up to 6 Months
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Short Form Health Survey 36 (SF-36)
기간: Change from Baseline to Week 18
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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.
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Change from Baseline to Week 18
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Vascular Quality of Life Questionnaire-6 (VascuQol6)
기간: Change from Baseline to Up to 6 Months
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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
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Vascular Quality of Life Questionnaire-6 (VascuQol6)
기간: Change from Baseline to Week 18
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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
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Absolute Claudication Distance (ACD)
기간: Change from Baseline to Up to 6 Months
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ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain.
Distance is measured in meters
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Change from Baseline to Up to 6 Months
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Functional Claudication Distance (FCD)
기간: Change from Baseline to Up to 6 Months
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FCD is defined as the distance a patient would prefer to stop because of claudication pain.
Distance is measured in meters.
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Change from Baseline to Up to 6 Months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kamal Gupta, MD, University of Kansas Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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