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Cycle Ergometer Exercise in Phase I of Cardiac Rehabilitation After Cardiac Surgery

2021년 1월 28일 업데이트: Ada Clarice Gastaldi, University of Sao Paulo
The prevalence of heart diseases has increased significantly in recent years and it is a health public problem due to an increased risk of death by several reasons. A cardiac surgery is an alternative of treatment for critical injuries heart valves and coronaries arteries. Changes in respiratory system resulting from cardiac surgery are well established and include a reduced functional capacity due post-surgical pain, causing increased respiratory function and increased oxygen consumption . The exercises with the cycle ergometer in phase I of cardiac rehabilitation can improve peripheral muscle strength, functional capacity and perception of dyspnea when used postoperatively and there are speculations if an earlier carried out can contribute to a better postoperative evolution of patients, but these benefits in phase I of the Rehabilitation Cardiac are not well defined in the literature. Objective: To evaluate the exercises effects with ergometer cycle in the postoperative course of patients undergoing cardiac surgery. Method: Patients will be recruited the cardiac surgery service of Polyclinic Pato Branco in the city of Pato Branco in state of Paraná, of both sexes, appropriate for the inclusion criteria, which will be evaluated by pulmonary function tests (strength of respiratory muscles, submaximal exercise test, dyspnea scales, laboratories tests and radiological exam). All patients will be randomly assigned for one of two groups: the control group (Conventional treatment) and rehabilitation group (conventional treatment +cycle ergometer), for about 7 days at postoperative period. Patients will be reevaluated on the third postoperative day and at discharge. Clinical evolution data will be collected from the records and notes of the medical staff and monitoring physiotherapist.

연구 개요

상태

빼는

정황

개입 / 치료

상세 설명

The research will be a randomized controlled clinical trial. The study will be conducted at the Polyclinic Pato Branco, in the city of Pato Branco Parana - Brazil and this study already approved by the Ethics Committee Clinical Hospital and Faculty of Medicine, University of São Paulo and all participants sign the consent form informed. For the implementation of research wil be recruited patients heart surgery who fit the inclusion criteria and do not show any characteristics of the exclusion criteria, which agree to participate and sign the consent form free and informed. The equipment and tests are already included in routine admissions of patients, approved by the hospital and the Brazilian Public Health System (SUS).

연구 유형

중재적

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 브라질
    • Paraná
      • Pato Branco, Paraná, 브라질, 85501250
        • Policlínica Pato Branco

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

30년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patients undergoing cardiac surgery type Myocardial Revascularization and Exchange Mitral Valve Aortic, both sexes and aged between 30-75 years.

Exclusion Criteria:

  • Patients undergoing surgical correction of heart disease congenital, aortic aneurysm and dissection of aorta;

    • Present disabling disease to accomplish what is proposed in study as previous stroke, mental or motor deficit, hearing loss, amputation of the lower limbs (unilateral or bilateral);
    • Present psychomotor agitation of immediate postoperative and first postoperative and history weaning failure in the immediate;
    • Instability hemodynamics and vasoactive drugs;
    • Present what other type of peri and postoperative complications;
    • Re-operation within 24 hrs.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Control group: routine physiotherapy
Are patients who carry out the routine already established the Unit, consisting of the first post surgery, the patient lying down doing the breathing exercises, active exercises ends and active-assisted upper (UL) and lower limbs (LL),
다른: routine physiotherapy
routine physiotherapy
활성 비교기: Intervention group: ergometer cycle exercise
Are the patients who will carry out the exercises routine over the cycle ergometer twice daily from 3 PO for 5 minutes with its progressiveness at discharge for ward for 10 minutes
다른: routine physiotherapy
routine physiotherapy
장치: ergometer cycle exercise

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change of six-minute walk test (6MMWT) distance
기간: Before surgery ,third and seventh postoperative day
The six-minute walk test will be conducted with monitoring blood pressure, HR, RR and SpO2 in a hall plan, with distances previously marked. The patient will be accompanied by the researcher and encouraged by constant verbal stimulation, walking as fast as possible, if the patient stop walking the timer will keep triggered. Will use the oximeter with the sensor on the third finger of the right hand, and a certain reading after the signal stabilization and at the same time we get the heart rate. Will be used to calculate the expected value, and reference to distance in the 6MWT, the equations proposed by Enright and Sherrill (1998) determining the percentage of predicted for each test performed by patient.
Before surgery ,third and seventh postoperative day

2차 결과 측정

결과 측정
측정값 설명
기간
Change of spirometric values
기간: Before surgery ,third and seventh postoperative day
Spirometry will be performed according to criteria of the American Thoracic Society and the Brazilian Consensus Spirometry. Values will be observed from CVF, VEF1 e PEF.
Before surgery ,third and seventh postoperative day

기타 결과 측정

결과 측정
측정값 설명
기간
Change of respiratory muscle strength - Mouth pressure measurements
기간: Before surgery ,third and seventh postoperative day
Manovacuometry will be performed with the patient seated with nasal clip, the display scale with intervals of 4 cmH2O and variation +/- 120 cmH2O. The highest value obtained during the two maneuvers will be compared to the table described by Neder et al (1999), which predicts expected values for the Brazilian population according to gender and age.
Before surgery ,third and seventh postoperative day
Change of perceived dyspnea
기간: Before surgery ,third and seventh postoperative day
The perceived effort is used the Borg Scale modified scored from 0 to 10. And dyspnea scale will be scored from 0 to 4 according to the intensity of dyspnea and is based on used the scale of the Medical Research Council (MRC).
Before surgery ,third and seventh postoperative day
Change of body mass index
기간: Before surgery and postoperative seventh day
The BMI will be calculated using the classical formula: BMI = current weight (kg) / A2 (m). The following lower limits of normal were considered: BMI <21 for age group 35-44 years; <22 for 45-54 years; <23 for 55 -64 years and <24 to 65 above years.
Before surgery and postoperative seventh day
Change of cirtometry
기간: Before surgery ,third and seventh posoperative day
Cirtometry will be held in myocardial revascularization of patients who use the saphenous and waist hip will be performed in all patients. Will be used a tape measure.
Before surgery ,third and seventh posoperative day
Change of peripheral muscle strength
기간: Before surgery ,third and seventh postoperative day
The peripheral muscle strength assessment test will be the end of the test the foot, the patient will be instructed to stay barefoot with his right hand resting on the front wall and with a semi elbow flexion to aid maintenance balance. Prior to testing, the participant will be oriented make a plantar flexion to the point of support of the joints metatarsophalangeal and this time will be marked by the examiner through a mark on the wall and the patient will be informed that should reach the one marked point. The test itself consisted of time, in seconds, the time it takes to perform five push-ups as plantar soon as possible.
Before surgery ,third and seventh postoperative day
Change in cortisol levels
기간: Before surgery ,third and seventh postoperative day
Laboratory evaluation will be performed by laboratory staff of hospital with a blood sample from the patient, which will be assessed the cortisol levels .
Before surgery ,third and seventh postoperative day
change of radiological assessment
기간: Before surgery ,third and seventh postoperative day
Radiological assessment will be held the day before the surgery, the third post-operative and post-operative seventh, the clinic Radiology Southwest - Pato Branco - Paraná to assess complications lung from surgery.
Before surgery ,third and seventh postoperative day
Adherence evaluation
기간: Third and seventh postoperative day
The questionnaire will be administered at the end of the first contact of the patient the exercises with the cycle ergometer to assess adherence running a differential exercise during your surgical recovery.
Third and seventh postoperative day

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Sao Paulo

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

기본 완료 (실제)

2021년 1월 28일

연구 등록 날짜

최초 제출

2015년 4월 29일

QC 기준을 충족하는 최초 제출

2015년 5월 6일

처음 게시됨 (추정)

2015년 5월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 1월 28일

마지막으로 확인됨

2021년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • USP 2015-1

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심장 수술에 대한 임상 시험

routine physiotherapy에 대한 임상 시험

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