Effects a Rehabilitation Program in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
3 mei 2016 bijgewerkt door: Solange Guizilini, Federal University of São Paulo
Effects of Exercise Rehabilitation Program at Hospitalar Fase on Inflammatory Markers, Functional Capacity and Clinical Outcomes in Patients With Left Ventricular Dysfunction After Coronary Artery Bypass Grafting
This study aims to analyze effects of three types of cardiac rehabilitation protocol on fuctional capacity, inflammatory markers, pulmonary function and clinical outcomes after coronary artery bypass grafting (CABG) in patients with left ventricular disfunction.
Patients will be randomized and allocated in three groups according to type of exercise protocol: 1. walk; 2. cycle; 3. functional electrical stimulation.
Studie Overzicht
Toestand
Onbekend
Interventie / Behandeling
Gedetailleerde beschrijving
Several studies have been demonstrated beneficial effects of exercise to minimize impact of CABG. However, there is no consensus on what kind of exercise is safe and effective for patients with left ventricular dysfunction.
Walking
Studietype
Ingrijpend
Inschrijving (Verwacht)
45
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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SP
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Sao Paulo, SP, Brazilië, 04023062
- Werving
- Federal University of São Paulo
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Contact:
- Solange Guizilini, PhD
- Telefoonnummer: +5511982887753
- E-mail: s_guizilini@yahoo.com.br
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
35 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Coronary artery disease proven by coronary angiography;
- Elective CABG;
- No acute or chronic pulmonary disease;
- Patients after surgery, keep in spontaneous ventilation on first postoperative day;
- Absence of neurological, neuromuscular, musculoskeletal and osteoarticular incapacitating;
- Consent form signed for participation in the survey.
Exclusion Criteria:
- Inability to perform spirometry;
- Presence of acute lung disease or chronic;
- Surgical indication of urgency;
- Morbid obesity;
- Hemodynamics instability at the time of spirometry or during six minutes walking test;
- Intraoperative death or until the sixth postoperative day;
- Patients remaining in mechanical prolonged ventilation for more than 12 hours;
- Severe cardiac arrhythmia during application of assessment protocols and exercises (ventricular tachycardia, atrioventricular block second or degree) any other condition the investigator's discretion put the patient at increased risk with beginning of the year; Any change that may lead to failure of proposed protocols.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Walking exercise
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking.
The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
On first postoperative day, participants will perform exercises in supine position.
From the second to the fifth postoperative day, they will perform progressive walking.
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Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking.
The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
On first postoperative day, participants will perform exercises in supine position.
From the second to the fifth postoperative day, they will perform progressive walking.
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|
Experimenteel: Stationary cycling exercise
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs.
From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
|
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs.
From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
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Experimenteel: Neuromuscular electrical stimulation
Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs.
From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient.
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Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs.
From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Functional Capacity
Tijdsspanne: Up to ten days after surgery, at hospital discharge.
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Participants will be submitted to six minute walk test on preoperative period and sixth postoperative day (or before hospital discharge) to evaluate functional capacity.
The test will be performed with a mobile device to measure metabolic response to exercise (Oxycon™ Mobile).
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Up to ten days after surgery, at hospital discharge.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Inflammatory markers
Tijdsspanne: in-hospital postoperative period, up to ten days after surgery.
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Blood sample will be collected to measure inflammatory markers (TNF-alpha and interleukins) and to compare exercise effects on inflammatory response after surgery.
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in-hospital postoperative period, up to ten days after surgery.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Solange Guizilini, PhD, Federal University of São Paulo
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2014
Primaire voltooiing (Verwacht)
1 mei 2016
Studie voltooiing (Verwacht)
1 juni 2017
Studieregistratiedata
Eerst ingediend
13 april 2016
Eerst ingediend dat voldeed aan de QC-criteria
3 mei 2016
Eerst geplaatst (Schatting)
5 mei 2016
Updates van studierecords
Laatste update geplaatst (Schatting)
5 mei 2016
Laatste update ingediend die voldeed aan QC-criteria
3 mei 2016
Laatst geverifieerd
1 mei 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 31295914.0.0000.5505
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
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