Clinical trial NCT00873028: Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass
Official title: Inspiratory Muscle Strength as a Determinant of Functional Capacity Early After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Physical therapy
Inspiratory muscles
Exercise
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery.

Detailed description: Eligible patients were randomized to a cardiopulmonary rehabilitation program (Rehab; n = 10) or to usual care (Control; n = 10). The randomization was done by the Graphpad StatMate computerized program. Those patients assigned to Control were followed by their own physicians, received routine nursing assistance, were visited daily by the one of the investigators (CPM), but were not exposed to any specific respiratory or motor physical intervention. Those randomized to Rehab received the same medical and nursing care, but followed a structured physical therapy program twice a day.

Eligibility criteria: Inclusion Criteria:

* Previous history of more than one vessel coronary artery disease
* Lifelong abstinence from tobacco
* Formal indication for CABG

Exclusion Criteria:

* Patients older than 75 years of age
* Chronic renal failure (dialysis for more than 3 months)
* Unstable angina in the 48 hours prior to CABG
* Moderate or severe valve disease
* Complex cardiac arrhythmia's
* Stroke
* Inability to exercise the lower limbs
* Previous pulmonary disease (forced vital capacity \[FVC\] \< 80% of predicted and/or forced expiratory volume in 1 s \[FEV1\] \< 70% of predicted)
* Previous history of asthma.

Primary outcomes:
measure: Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery).
timeFrame: From 1 day before surgery up to 30 days after surgery (CABG)
Secondary outcomes:
measure: Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG.
timeFrame: From 7 days after surgery up to 30 days after surgery (CABG)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Ricardo Stein, MD.ScD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haeffener MP, Ferreira GM, Barreto SS, Arena R, Dall'Ago P. Incentive spirometry with expiratory positive airway pressure reduces pulmonary complications, improves pulmonary function and 6-minute walk distance in patients undergoing coronary artery bypass graft surgery. Am Heart J. 2008 Nov;156(5):900.e1-900.e8. doi: 10.1016/j.ahj.2008.08.006. Epub 2008 Oct 5.
citation: Hirschhorn AD, Richards D, Mungovan SF, Morris NR, Adams L. Supervised moderate intensity exercise improves distance walked at hospital discharge following coronary artery bypass graft surgery--a randomised controlled trial. Heart Lung Circ. 2008 Apr;17(2):129-38. doi: 10.1016/j.hlc.2007.09.004. Epub 2007 Dec 3.
citation: Dall'Ago P, Chiappa GR, Guths H, Stein R, Ribeiro JP. Inspiratory muscle training in patients with heart failure and inspiratory muscle weakness: a randomized trial. J Am Coll Cardiol. 2006 Feb 21;47(4):757-63. doi: 10.1016/j.jacc.2005.09.052. Epub 2006 Jan 26.
citation: Borghi-Silva A, Mendes RG, Costa Fde S, Di Lorenzo VA, Oliveira CR, Luzzi S. The influences of positive end expiratory pressure (PEEP) associated with physiotherapy intervention in phase I cardiac rehabilitation. Clinics (Sao Paulo). 2005 Dec;60(6):465-72. doi: 10.1590/s1807-59322005000600007. Epub 2005 Dec 12.
citation: Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 2008 Sep;87(9):714-9. doi: 10.1097/PHM.0b013e3181839152.