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Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

In Hospital Cardiopulmonary Rehabilitation

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Physical therapy, Inspiratory muscles, Exercise

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery).

Secondary Outcome Measures

Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG.

Full Information

NCT ID

NCT00873028

First Posted

March 30, 2009

Last Updated

March 31, 2009

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT00873028

Brief Title

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

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Physical therapy, Inspiratory muscles, Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

In Hospital Cardiopulmonary Rehabilitation

Other Intervention Name(s)

Cardiac rehabilitation, Phase one cardiac rehabilitation

Intervention Description

The program consisted of bronchial hygiene characterized by detachment and removal of secretions and respiratory exercises which were applied in the respiratory muscles in order to strengthen and increase the resistance. Patients were instructed to maintain diaphragmatic breathing, at a rate of 12 to 18 breaths per minute during EPAP mask use, and the expiratory pressure was increased progressively in the following fashion: 3-8 cm H2O during 3-12 minutes. Also, they performed flexion/extension of hip and knee, active free exercises for upper limbs, ambulation exercise and ascent/descend of stairs

Primary Outcome Measure Information:

Title

Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery).

Time Frame

From 1 day before surgery up to 30 days after surgery (CABG)

Secondary Outcome Measure Information:

Title

Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG.

Time Frame

From 7 days after surgery up to 30 days after surgery (CABG)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ricardo Stein, MD.ScD.

Organizational Affiliation

Hospital de Clinicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clinicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

900035-903

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

19061704

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.

Results Reference

result

PubMed Identifier

18060837

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.

Results Reference

result

PubMed Identifier

16487841

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.

Results Reference

result

PubMed Identifier

16358136

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.

Results Reference

result

PubMed Identifier

18716482

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.

Results Reference

result

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Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass

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