Effects of Muscle Trainins Inspiratory Linked to Cardiac Rehabilitation Post-operative of CABG Surgery

Sponsor
Federal University of Health Science of Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT02742350
Collaborator
(none)
20
1
2
15.7
1.3

Study Details

Study Description

Brief Summary

Heart surgery procedures are still widely used worldwide for the treatment of patients with heart problems, and rates of complications in the postoperative period related to them remain high. In these patients, physical conditioning programs result in improved functional capacity, and reducing the heart rate and systolic blood pressure. The inspiratory muscle training is also emerging as a valuable strategy in the treatment of cardiac patients. The study of the interaction between cardiac rehabilitation and high intensity IMT about these changes is not yet understood in this population. The aim of this study is to assess the effects of inspiratory muscle training high intensity associated with cardiac rehabilitation exercise performance of patients in the postoperative period of CABG surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: IMT - POWERbreathe Plus Light Resistance®, SP, BR
N/A

Detailed Description

It is a controlled, randomized clinical trial in which patients were randomly assigned randomly after referral to cardiac rehabilitation: Group 1 IMT-HI, group 2 - IMT-HI control. The evaluator of outcomes is blinded as to groups. The study protocol lasts 36 sessions for both groups. The group 1 patients performs cardiac rehabilitation protocol for 40 minutes with cardio and stretching and also inspiratory muscle training protocol of high intensity with 50% load increase in maximal inspiratory pressure during the first two weeks, 60% of MIP in third and fourth week, 70% of MIP in the fifth and sixth week and 80% MIP in the seventh and eighth week. The group 2 patients only perform the cardiac rehabilitation protocol for 40 minutes with aerobic exercise and stretching.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Inspiratory Muscle Training Hihg Intensity Linked to Cardiac Rehabilitation in Patients on Exercise Performance in the Post-operative of Coronary Artery Bypasssurgery: a Randomized Clinical Trial
Actual Study Start Date :
Sep 10, 2015
Actual Primary Completion Date :
Sep 30, 2016
Actual Study Completion Date :
Dec 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: IMT+Exercise

The inspiratory muscle training protocol (IMT) high intensity is achieved with a device with linear load pressure (POWERbreathe Plus Light Resistance®, SP, BR) that allows loads up to -90cmH2O. IMT is performed for 36 sessions (12 weeks) with weekly frequency of three times a week under supervision prior to the cardiac rehabilitation. The training protocol consists of five series with 10 repetitions each set until the 8th week with increase in the number of sets of repetitions of the 8th to 12th week, with two minutes or according to patient feedback using the modified Borg scale . Aerobic training lasts 40 minutes (5 minutes heating 30 minute workout and 5 minutes desaqueciemento. During training vital signs such as heart rate, blood pressure (BP) and peripheral oxygen saturation (SpO2) are evaluated and the feeling of effort the patient should not exceed the level of 8 according to the modified Borg scale.

Device: IMT - POWERbreathe Plus Light Resistance®, SP, BR
POWERbreathe Plus Light Resistance®, SP, BR

No Intervention: Exercise Control

Aerobic Exercise and Stretching

Outcome Measures

Primary Outcome Measures

  1. Six-minute walk test [1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week]

    The patient is set to walk in a corridor of 30 meters delimited cones for six minutes in order to go as far as possible. Every minute the patient is stimulated by the evaluator.

Secondary Outcome Measures

  1. 30-s chair-stand [1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week]

    With the patient sitting in a chair with 45cm tall, with your feet apart and flat on the floor and arms crossed against his chest, the patient will be encouraged to get up and return to a sitting position as many times as possible in 30 seconds, It is registered the maximum number of repetitions.

  2. respiratory muscle strength test [1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week]

  3. Quality of life [1 week, through study completion, an average of 12 week]

    Brazilian version of the Quality of Life Questionnaire - SF-36

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients in the postoperative period of elective CABG

  • Between the fourteenth and the thirtieth day after surgery

  • Between 30 and 70 years old

Exclusion Criteria:
  • Decompensated heart failure

  • Unstable angina

  • Moderate respiratory disease severe

  • Active infectious disease or fever

  • Disabling peripheral vascular disease

  • Unstable ventricular arrhythmias

  • Use of cardiac pacemaker.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rodrigo Della Méa Plentz Porto Alegre RS Brazil 90130051

Sponsors and Collaborators

  • Federal University of Health Science of Porto Alegre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rodrigo Della Méa Plentz, Clinical Professor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:
NCT02742350
Other Study ID Numbers:
  • IMT+exercise-CABG
First Posted:
Apr 19, 2016
Last Update Posted:
Apr 28, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2017