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Completed

NCT Number: NCT02742350

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, 90130051, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IMT - POWERbreathe Plus Light Resistance®, SP, BR

Device

POWERbreathe Plus Light Resistance®, SP, BR

Primary outcomes

  1. Six-minute walk test

    Time frame: 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 outcomes

  1. 30-s chair-stand

    Time frame: 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

    Time frame: 1 week, up to 4 week, up to 8 week, through study completion, an average of 12 week

  3. Quality of life

    Time frame: 1 week, through study completion, an average of 12 week

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

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2016
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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