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Inspiratory Muscular Training

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training
Control group
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, respiratory muscles, optoelectronic plethysmography

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • sedentary adults diagnosed with functional class II and II CHF in accordance with the New York Heart Association (NYHA);
  • in stage B or C according to American College of Sports Medicine guidelines;
  • with left ventricle ejection fraction lower than 45% (evaluated by echocardiogram in a period ≤ 1 year);
  • cardiomegaly confirmed by increased left ventricle end-diastolic (LVDD) and end-systolic diameter (LVESD) associated with a cardiac index (CI) >0.5 according to chest X-rays;
  • inspiratory muscle weakness (MIP <70% of predicted values);
  • clinical stability with no change in medication for at least three months and sedentary (no regular physical activity performed in the previous six months or not accumulating 30 minutes or more of moderate physical activity - 3 to 6 METs - on most week days).

Exclusion Criteria:

  • patients exhibiting unstable angina, myocardial infarction or prior heart surgery up to three months before beginning the investigation;
  • orthopedic, infectious or chronic metabolic diseases;
  • treatment with steroids, hormones or chemotherapy;
  • ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC) < 70% of predicted, characterizing an obstructive respiratory disorder;
  • respiratory diseases, smokers and ex-smokers with a history of cigarettes/day for more than 10 years.

Sites / Locations

  • Departamento de Fisioterapia-Universidade Federal de pernambuco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory Muscle Training

Control group

Arm Description

Inspiratory Muscle Training

Patients from the control group were also assessed weekly to ensure homogenization of the learning effect for the manometer maneuver.

Outcomes

Primary Outcome Measures

Respiratory muscles
In order to evaluate inspiratory muscle strength, a digital manometer was used (MVD-300, Globalmed, Brazil) connected to a mouthpiece with a 2mm opening to reduce the influence of pressure caused by glottal closure. In a sitting position, each patient performed up to six maneuvers to obtain MIP, from residual volume (RV) to total functional capacity (TFC), considering the best of three maneuvers with < 10% variation between them

Secondary Outcome Measures

Assessment of respiratory mechanics by Optoelectronic Plethysmography
The optoelectronic plethysmography system (OEP) of BTS Bioengineering (Italy) was employed in this study. To that end, a calibration instrument was used, containing three axes connected to reflective markers. This phase does not require participation by the individual to be examined. This creates a three-dimensional model, dividing the thoracoabdominal system into three parts: pulmonary rib cage (RCp), abdominal rib cage (RCa) and the abdomen (AB).
Evaluation of submaximal functional capacity
Functional capacity was assessed by the six-minute walk test (6MWT), according to the protocol published by the American Thoracic Society (ATS).
Quality of Life Questionnaire: Minnesota Living With Heart Failure Questionnaire (MLHFQ)
The MLHFQ is a questionnaire validated for the Brazilian population, consisting of 21 questions regarding limitations frequently associated with the extent to which heart failure has affected patient's lives in the previous month. Each question is attributed a value from 0 (zero) to 5 (five), with the highest score indicating worse quality of life. The total score is calculated by adding the 21 items, with a possible interval between 0 and 105.

Full Information

First Posted
May 3, 2012
Last Updated
June 12, 2012
Sponsor
Universidade Federal de Pernambuco
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01593007
Brief Title
Inspiratory Muscular Training
Official Title
REGIONAL LUNG VENTILATION DISTRIBUTION AMONG INDIVIDUALS WITH CHRONIC HEART FAILURE AFTER AN INSPIRATORY MUSCLE TRAINING PROGRAMM: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives: To evaluate regional lung ventilation distribution in patients suffering from chronic heart failure (CHF) after completing inspiratory muscle training (IMT) and correlate it with functional capacity and quality of life among these individuals. Methods and Results: Nineteen CHF patients were randomly assigned to two groups: Control and IMT. Before and after muscle training, subjects were submitted to assessment protocol for respiratory muscles, digital spirometry, optoelectronic plethysmography (OEP), the six-minute walk test (6MWT) and a quality of life questionnaire (MLHFQ). There was no difference in lung function following the 12-week training period in either group. However, the IMT group showed an increase in actual and predicted MIP, higher MLFHQ score and greater distance walked in the 6MWT, as well as a reduction in the Borg scale after the 6 MWT in relation to the control. For the OEP, IMT group members exhibited higher values for total chest wall volume (Vcw), abdominal rib cage volume (Vrc,a) and abdominal volume (Vab) when compared to the control. Conclusions: For patients with CHF, IMT proved efficient in improving muscle strength, functional capacity and quality of life. The present study also analyzed the distribution behavior of lung volumes for the thoracoabdominal system in this population, showing that larger abdominal rib cage and abdomen volumes may result in more effective diaphragmatic contraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, respiratory muscles, optoelectronic plethysmography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
Inspiratory Muscle Training
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients from the control group were also assessed weekly to ensure homogenization of the learning effect for the manometer maneuver.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
All participants were instructed to use a Threshold® trainer for 30min a day, seven times a week over 12 consecutive weeks.10 Patients in the Control Group used a Threshold ® device without resistance, making them blind to the treatment. For the treatment group, inspiratory resistance of the Threshold® trainer was 30% of MIP, adjusted on a weekly basis to remain constant.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Patients from the control group were also assessed weekly to ensure homogenization of the learning effect for the manometer maneuver.
Primary Outcome Measure Information:
Title
Respiratory muscles
Description
In order to evaluate inspiratory muscle strength, a digital manometer was used (MVD-300, Globalmed, Brazil) connected to a mouthpiece with a 2mm opening to reduce the influence of pressure caused by glottal closure. In a sitting position, each patient performed up to six maneuvers to obtain MIP, from residual volume (RV) to total functional capacity (TFC), considering the best of three maneuvers with < 10% variation between them
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assessment of respiratory mechanics by Optoelectronic Plethysmography
Description
The optoelectronic plethysmography system (OEP) of BTS Bioengineering (Italy) was employed in this study. To that end, a calibration instrument was used, containing three axes connected to reflective markers. This phase does not require participation by the individual to be examined. This creates a three-dimensional model, dividing the thoracoabdominal system into three parts: pulmonary rib cage (RCp), abdominal rib cage (RCa) and the abdomen (AB).
Time Frame
3 months
Title
Evaluation of submaximal functional capacity
Description
Functional capacity was assessed by the six-minute walk test (6MWT), according to the protocol published by the American Thoracic Society (ATS).
Time Frame
3 mounths
Title
Quality of Life Questionnaire: Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Description
The MLHFQ is a questionnaire validated for the Brazilian population, consisting of 21 questions regarding limitations frequently associated with the extent to which heart failure has affected patient's lives in the previous month. Each question is attributed a value from 0 (zero) to 5 (five), with the highest score indicating worse quality of life. The total score is calculated by adding the 21 items, with a possible interval between 0 and 105.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: sedentary adults diagnosed with functional class II and II CHF in accordance with the New York Heart Association (NYHA); in stage B or C according to American College of Sports Medicine guidelines; with left ventricle ejection fraction lower than 45% (evaluated by echocardiogram in a period ≤ 1 year); cardiomegaly confirmed by increased left ventricle end-diastolic (LVDD) and end-systolic diameter (LVESD) associated with a cardiac index (CI) >0.5 according to chest X-rays; inspiratory muscle weakness (MIP <70% of predicted values); clinical stability with no change in medication for at least three months and sedentary (no regular physical activity performed in the previous six months or not accumulating 30 minutes or more of moderate physical activity - 3 to 6 METs - on most week days). Exclusion Criteria: patients exhibiting unstable angina, myocardial infarction or prior heart surgery up to three months before beginning the investigation; orthopedic, infectious or chronic metabolic diseases; treatment with steroids, hormones or chemotherapy; ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC) < 70% of predicted, characterizing an obstructive respiratory disorder; respiratory diseases, smokers and ex-smokers with a history of cigarettes/day for more than 10 years.
Facility Information:
Facility Name
Departamento de Fisioterapia-Universidade Federal de pernambuco
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18436118
Citation
Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71. doi: 10.1016/j.jacc.2007.12.045.
Results Reference
result
PubMed Identifier
17395049
Citation
Olson TP, Beck KC, Johnson BD. Pulmonary function changes associated with cardiomegaly in chronic heart failure. J Card Fail. 2007 Mar;13(2):100-7. doi: 10.1016/j.cardfail.2006.10.018.
Results Reference
result

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Inspiratory Muscular Training

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