Inspiratory Muscular Training

REGIONAL LUNG VENTILATION DISTRIBUTION AMONG INDIVIDUALS WITH CHRONIC HEART FAILURE AFTER AN INSPIRATORY MUSCLE TRAINING PROGRAMM: A RANDOMIZED CONTROLLED CLINICAL TRIAL

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Inspiratory muscle training; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Departamento de Fisioterapia-Universidade Federal de pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory Muscle Training	Other: Inspiratory muscle training; 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.
Placebo Comparator: Control group; Patients from the control group were also assessed weekly to ensure homogenization of the learning effect for the manometer maneuver.	Other: Control group; Patients from the control group were also assessed weekly to ensure homogenization of the learning effect for the manometer maneuver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months
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).	3 mounths
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.	3 months

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 4, 2012
• First Posted (Estimate): May 7, 2012

Study Record Updates

• Last Update Posted (Estimate): June 13, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Heart failure; respiratory muscles; optoelectronic plethysmography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: tese02