Inspiratory Muscular Training

NCT01593007 | Completed DMC

• 1 other identifier: tese02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; respiratory muscles; optoelectronic plethysmography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of respiratory mechanics by Optoelectronic Plethysmography

  3 months

• Evaluation of submaximal functional capacity

  3 mounths

• Quality of Life Questionnaire: Minnesota Living With Heart Failure Questionnaire (MLHFQ)

  3 months

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

Inspiratory Muscle Training

Other: Inspiratory muscle training

Control group

PLACEBO COMPARATOR

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

Other: Control group

Interventions

Inspiratory muscle training OTHER

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.

Inspiratory Muscle Training

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator

Study Sites (1)

Departamento de Fisioterapia-Universidade Federal de pernambuco

Recife, Pernambuco, Brazil

Location

Related Publications (2)

• 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.

  PMID: 18436118 RESULT

• 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.

  PMID: 17395049 RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 13, 2012

Record last verified: 2011-10

Locations

BR (1)