Inspiratory Muscular Training

NCT ID: NCT01593007

Last Updated: 2012-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inspiratory Muscle Training

Inspiratory Muscle Training

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: 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.

Control group

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

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control group

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Ciência e Tecnologia de Pernambuco

OTHER

Sponsor Role: collaborator

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Daniella Cunha Brandao

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Departamento de Fisioterapia-Universidade Federal de pernambuco

Recife, Pernambuco, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 18436118 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17395049 (View on PubMed)

Other Identifiers

tese02

Identifier Type: -

Identifier Source: org_study_id