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Effects of the Breathing Muscular Training of Institutionalized Elderly

This study has been completed.
Sponsor:
Information provided by:
Universidade Castelo Branco
ClinicalTrials.gov Identifier:
NCT01001156
First received: October 21, 2009
Last updated: October 22, 2009
Last verified: October 2009
History of Changes
  Purpose

The purpose of this study was to use associated breathing exercises the incentive inspiratory of load lineal pressoric, Threshold® IMT, or of load pressoric alinear, Voldyne®, in institutionalized elderly, comparing the effect of the same ones in the training of the breathing musculature, for the increment of the muscular strength, expressed by the maximum breathing pressures (MIP and MEP).

From the total number of admitted people (n = 52), 12 individuals were excluded: one by appearance of cognitive deficit, one by death (stroke), one by visual deficit (glaucoma) and twelve by failure to continue the training. After selecting the sample, the 37 participants were randomly divided into three different groups: the Threshold Group (TG; n = 13, age = 70. 93 ± 8.41 years old, BMI = 24.06 ± 3.69 kg/m²), the Voldyne Group (VG; n = 12, age = 70.54 ± 7. 73 years-old, BMI = 27.17 ± 5.66 kg/m²) and the Control Group (CG; n= 12, age = 73. 92 ± 7.28 years-old, BMI = 24.80 ± 5.42 kg/m²). The TG and VG received treatment with respiratory exercises and Threshold and Voldyne muscular training, respectively. The CG received only respiratory exercises.


Condition Intervention Phase
In Brazil, Which Has an Increasing Number of Elderly People.
The Physiological Alterations of Aging Are Systemic.
 Other: Comparison of different breathing muscular training
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of the Breathing Muscular Training to Volume and the Pressure in MIP and MEP of Institutionalized Elderly

Further study details as provided by Universidade Castelo Branco:

Primary Outcome Measures:
  • Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O [ Time Frame: One minute ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Before and after the respiratory muscle training, inspiratory and expiratory strength were evaluated and analysed through the maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), respectively. [ Time Frame: Ten weeks ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Comparison of different breathing muscular training
    Three times per week for ten weeks, thirty minutes.
    Other Name: Aged, Breathing Muscles, Strength Muscles.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The elderly individuals were required to be in good physical and cognitive condition to be considered for the study

Exclusion Criteria:

  • Eliminated participation by those who had acute-phase infections of the cardio-respiratory system and those who did not have a satisfactory cognitive level to understand the evaluation tests and the exercises performed in the treatment programs.
  • Also excluded were people who presented skeletal muscle and neurological sequel, presented metabolic syndromes or failed to adhere to the training program for more than one week.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001156

Locations
Brazil
Marilia de Andrade Fonseca
Rio de Janeiro, Brazil, 22780-160
Sponsors and Collaborators
Universidade Castelo Branco
Investigators
Principal Investigator: Marilia A. Fonseca, Esp. Universidaade Castelo Branco
Study Director: Samaria A. Cader, Dr. Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- Brazil
Study Chair: Silvia C. Bacelar, Dr. National Institute of Cancer (INCA) - Rio de Janeiro - RJ - Brazil
Study Chair: Elirez B. Silva, Dr. Gama Filho University (UGF) - Rio de Janeiro - RJ - Brazil
Study Chair: Silvânia O. Leal, Esp. Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- Brazil
Study Director: Estelio M. Dantas, Phd. Laboratory of Human Kinetics Bioscience from Castelo Branco University LABIMH-UCB/ Rio de Janeiro- RJ- Brazil
  More Information

Additional Information:
Comparative study of elderly inpatients clinically diagnosed with community-acquired pneumonia, with or without radiological confirmation.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Marilia de Andrade Fonseca, Castelo Branco University
ClinicalTrials.gov Identifier: NCT01001156     History of Changes
Other Study ID Numbers: 0043-2008
Study First Received: October 21, 2009
Last Updated: October 22, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Castelo Branco:
Aged
Breathing Muscles
Strength Muscles
Institution of long Permanence for elderly

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013