Effects of the Breathing Muscular Training of Institutionalized Elderly
Primary Purpose
In Brazil, Which Has an Increasing Number of Elderly People., The Physiological Alterations of Aging Are Systemic.
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Comparison of different breathing muscular training
Sponsored by
About this trial
This is an interventional prevention trial for In Brazil, Which Has an Increasing Number of Elderly People. focused on measuring Aged, Breathing Muscles, Strength Muscles, Institution of long Permanence for elderly
Eligibility 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.
Sites / Locations
- Marilia de Andrade Fonseca
Outcomes
Primary Outcome Measures
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O
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.
Full Information
NCT ID
NCT01001156
First Posted
October 21, 2009
Last Updated
October 22, 2009
Sponsor
Universidade Camilo Castelo Branco
1. Study Identification
Unique Protocol Identification Number
NCT01001156
Brief Title
Effects of the Breathing Muscular Training of Institutionalized Elderly
Official Title
Effects of the Breathing Muscular Training to Volume and the Pressure in MIP and MEP of Institutionalized Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Camilo Castelo Branco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The physiologic alterations of the aging are systemic and they seem to be more evident in the institutionalized elderly. The advanced age is associated to the decrease of the force of the skeletal muscles, as well as the one of the muscles respiratory. In the breathing system happen important muscle-skeletal alterations, interfering in the mechanics ventilatory. The changes in the compliance of the thoracic wall and of the lung stcruture resulting in imprisonment of air, air-trapping ", increasing the breathing work simultaneously the and functional residual capacity (FRC) with consequent decrease of the pressure maximum expiratory. Also the decreases of the pick of flow expiratory and changes in the curve flow-volume contributing to the closing of the outlying aerial roads. This way the breathing muscular function will be strongly harmed and correlated with the state nutritional and it forces muscular outlying. Besides, modifications in the curvature of the diaphragm, with a negative effect for the capacity to generate muscular force, collaborating for the decrease inspiratory.
The participant was completely evaluated, including personal information, medical history and a physical examination.
Measurement of Translation provided gratis.
MIP and MEP: 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. This was measured using a device called a vacuum manometer (analogical with operational intervals of -120 to + 120 cmH2O, Critical Med/USA-2002 and display with scale intervals of 4 cmH2O). During MIP measurements, a nasal clip was used, which prevented air from escaping during the evaluation. In MIP measurements, the mouth and oropharynx can create negative pressure that can alter the results depending on whether the glottis opens (correct form) or closes (improper form). To prevent this interference of the orofacial musculature in the MIP measurements, an escape orifice was placed in the measurement instrument. This orifice relieved the pressure without significantly affecting the pressure produced by the respiratory muscles. Five tests were carried out to get three acceptable measures (i.e., duration of at least 2 seconds and an absence of emptying).
Acceptable tests were required to have at least two reproducible measurements (a maximum difference of 5% between the two maxima). A rest of at least one minute between tests was used for better equalization of the volumes and (consequently) the attainment of maximum pressures. To measure MEP, the patient was instructed to inhale until reaching total pulmonary capacity (TPC) and to carry through a supported expiratory effort down to the residual volume (RV). A seated position was used when measuring both MIP and MEP.
Threshold Group Training: after the measurement of the initial MIP and MEP (pre-training), the elderly individuals of the TG were submitted to a respiratory exercise program. The research of Ide et al. (2007) showed that this program contributes to an increase in chest expansion in healthy elderly people. The program was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements. After training, the Threshold® IMT (Respironics USA - 2004) was used. This device is commercially offered in the form of a transparent plastic cylinder; at one end is a valve that is kept closed for the positive pressure by a spring, while at the other end is a nipple. The valve blocks the aerial flow until the patient generates inspiratory pressure sufficient to overcome the spring.
The utilization of Threshold in this research began with a gradual load, starting with 50% of the MIP of each individual and increasing 10% per week until the fourth week. From the fifth week on, this was increased by 5% until 100% was reached in the eighth week or the maximum pressure value of the Threshold IMT (41 cmH2O) was reached. Thereafter, this value was kept constant in the final two weeks. The sessions lasted 20 minutes and consisted of seven series of strengthening (2 minutes each) with an interval of 1 minute between the series; sessions were conducted three times per week for ten weeks.
In the use of this training program, all the elderly individuals had been evaluated separately and trained in a group with individualized attention.
Voldyne Group Training: The same respiratory exercises used in the TG were used in the VG.
The maximum inspiratory sustentation technique (MIS) using the Voldyne mobilizes great pulmonary volumes and thereby increases the intra-alveolar pressure until the end of the supported inspiration. The increase in the intra-alveolar pressure is directly proportional to the contractile strength of the respiratory muscles (diaphragm and accessories), thus justifying the fact that intense muscular activity is required to reach the total pulmonary capacity (TPC) and to support inspiration at this level.
The use of EI (Voldyne®) incentive spirometry as muscular training in elderly people and as a basis for physiotherapy followed some guidelines. The patient's trunk was positioned at 30º relative to the horizontal plane, providing more diaphragmatic conscription. The device was positioned vertically. The volume indicator was visible to the patient to provide visual biofeedback. The patient was instructed to carry out a slow and deep inspiration until reaching TPC from the functional residual capacity (FRC). Slow inspiration favours a laminar flow. A sustentation of the maximum inspiration of around three seconds was recommended. Expiration occurred normally until the FRC was reached. During the use of Voldyne, patient hyperventilation was avoided. Intervals of 60 seconds between the inspiration support maxima were recommended 11. The elderly subjects received a verbal command to initiate a new inspiration. In this study, the Voldyne was used for 20 minutes, that is, 40 repetitions with 2 repetitions per minute. The procedure lasted 10 weeks at a frequency of three times per week. The group was supervised intermittently during the twenty minutes to ensure that hyperventilation was not occurring.
Control Group Training: This group received only respiratory exercises. The exercises was composed of the following exercises: active/resistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint; active/resistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk; active/resistance exercise of lateral rotation of the trunk; active/resistance exercise to put the superior members above the head. The relaxation protocol consisted of inspiration and deep expiration without the accompaniment of other movements.
Statistical Treatment:The average and standard deviation (av ± sd) were calculated for age, body mass index, maximum respiratory pressure and functional autonomy. The normality of the sample was evaluated by the Shapiro-Wilk test and the homogeneity of the variance by the test of Levene. For the within-groups analysis variables, the parametric Student's t test or Wilcoxon was used when appropriate (for homogeneous or heterogeneous distribution of the data, respectively). For the between-groups evaluation, the nonparametric Kruskal-Wallis test was used followed by the Mann-Whitney multiple comparisons test. The statistical significance level adopted was p < 0.05. Excel and the SPSS v14.0 statistical package program were used to evaluate the data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In Brazil, Which Has an Increasing Number of Elderly People., The Physiological Alterations of Aging Are Systemic.
Keywords
Aged, Breathing Muscles, Strength Muscles, Institution of long Permanence for elderly
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Comparison of different breathing muscular training
Other Intervention Name(s)
Aged, Breathing Muscles, Strength Muscles.
Intervention Description
Three times per week for ten weeks, thirty minutes.
Primary Outcome Measure Information:
Title
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) in cmH2O
Time Frame
One minute
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilia A. Fonseca, Esp.
Organizational Affiliation
Universidaade Castelo Branco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samaria A. Cader, Dr.
Organizational Affiliation
Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- Brazil
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Silvia C. Bacelar, Dr.
Organizational Affiliation
National Institute of Cancer (INCA) - Rio de Janeiro - RJ - Brazil
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elirez B. Silva, Dr.
Organizational Affiliation
Gama Filho University (UGF) - Rio de Janeiro - RJ - Brazil
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Silvânia O. Leal, Esp.
Organizational Affiliation
Laboratory of Human Kinetics Bioscience from Castelo Branco University - LABIMH-UCB/Rio de Janeiro - RJ- Brazil
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Estelio M. Dantas, Phd.
Organizational Affiliation
Laboratory of Human Kinetics Bioscience from Castelo Branco University LABIMH-UCB/ Rio de Janeiro- RJ- Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Marilia de Andrade Fonseca
City
Rio de Janeiro
ZIP/Postal Code
22780-160
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
16772388
Citation
Hill K, Jenkins SC, Philippe DL, Cecins N, Shepherd KL, Green DJ, Hillman DR, Eastwood PR. High-intensity inspiratory muscle training in COPD. Eur Respir J. 2006 Jun;27(6):1119-28. doi: 10.1183/09031936.06.00105205.
Results Reference
result
Links:
URL
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1806-37132007000300007&lng=pt.doi:10.1590/S1806-37132007000300007
Description
Comparative study of elderly inpatients clinically diagnosed with community-acquired pneumonia, with or without radiological confirmation.
Learn more about this trial
Effects of the Breathing Muscular Training of Institutionalized Elderly
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