Ignite Creation Date:
2024-05-05 @ 9:58 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01001156
Status:
COMPLETED
Last Update Posted:
2009-10-23
First Post:
2009-10-21
Brief Title:
Effects of the Breathing Muscular Training of Institutionalized Elderly
Sponsor:
Universidade Camilo Castelo Branco
Organization:
Universidade Camilo Castelo Branco
Study Overview
Official Title:
Effects of the Breathing Muscular Training to Volume and the Pressure in MIP and MEP of Institutionalized Elderly
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 93 841 years old BMI 2406 369 kgm² the Voldyne Group VG n 12 age 7054 7 73 years-old BMI 2717 566 kgm² and the Control Group CG n 12 age 73 92 728 years-old BMI 2480 542 kgm² The TG and VG received treatment with respiratory exercises and Threshold and Voldyne muscular training respectively The CG received only respiratory exercises
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 93 841 years old BMI 2406 369 kgm² the Voldyne Group VG n 12 age 7054 7 73 years-old BMI 2717 566 kgm² and the Control Group CG n 12 age 73 92 728 years-old BMI 2480 542 kgm² 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 MedUSA-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 ie 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 activeresistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint activeresistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk activeresistance exercise of lateral rotation of the trunk activeresistance 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 patients 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 activeresistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint activeresistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk activeresistance exercise of lateral rotation of the trunk activeresistance 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 TreatmentThe 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 Students 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 005 Excel and the SPSS v140 statistical package program were used to evaluate the data
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 MedUSA-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 ie 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 activeresistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint activeresistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk activeresistance exercise of lateral rotation of the trunk activeresistance 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 patients 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 activeresistance exercise of horizontal adduction-abduction and flexion-extension of the shoulder joint activeresistance exercise of anterior flexion associated with rotation of the trunk and lateral flexion of the trunk activeresistance exercise of lateral rotation of the trunk activeresistance 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 TreatmentThe 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 Students 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 005 Excel and the SPSS v140 statistical package program were used to evaluate the data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None