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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-5dmpkr |
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Date of registration:
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10/05/2012 |
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Primary sponsor: |
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Public title:
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Effect of physical therapy in the diaphragm of the elderly on the function of the lungs
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Scientific title:
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Study of the transcutaneous electrical diaphragmatic muscle stimulation. |
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Date of first enrolment:
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01/04/2011 |
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Target sample size:
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21 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-5dmpkr/ |
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Study type:
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Study design:
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Parallel, two arms, single blinded trial, not randomized controlled clinical trial
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Eli Maria
Forti |
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Address:
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Rodovia do Açúcar, km 156
13.400-911
Piracicaba
Brazil |
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Telephone:
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(19) 3124-1515 |
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Email:
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empforti@unimep.br |
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Affiliation:
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Universidade Metodista de Piracicaba |
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Name:
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Eli Maria
Forti |
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Address:
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Rodovia do Açúcar, km 156
13.400-911
Piracicaba
Brazil |
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Telephone:
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(19) 3124-1515 |
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Email:
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empforti@unimep.br |
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Affiliation:
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Universidade Metodista de Piracicaba |
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Key inclusion & exclusion criteria
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Inclusion criteria: Male volunteers;
Aged between 67 and 79 years;
Not practicing physical exercises regularly.
Exclusion criteria: Elderly Smokers;
History of pulmonary disease, neuromuscular disorders and postural muscles that affect the respiratory or cardiovascular diseases.
Age minimum:
67Y
Age maximum:
79Y
Gender:
M
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Health Condition(s) or Problem(s) studied
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Aging, Sarcopenia C10.597.613.612.500 G07.700.320.124
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Intervention(s)
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Experimental Group (n = 14): Elderly men who received transcutaneous electrical diaphragmatic stimulation to the motor threshold intensity.
Parameters of stimulation: depolarized current; frequency of 30 Hz; respiratory rate of 14 rpm; rise time (ramp) of 0.7 s; pulse width of 1.2 ms stimulation motor threshold; electrodes silicon carbon placed two in the parasternal region, next to the xiphoid process in the sense of muscle fibers, and the other two electrodes were fixed on the motor points of the diaphragm muscle, between the 6th and 7th intercostal space in axillary lines right anterior and left, parallel to the muscle fibers.
Placebo group (n = 07): The volunteers received the same treatment, but as the sensory threshold intensity.
In both groups, respiratory muscle training was performed once a day for 30 minutes, five days per week for two weeks
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Primary Outcome(s)
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Increased diaphragmatic muscle strength, assessed by the manometer. The manometer is an analog device with operating range of 0 to ± 300 cmH2O, to check the measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Expected to find measures considered technically satisfactory maximal inspiration, lasting at least 2 seconds without air leak and values close to each other (> 10%), computing the largest absolute value obtained.
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Secondary Outcome(s)
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Improvement in lung volume and capacity, as assessed by respirometry, where volunteers remain seated, holding the silicone mask involving the nasal and oral cavities, preventing the escape of air. Expected to find increased tidal volume, minute volume and vital capacity.
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Source(s) of Monetary Support
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Universidade Metodista de Piracicaba - Piracicaba, SP, Brazil
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