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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-5dmpkr
Date of registration: 10/05/2012
Primary sponsor: Universidade Metodista de Piracicaba - Piracicaba, SP, Brazil
Public title: Effect of physical therapy in the diaphragm of the elderly on the function of the lungs
Scientific title: Study of the transcutaneous electrical diaphragmatic muscle stimulation.
Date of first enrolment: 01/04/2011
Target sample size: 21
Recruitment status: recruitment completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-5dmpkr/
Study type: 
Study design:  Parallel, two arms, single blinded trial, not randomized controlled clinical trial
 
Countries of recruitment
Brazil
Contacts
Name: Eli Maria  Forti
Address:  Rodovia do Açúcar, km 156 13.400-911 Piracicaba Brazil
Telephone: (19) 3124-1515
Email: empforti@unimep.br
Affiliation:  Universidade Metodista de Piracicaba
Name: Eli Maria  Forti
Address:  Rodovia do Açúcar, km 156 13.400-911 Piracicaba Brazil
Telephone: (19) 3124-1515
Email: empforti@unimep.br
Affiliation:  Universidade Metodista de Piracicaba
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Aging, Sarcopenia
C10.597.613.612.500
G07.700.320.124
Intervention(s)
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
Primary Outcome(s)
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.
Secondary Outcome(s)
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.
Secondary ID(s)
08/05
Source(s) of Monetary Support
Universidade Metodista de Piracicaba - Piracicaba, SP, Brazil
Secondary Sponsor(s)
Universidade Metodista de Piracicaba - Piracicaba, SP, Brazil
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