Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000786099
Ethics application status
Approved
Date submitted
19/09/2010
Date registered
22/09/2010
Date last updated
22/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Transcutaneous Electrical Diaphragmatic Stimulation influences the Heart Rate Variability decreasing sympathetic activity and increasing parasympathetic activity in healthy subjects: a controlled clinical trial
Scientific title
Evaluation Of The Effects Of Transcutaneous Electrical Diaphragmatic Stimulation On Cardiac Autonomic Balance In Healthy Individuals
Secondary ID [1] 252618 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evaluation of the Effects of Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) on cardiac autonomic balance in healthy individuals. 258110 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258290 258290 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The subjects were instrumented with cardiofrequencimeter (Polar RS800CX). For implementation of transcutaneous electric diaphragmatic stimulation (TEDS), silicon electrodes were positioned in height from sixth to eighth intercostal spaces, using the apparatus Neurodyn Transcutaneous electrical nerve stimulation/ Functional electrical stimulation (TENS / FES) - 02 output channels – Ibramed. The parameters used for TEDS were: current frequency of 30 Hz, pulse duration of 25 microseconds, Ton= 2, Toff = 3, with the minimum intensity to promote a palpable contraction of the diaphragm. Recordings were taken 07 minutes before, 12 minutes during and 05 minutes after the TEDS.
Intervention code [1] 257132 0
Treatment: Devices
Comparator / control treatment
The subjects were their own controls. Recordings of heart rate variability were taken before, during and after TEDS.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259139 0
there was a significant reduction in the low frequency (LF) band of heart rate variability
Timepoint [1] 259139 0
during the transcutaneous electric diaphragmatic stimulation (TEDS)
Primary outcome [2] 259140 0
there was a significant increase in the high frequency (HF) band of heart rate variability
Timepoint [2] 259140 0
during the transcutaneous electric diaphragmatic stimulation (TEDS)
Primary outcome [3] 259141 0
According to LF / HF ratio, there was predominance of HF band showing a reduction on it value
Timepoint [3] 259141 0
during the transcutaneous electric diaphragmatic stimulation (TEDS)
Secondary outcome [1] 265463 0
The autonomic predominance of the LF band on the heart returned.
Timepoint [1] 265463 0
soon after transcutaneous electric diaphragmatic stimulation (TEDS)

Eligibility
Key inclusion criteria
Volunteers without prior known cardiac pathology, who did physical exercise sporadically (no more than once a week).
Minimum age
20 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who were using drugs that interfere with the autonomic activity of the heart as well as smokers and drinkers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment outside Australia
Country [1] 2850 0
Brazil
State/province [1] 2850 0

Funding & Sponsors
Funding source category [1] 257581 0
Self funded/Unfunded
Name [1] 257581 0
Country [1] 257581 0
Brazil
Primary sponsor type
Individual
Name
Luana Godinho Maynard
Address
Rua Itabaiana 591, Ed. Ana Maria apt 702
49015110
Aracaju-SE
Country
Brazil
Secondary sponsor category [1] 256808 0
None
Name [1] 256808 0
Address [1] 256808 0
Country [1] 256808 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31596 0
Address 31596 0
Country 31596 0
Phone 31596 0
Fax 31596 0
Email 31596 0
Contact person for public queries
Name 14843 0
Manoel Luiz Cerqueira Neto
Address 14843 0
Fundacao de Beneficencia Hospital de Cirurgia
Av. Desembargador Maynard, 174
Cirurgia
49055-210
Aracaju- SE
Country 14843 0
Brazil
Phone 14843 0
+55 79 21067312 or +55 79 98215475
Fax 14843 0
Email 14843 0
[email protected]
Contact person for scientific queries
Name 5771 0
Luana Godinho Maynard
Address 5771 0
Rua Itabaiana, 591 Ed. Ana Maria, apt 702
Sao Jose
49015110
Aracaju-SE
Country 5771 0
Brazil
Phone 5771 0
+55 79 88547698
Fax 5771 0
Email 5771 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.