Protocol summary

Summary
Valsalva maneuver is naturally done during behaviors such as coughing, heavy lifting, urinary excretion, and defecation. Despite the fact that both the body position and the valsalva maneuver may affect the cardiovascular autonomic system activity, so far, few studies were conducted about the effect of body position on heart rate responses to the valsalva maneuver. The aim of this study is to assess heart rate response to the valsalva maneuver in the standing, sitting, lying, and squatting postures in healthy young males. The design of this study determines that each subject (of the total subjects n=19) has to position in each of the four postures with a ten minute interval. Meanwhile standard valsalva maneuver, ECG lead II continuously is recorded for five min. Then, time and frequency domains of heart rate variability criteria are calculated. The inclusion criteria are being male and age of 19 to 24 and the exclusion criteria are chronic diseases (such as diabetes, hypertension, epilepsy, etc.), smokers, and chronic medication consumers. The interventions of the study include sitting, standing, and squatting positions in comparison with supine position. The mean and standard deviation of sequential R-R intervals are the primary outcomes of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040111236N7
Registration date: 2016-11-15, 1395/08/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Esmaeil Akbari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 12 1223 0855
Email address
akbari_esmaeil@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-01-10, 1395/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of body posture (standing, sitting, supine and squatting) on heart rate to valsalva maneuver in male healthy subjects.
Public title
The effect of body posture on heart rate response to valsalva maneuver.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: male; age between 19-24 years old. Exclusion criteria: chronic disease (i.e. diabetes mellitus, hypertension, epilepsy and etc); smoker; under regular medication.
Age
From 19 years old to 24 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Postal code
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
92482

Health conditions studied

1

Description of health condition studied
Healthy subjects
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mean of RR interval
Timepoint
Five minutes during of supine or other position
Method of measurement
Time domain analysis of ECG

2

Description
Standard deviation of RR interval
Timepoint
Five minutes during of supine or other position
Method of measurement
Time domain analysis of ECG

Secondary outcomes

1

Description
High frequency power spectrum
Timepoint
Five minutes during of supine or other position
Method of measurement
Frequency domain analysis of ECG

2

Description
Low frequency power spectrum
Timepoint
Five minutes during of supine or other position
Method of measurement
Frequency domain analysis of ECG

Intervention groups

1

Description
Supine position
Category
Behavior

2

Description
Sitting position
Category
Behavior

3

Description
Squatting position
Category
Behavior

4

Description
Standing position
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Medicine, Mazandaran University of Medical Sciences
Full name of responsible person
Esmaeil Akbari
Street address
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad-ali Enayati
Street address
Deputy for Research, Moalem Square, Buil. No 2, Mazandaran University of Medical Sciences, Sari, Iran.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran Sari
City
Sari
Postal code
Phone
+98 11 4422 1919
Fax
Email
Akbari_esmaeil@mazums.ac.ir; Akbari_esmaeil@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
City
Sari
Postal code
Phone
+98 11 4422 1919
Fax
Email
Akbari_esmaeil@mazums.ac.ir; Akbari_esmaeil@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
City
Sari
Postal code
Phone
+98 11 4422 1919
Fax
Email
Akbari_esmaeil@mazums.ac.ir; Akbari_esmaeil@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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