The purpose of the present study was to investigate the effect of endurance training on serum clara cell and surfactant D proteins in male smokers
Design
Experience and control group; community based and pragmatic; parallel group; not blinded; randomised
Settings and conduct
1 month aerobic Exercise (3 times at week) with intensity 70%-75% of maximum oxygen consumption and for 30 minute at Bagshomal Trail in Tabriz and without blindness of groups
Participants/Inclusion and exclusion criteria
Untrained; Healthy and No Illness; Smoker
Intervention groups
Intervention group: ten healthy male smokers without regular exercise. control group: ten healthy male smokers without regular exercise
Main outcome variables
Surfactant and Clara cell
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039637N2
Registration date:2018-07-16, 1397/04/25
Registration timing:retrospective
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Hadi Pourmanaf
Name of organization / entity
Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 41 3656 1262
Email address
hadi.pvrmnaf@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-06-27, 1396/04/06
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-06-27, 1396/04/06
Trial completion date
empty
Scientific title
The effect of endurance training on serum clara cell and surfactant D proteins in male smokers
Public title
Effect of endurance activity on respiratory
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
No participation in any regular exercise program in the six months prior to the start of the research
Healthy and No Illness
Exclusion criteria:
Non-smoker
Regular exercise
Age
From 23 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university
Street address
No. Enghlab Blvd
City
Tehran
Province
Tehran
Postal code
14398-13117
Approval date
2016-06-23, 1395/04/03
Ethics committee reference number
IR.ut.Rec.1395015
Health conditions studied
1
Description of health condition studied
Relation between endurance training on serum clara cell and surfactant D proteins in male smokers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clara cell
Timepoint
Before the first endurance exercise and 60 minute after the last endurance exercise
Method of measurement
Clara cell kite
2
Description
Surfactant D protein
Timepoint
Before the first endurance exercise and 60 minute after the last endurance exercise
Method of measurement
Surfactant D protein kite
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 healthy and untrained smoker men that for 1 month (12 session) and 3 time in per week and each session performed 30 minutes aerobic exercise with intensity of 70%_75% maximum oxygen consumption. They received training at a training session before training began. They also did not take any interventionist medication.
Category
Other
2
Description
Control group: 10 healthy and untrained smokers who did not have any intensive and regular exercise for one month. And they did not take any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz
Full name of responsible person
Hadi Pourmanaf
Street address
No. Shafa Ave, Azadi Blvd, Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5155874743
Phone
+98 41 3656 1262
Email
hadipourmanaf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University
Full name of responsible person
Siroos Choobineh
Street address
No. Amir Abad shomali Blvd, Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۸-۱۳۱۱۷
Phone
+98 41 3656 1263
Email
Choobineh@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Hadi Pourmanaf
Position
Teacher training
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
NO. 30, Vahdat Ave., Abasi Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
5156717611
Phone
+98 41 3656 1262
Email
hadipourmanaf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Siroos Choobineh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. Englab Alvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 41 3656 1263
Email
Sirooscc@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Hadi Pourmanaf
Position
Teacher training
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
NO. 30 Vahdat Ave., Abasi Blvd., Tabriz Town
City
tabriz
Province
East Azarbaijan
Postal code
5156717611
Phone
+98 41 3656 1262
Email
hadipourmanaf@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Adress: Sportdezh.rzb.ir
When the data will become available and for how long
Every time
To whom data/document is available
Everyone
Under which criteria data/document could be used
Patern
From where data/document is obtainable
Sportdezh.rzb.ir
What processes are involved for a request to access data/document