Comparing the effect of intensity and type of endurance exercise on airway epithelial integrity in healthy adult men
Design
A randomized, sealed-envelope, unblinded, community-based trial with 3 intervention groups and no control group on 30 samples.
Settings and conduct
20 minutes of endurance exercise (continuous endurance exercise with an intensity of 80 to 90% of maximum heart rate, continuous endurance exercise with an intensity of 65 to 75% of maximum heart rate, and intermittent endurance exercise with an intensity of 80 to 90% of maximum heart rate) on a treadmill in the Exercise Physiology Laboratory of the University of Tabriz, from 9 am to 12 pm and without blinding the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a history of at least 1 exercise session per week; Exclusion criteria: having heart and lung diseases and smokers
Intervention groups
Intervention group: 30 healthy active men (3 groups of 10) who perform at least one and a maximum of 3 exercise sessions per week.
Main outcome variables
Serum levels of Clara cell protein, surfactant protein D, and the ratio of Clara cell protein to surfactant protein D in healthy, active men
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039637N5
Registration date:2025-05-22, 1404/03/01
Registration timing:retrospective
Last update:2025-05-22, 1404/03/01
Update count:0
Registration date
2025-05-22, 1404/03/01
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
2025-05-19, 1404/02/29
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of intensity and type of endurance exercise on airway epithelial integrity in healthy adult men
Public title
The effect of aerobic endurance exercise on airway epithelial integrity in healthy adult men
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adult men between the ages of 18 and 30
Those who participate at least 1 and a maximum of 3 exercise sessions per week
Exclusion criteria:
prior history of specific diseases such as pulmonary and cardiovascular diseases
prior history of tobacco smoking for at least six months prior to intervention
prior history of using β2-agonists and any anti-inflammatory medications or supplements
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Using stratified randomization, individuals were placed in two homogeneous groups (High-intensity endurance exercise group, moderate-intensity endurance exercise group, and interval endurance exercise group). Then random cluster randomization for each group was used. The randomization tool also sealed the envelope. The randomization unit was also individual. Individual numbers inside the pack identified the subjects of each group. And did not allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of University of Tabriz
Street address
University of Tabriz, Central Library and Documentation Center of Tabriz University, First Floor, Secretariat of the University's Biomedical Ethics Committee
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2025-04-27, 1404/02/07
Ethics committee reference number
IR.TABRIZU.REC.1404.013
Health conditions studied
1
Description of health condition studied
Does not apply
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum levels of Clara cell protein in healthy, active men
Timepoint
Blood sampling before endurance exercise, 60 minutes and one day after endurance exercise
Method of measurement
Clara cell protein kit
2
Description
Serum levels of Surfactant D protein in healthy, active men
Timepoint
Blood sampling before endurance exercise, 60 minutes and one day after endurance exercise
Method of measurement
Surfactant D protein kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 healthy active men who will perform 20 minutes of continuous endurance exercise at an intensity of 85-90 percent of maximum heart rate
Category
Other
2
Description
Intervention group: 10 healthy active men who will perform 20 minutes of interval endurance exercise at an intensity of 85-90 percent of maximum heart rate.
Category
Other
3
Description
Control group: 10 healthy active men who will perform 20 minutes of continuous endurance exercise at an intensity of 65-70% of maximum heart rate