investigate the impact of treadmill and cycle ergometer exercise tests on ventilatory outcomes in healthy adolescents
Design
Subjects attend to lab in three sessions. In first session, resting oxygen consumption, height, weight and anthropometric characteristics were measure, thereafter; they were made familiar with protocols and instruments. In the second and third sessions, for measuring VO2max, the subjects perform treadmill and ergometer protocols in a counterbalance manner so that the first half perform ergometer then cycle protocol and the second half perform vice versa. Two protocols were separated by 4-6 days. All tests were administrated at 10-12 am in 21±1ºC. To determine VO2max, ramp protocol was used.
Settings and conduct
All tests will be held at Shahid Beheshti University.
Maximal treadmill exercise test will be perform on a motor driven, electronically controlled treadmill Techno Gym Med (Italy). The main treadmill protocol implemented with a slope of 1 percent. The initial speed was 30% of the final speed computed in the pilot study, and to increase the exercise workload by each minute, we use the final speed minus the initial speed, divided by 10.
Maximal exercise test performe on a motor driven, electronically controlled cycle ergometer Monark-839 (Sweden). The protocol of this test start with an initial strength of 30% of the maximum resistance where VO2 max could be achieve (Based on the results of pilot study). Pedaling between 40 and 60 rounds per minute.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: , age 11-16 years old, healthy Exclusion Criteria: Use medication or supplements or any illness
Intervention groups
The test of VO2 using a treadmill and cycle to evaluate respiratory efficiency in two types of exercise.
Main outcome variables
Time ؛ Heart rate ؛ Ventilatory efficiency index ؛ Minute Ventilation؛ End-tidal carbon dioxide pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220129053867N1
Registration date:2022-03-02, 1400/12/11
Registration timing:prospective
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Rostam Alizadeh
Name of organization / entity
Ilam university
Country
Iran (Islamic Republic of)
Phone
+98 84 5924 1463
Email address
r.alizadeh@ilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects Type of Exercise on Ventilatory Efficiency in 11-16 Years Healthy Individuals: A Randomized Clinical Trial
Public title
The Effects of Treadmill and Cycle Ergometer on Ventilatory Efficiency in 11-16 Years Healthy Individuals: A Randomized Clinical Trial
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
age 11-16 years old,
healthy (with no major pulmonary, cardiovascular, or metabolic diseases, such as diabetes)
Exclusion criteria:
Adolescents who took any medication or dietary supplement was excluded from this study.
Age
From 11 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
52
More than 1 sample in each individual
Number of samples in each individual:
2
cycle ergometer and treadmill- counterbalance
Randomization (investigator's opinion)
Randomized
Randomization description
In the second and third sessions, for measuring VO2max, the subjects performe treadmill and ergometer protocols in a counterbalance manner so that the first half performed ergometer then cycle protocol and the second half performed vice versa. Two protocols were separate by 5-7 days.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects randomly select the type of exercise, the clinical caregiver, the outcome evaluator, and the data analyzer are actually blind.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam university of medical sciences
Street address
Ilam University of Medical Sciences, Pajoohesh Blvd, Ilam
City
ILAM
Province
Ilam
Postal code
6939177143
Approval date
2019-04-29, 1398/02/09
Ethics committee reference number
IR.MEDILAM.REC.1398.010
Health conditions studied
1
Description of health condition studied
ventilatory efficiency (VE ⁄ VCO2)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained VE/VCO2 breath by breath during the test
Timepoint
All data were reported at two time points: 1) Anaerobic Threshold V-Slop Method (AT), 2) PEAK.
Method of measurement
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained breath by breath during the test.
2
Description
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained VE breath by breath during the test
Timepoint
All data were reported at two time points: 1) Anaerobic Threshold V-Slop Method (AT), 2) PEAK.
Method of measurement
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained breath by breath during the test.
3
Description
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained PetCO2 breath by breath during the test
Timepoint
All data were reported at two time points: 1) Anaerobic Threshold V-Slop Method (AT), 2) PEAK.
Method of measurement
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained breath by breath during the test.
4
Description
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained VD/VT breath by breath during the test
Timepoint
All data were reported at two time points: 1) Anaerobic Threshold V-Slop Method (AT), 2) PEAK.
Method of measurement
Gas exchange measures (MetaLyzer3B-R2- Cortex Germany) were obtained breath by breath during the test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Maximal treadmill exercise test will be perform on a motor driven, electronically controlled treadmill Techno Gym Med (Italy). The main treadmill protocol implemented with a slope of 1 percent. The initial speed was 30% of the final speed computed in the pilot study, and to increase the exercise workload by each minute, we use the final speed minus the initial speed, divided by 10.
Category
Diagnosis
2
Description
Intervention group 2: Maximal exercise test performe on a motor driven, electronically controlled cycle ergometer Monark-839 (Sweden). The protocol of this test start with an initial strength of 30% of the maximum resistance where VO2 max could be achieve (Based on the results of pilot study). Pedaling between 40 and 60 rounds per minute.