Protocol summary

Summary
The aim of the present study is to compare the impact of a single bout of high intensity interval versus moderate intensity continuous exercise on post-exercise oxygen consumption and resting metabolic rate in over weight sedentary women. The study population are 15 women who come to the sports medicine clinic to receive an exercise program for weight reduction and have the inclusion criteria. Subjects will participate in two modes of exercise sessions on treadmill, 1 week apart. At the end of each exercise session, study variables will be measured. One exercise session is continuous moderate intensity exercise (50% of heart rate reserve (HRR) or 55% of the maximal oxygen consumption (VO2max)) and the other session is interval high intensity exercise with the exercise to rest ratio of 2 to 1 (4 min high intensity with 80% of HRR or 82% of the VO2max and 2 min low intensity with 40% of HRR or 45% of the VO2max). Continuous moderate intensity exercise will be prescribed for 30 minutes and the duration of high intensity interval exercise will be adjusted on the basis of the measurement of oxygen consumption to have two isocaloric exercise sessions. Measurement of the study variables including oxygen consumption, respiratory exchange ratio, resting metabolic rate, carbohydrate and fat percentage at resting metabolic rate will be done by a gas analysis metabolic cart before, during and after each exercise session. The main outcome is oxygen consumption after each exercise session with the aim of detecting the changes of resting metabolic rate after exercise and secondary outcomes are respiratory exchange ratio, resting metabolic rate, CHO and fat percentage at resting metabolic rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020124401N3
Registration date: 2017-05-26, 1396/03/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-26, 1396/03/05
Registrant information
Name
Reza Mazaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 6782
Email address
mazaheri_md@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2017-04-01, 1396/01/12
Expected recruitment end date
2017-10-01, 1396/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of a single bout of high intensity interval training versus moderate continuous exercise on excess post-exercise oxygen consumption in over-weight sedentary women
Public title
The impact of two modes of exercise on energy expenditure of over-weight sedentary women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Healthy over-weight women with BMI of 25-29.9 kg.m-2; Age between 20 to 45 years old; Sedentary life style (According to American college of sports medicine (ACSM), activity less than 30 minutes moderate intensity exercise, 3 times per week); No history of smoking; No history of weight gain or weight loss (more than 10 percent change) during the previous 6 month; Not pregnant; No history of taking any medications or supplements; Not having organized exercise activity during the last three months; Low risk based on ACSM criteria. Exclusion criteria: Any history of heart or pulmonary disease; Suffering any injuries during exercise which inhibit from continuing activity; Not planning to participate in the study; Endocrine problems including thyroid gland.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-12-12, 1395/09/22
Ethics committee reference number
IR.TUMS.REC.1394.220

Health conditions studied

1

Description of health condition studied
Over-weight sedentary women
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Oxygen consumption after each exercise session
Timepoint
During the first ten minutes and then 1.5 and 2 hours within the recovery period after the exercise session
Method of measurement
Gas analysis metabolic cart

Secondary outcomes

1

Description
Resting metabolic rate
Timepoint
1.5 and 2 hours within the recovery period after exercise session
Method of measurement
Gas analysis metabolic cart

2

Description
Respiratory exchange ratio
Timepoint
1.5 and 2 hours within the recovery period after exercise session
Method of measurement
Gas analysis metabolic cart

3

Description
Carbohydrate and fat percentage at resting metabolic rate
Timepoint
1.5 and 2 hours within the recovery period after exercise session
Method of measurement
Gas analysis metabolic cart

Intervention groups

1

Description
Continuous moderate intensity exercise (50% HRR or 55% VO2max) which will be prescribed for 30 minutes.
Category
Lifestyle

2

Description
One week later, high intensity interval exercise with the exercise to rest ratio of 2 to 1 (4 min high intensity with 80% of HRR or 82% of the VO2max and 2 min low intensity with 40% of HRR or 45% of the VO2max). Continuous moderate intensity exercise will be prescribed for 30 minutes and the duration of high intensity interval exercise will be adjusted on the basis of the measurement of oxygen consumption to have two isocaloric exercise sessions.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine Center, Imam Khomeini Hospital
Full name of responsible person
Reza Mazaheri
Street address
Imam Khomeini hospital, End of Keshavarz Blv
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Mazaheri
Street address
Sports Medicine Center, Imam Khomeini Hospital, End of Keshavarz Blv
City
Tehran
Grant name
---
Grant code / Reference number
---
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran 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
Sports Medicine Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Mazaheri
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, End of Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
mazaheri_md@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sports Medicine Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Mazaheri
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, End of Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
mazaheri_md@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Mazaheri
Position
Associate Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
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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