The aim of the study is the evaluation of the effect of carbohydrate mouth rinsing on functional capacity including time to exhaustion and rating of perceived exertion during exercise in overweight women.
Design
Two arms parallel group randomised trial with blinded participants and outcome assessor
Settings and conduct
The study is conducting in Emam Khomeini Hospital. All of the subjects participate in two sessions of Bruce test: the first test will be done on all of the participants without mouth rinsing (baseline test). The second test will be done with mouth rinsing with a carbohydrate solution (intervention group) or simple water (control group). Assessor and participants will be blind to the content of the solutions.
Participants/Inclusion and exclusion criteria
Female sex;
Without pregnancy or regular physical activity or cigarette smoking;
Without any diseases that affect the heart rate, diet or physical activity;
Without significant weight reduction over the past 6 months.
Intervention groups
The study has two groups:
1) Carbohydrate solution mouth rinsing
2) Simple water mouth rinsing.
both of groups have an exercise test with Bruce protocol on the treadmill till maximal exhaustion.
Main outcome variables
Functional capacity;
Time to exhaustion;
Rating of perceived exertion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111025007903N10
Registration date:2019-02-13, 1397/11/24
Registration timing:registered_while_recruiting
Last update:2019-02-13, 1397/11/24
Update count:0
Registration date
2019-02-13, 1397/11/24
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of carbohydrate mouth rinsing on functional capacity in overweight women
Public title
Carbohydrate mouth rinsing and functional capacity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female sex
Without pregnancy or regular physical activity or cigarette smoking
Without any diseases that affect the heart rate, diet or physical activity
Without significant weight reduction over the past 6 months
Exclusion criteria:
Refuse participation in the trial
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
We use simple randomization by a table of random numbers. Allocation concealment is done by the bottles that the content of them is not visible. The assessor and the participants will be blind to the content of the bottles.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, investigator and data analyser are blind. A co-worker who does not participate in the other trial sections delivers the carbohydrate solution or simple water to the participants according to a randomization table.
Placebo
Used
Assignment
Parallel
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,Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.267
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Functional capacity
Timepoint
Baseline and 72 hours later
Method of measurement
Running time on treadmill and Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the group will rinse the 6% carbohydrate solution every 5 minutes till to exhaustion on the treadmill. The time to exhaustion will be compared with baseline.
Category
Prevention
2
Description
Control group: the group will rinse the simple water solution every 5 minutes till to exhaustion on the treadmill. The time to exhaustion will be compared with baseline.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Faezeh Maleklou
Street address
Emam Khomeini hospital complex., Dr. Gharib St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2282
Email
z_alizadeh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arefeh Ahmadi
Street address
4th Floor, The Center of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3612
Email
z_alizadeh@tums.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 of Medical Sciences
Proportion provided by this source
100
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 of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No7, Opposite of Shariati Hospital, Ale-Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
57814395
Phone
+98 21 8863 0227
Email
z_alizadeh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports medicine research center, Opposite of Shariati Hospital, Ale-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
14395578
Phone
+98 21886302278
Fax
Email
z_alizadeh@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
Zahra Alizadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Street address
No7, Ale-Ahmad Highway, Opposite of Shariati Hospital, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
14395-578
Phone
+98 21 6119 2282
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
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
Primary outcomes and others according to researchers request
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Please contact with this e-mail: z_alizadeh@tums.ac.ir
Under which criteria data/document could be used
Please contact with this e-mail: z_alizadeh@tums.ac.ir
From where data/document is obtainable
Please contact with this e-mail: z_alizadeh@tums.ac.ir
What processes are involved for a request to access data/document
Please contact with this e-mail: z_alizadeh@tums.ac.ir