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Investigating the effect of 7-minute high intensity exercise on health-related indicators, body composition and blood sugar and fat profiles in women with overweight, obesity and lack of physical activity during the COVID-19 pandemic.

Protocol summary

Study aim
Investigating the effect of 7-minute intense exercise on health-related indicators, body composition and sugar and fat profile in women with overweight and obesity and lack of physical activity.
Design
clinical trial, randomized with control group, single blinded, with parallel groups design of 45 participants which rand function of Excel software was used for randomization
Settings and conduct
The place of research: Isfahan University. After the pre-test in the 7-minute training group, training will be carried out for two days under the supervision of a sports expert at the University of Isfahan and four days at home with telephone supervision at the end of every week. The walking training group also takes a 30-minute walk with moderate intensity at Isfahan University
Participants/Inclusion and exclusion criteria
The inclusion criteria : overweight and obese women aged 25 to 65 Exclusion criteria : participation in regular physical activity, history of cardiorespiratory diseases, pregnancy , smoking, weight loss diet.
Intervention groups
7-minute training group: training protocol: including butterfly, sitting on the wall, swimming, sit-ups, stairs, squats, back of the arm, front plank, kneeling, plank with turning to the sides , front lunge and side plank. 30 seconds of activity, 10 seconds of rest Walking group: 30-minute walking training protocol with moderate intensity (60-70% of maximum heart rate). The control group does their daily routine
Main outcome variables
skin fold; waist to hip ratio; blood pressure;hand grip; FBS; triglyceride; cholesterol; HDL; LDL

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210213050340N1
Registration date: 2022-09-12, 1401/06/21
Registration timing: registered_while_recruiting

Last update: 2022-09-12, 1401/06/21
Update count: 0
Registration date
2022-09-12, 1401/06/21
Registrant information
Name
Nakisa Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3781 0981
Email address
nakisasoltani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-09, 1401/06/18
Expected recruitment end date
2022-09-19, 1401/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of 7-minute high intensity exercise on health-related indicators, body composition and blood sugar and fat profiles in women with overweight, obesity and lack of physical activity during the COVID-19 pandemic.
Public title
The effect of 7-minute high intensity exercise on health-related indicators
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
healthy women overweight or obese no regular physical activity in past 6 months no medication no use of alcohol no chronic diseases Not having a special diet in the last six months
Exclusion criteria:
the age lower than 25 and higher than 60 years old body mass index lower than 25
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 53
Randomization (investigator's opinion)
Randomized
Randomization description
Study's enrolled participants undergo permuted block randomization with the block sizes varying 3 to 12. Random sequences are generated using “blockrand” package in R software version 3.6.2.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome evaluator and statistician will be blinded to the intervention and control groups. Blinding is done by assigning codes to groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of medical university of Isfahan
Street address
No.63, Rashidaldin Ave, khaghani street, Hakimnezamistreet,
City
Isfahan
Province
Isfehan
Postal code
8175858989
Approval date
2022-05-16, 1401/02/26
Ethics committee reference number
IR.ARI.MUI.REC.1401.038

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
subcutaneous fat percentage
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
Measure using a caliper

2

Description
Maximum oxygen consumption(vo2max)
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
treadmill

3

Description
hand grip
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
hand grip dynamometr

4

Description
blood pressure
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
Sphygmomanometer

5

Description
fasting blood suger
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
blood sample

6

Description
waist to hip ratio
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
tape measure

Secondary outcomes

1

Description
cholestrol
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
blood sample

2

Description
triglyceride
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
blood sample

3

Description
LDL
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
blood sample

4

Description
HDL
Timepoint
at the beginning of the study and eight weeks later
Method of measurement
blood sample

Intervention groups

1

Description
7-minute training group: The 7-minute training protocol of an intense circuit training includes 12 simple exercises, which include butterfly, wall sitting, swimming, sit-ups, stairs, squats, triceps, front plank, knee up, plank With turning to the sides, front lunge and side plank. Each station is 30 seconds long and subjects have 10 seconds to prepare for the next move. This exercise will be carried out for two days under the supervision of a sports specialist at work and four days at home with telephone supervision at the end of each week. The period of intervention is 8 weeks.
Category
Lifestyle

2

Description
walking group will walk for 30 minutes with moderate intensity (60-70% of the maximum heart rate) in the open environment. The period of intervention is 8 weeks.
Category
Lifestyle

3

Description
Control group: the group that receives no intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan university
Full name of responsible person
Dr. Nafiseh Esmaeil
Street address
Hazarjarib Street, Isfahan University of medical science , Faculty of Medicine, Department of Immunology
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3793 4207
Fax
Email
n_esmaeil@med.ui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nafiseh Esmaeil
Street address
Hazarjarib Street, Isfahan University of medical science , Faculty of Medicine, Department of Immunology
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3793 4207
Email
n_esmaiel@med.mui.ac.ir
Grant name
Grant code / Reference number
54416
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Nafiseh Esmail
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Hezar jerib Ave. , Isfahan University of Medical Sciences School of Medicine,Department of Immunology
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3793 4207
Email
n_esmaeil @ med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Nafiseh Esmaiel
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Hezar jerib Ave. , Isfahan University of Medical Sciences School of Medicine,Department of Immunology
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3793 4207
Email
n_esmaeil @ med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Volga Hovsepian
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Hezar jerib Ave, university of Isfahan, faculty of sport science , laboratory of sport science
City
Isfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3793 4207
Email
hovsepian.v@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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