Protocol summary

Study aim
Overall Objective: To compare the effect of 8 weeks of Pilates and aerobic exercise with weight loss diet on respiratory and anthropometric indices in obese women.
Design
The clinical trial consisted of a control group with parallel aerobics and Pilates groups, a single-blind, non-randomized study on 48 overweight and obese individuals.
Settings and conduct
This study was randomly selected from Al-Zahra Municipal Clubs (District 5). In District 5, two clubs, 42 and 50, were randomly selected to do the job. The required specifications for this project were announced and the people volunteered and after checking the conditions, they entered the project.
Participants/Inclusion and exclusion criteria
Healthy overweight and obese people in their 30s and 50s
Intervention groups
Pilates group: 8 weeks (three times a week) Pilates exercises with weight loss diet Aerobics group: 8 weeks (three times a week) Aerobic exercise with weight loss diet Control group: 8 weeks weight loss diet
Main outcome variables
Weight Loss; Reduce body fat percentage, increase forced vital capacity; Increased Forced Expiratory Volume in the first second

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200718048127N1
Registration date: 2020-07-18, 1399/04/28
Registration timing: retrospective

Last update: 2020-07-18, 1399/04/28
Update count: 0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Maryam Sadat Kasaii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4431 4865
Email address
maryam.kasaii@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-05, 1398/04/14
Expected recruitment end date
2019-08-20, 1398/05/29
Actual recruitment start date
2019-07-04, 1398/04/13
Actual recruitment end date
2019-08-22, 1398/05/31
Trial completion date
2019-12-30, 1398/10/09
Scientific title
The effect of Pilates vs. Aerobic training and low calorie diet on respiratory parameters and anthropometric indexes in overweight/obese women
Public title
Comparison of the combined effect of physical activity and diet on respiration and body composition
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People do not have any metabolic diseases Do not have a specific illness or respiratory problem They can attend the class for 2 months People with a body mass index above 25
Exclusion criteria:
Smoking
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 48
Actual sample size reached: 33
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All three groups of participants thought that they had been subjected to an intervention that was in fact a regime intervention for them, but that some people were physically active and some were not.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Organization in Biomedical Research, Science and Research Branch of Islamic Azad University
Street address
No. 8, South Niloufar Alley, Shahran St., Tehran
City
Tehran
Province
Tehran
Postal code
1474963761
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.IAU.SRB.REC.1398.097

Health conditions studied

1

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

Primary outcomes

1

Description
weight
Timepoint
Beginning of study and 2 months later (end of study)
Method of measurement
Body Composition

2

Description
Percentage of body fat
Timepoint
Beginning of study and 2 months later (end of study)
Method of measurement
Body Composition

3

Description
Lean body mass
Timepoint
Beginning of study and 2 months later (end of study)
Method of measurement
Body Composition

4

Description
Forced Vital Capacity
Timepoint
Beginning of study and 2 months later (end of study)
Method of measurement
Spirometry

5

Description
Forced Expiratory Volume in first second
Timepoint
Beginning of study and 2 months later (end of study)
Method of measurement
spirometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Aerobics. Eight weeks (three times a week) aerobic exercise with an intensity of 60 to 75% of the maximum heart rate along with a specific monthly weight loss diet for each person. The exercises included 5 minutes of warm-up and 50 minutes of main body training and 5 minutes of cooling.
Category
Treatment - Other

2

Description
Intervention group 2: Pilates. Eight weeks (three times a week) Pilates exercise with an intensity of 60 to 75% of the maximum heart rate along with a specific monthly weight loss diet for each person. The exercises included 5 minutes of warm-up and 50 minutes of main body training and 5 minutes of cooling.
Category
Treatment - Other

3

Description
Control group: Two months specific weight loss diet for each person. Do not participate in any sports classes
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Sports Complex 50
Full name of responsible person
Fateme Fazel
Street address
Tehran, Shahran St. East Fifth Alley
City
Tehran
Province
Tehran
Postal code
1474963761
Phone
+98 21 4433 7450
Email
mkasaii1@gmail.com
Web page address
http://koodak24.ir/directories/details/7886/%D9%85%D8%AC%D9%85%D9%88%D8%B9%D9%87-%D9%88%D8%B1%D8%B2%D8%B4%DB%8C-%D8%A7%D9%84%D8%B2%D9%87%D8%B1%D8%A7(%D8%B3)-%D9%85%D8%B9%D8%B1%D9%81%D8%AA-50

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Bazgir
Street address
End of Sattari Highway, Simon Bolivar, University Square, Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
bazgir@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Maryam Sadat Kasaii
Position
M.A student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 8, Niloufar South Alley, Shahran St., Tehran
City
Tehran
Province
Tehran
Postal code
1474963761
Phone
+98 21 4431 4865
Email
mkasaii1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Sadat Kasaii
Position
M.S student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 8,Niloufar jonoubi Alley, Shahran St,Teahtan
City
Tehran
Province
Tehran
Postal code
1474963761
Phone
+98 21 4431 4865
Fax
Email
maryam.kasaii@srbiau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Sadat Kasaii
Position
M.S student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No 8,Niloufar jonoubi Alley, Shahran St,Teahtan
City
Tehran
Province
Tehran
Postal code
1474963761
Phone
+98 21 4431 4865
Fax
Email
maryam.kasaii@srbiau.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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