Comparison of the effect of calorie restriction and exercise training with or without foot reflexology on body composition and cardiovascular diseases risk factors in obese females
Investigating the effect of two methods of exercise and food restriction with foot reflexology massage on body composition and risk factors of cardiovascular diseases in obese women
Design
This study was a clinical trial with a double-arm, single-blind parallel design that will last for 14 weeks. This study will be conducted in Sadra Sports Club in Tabriz, Iran. 40 participants will be randomly divided into one of two groups: EX+CR+ foot reflexology: n=20 and EX+CR: n=20: using block and table of random numbers in Excel software. The sample size was calculated using G*Power software (version 3.0.10) considering the possible loss of 40 people (20 people for the group). Allocation for each group was created using blocking and a table of random numbers. Block sizes were not declared to avoid selection bias.
Settings and conduct
This study will be conducted in Sadra Sports Club in Tabriz, Iran. Daily energy consumption will be calculated . Then, the caloric intake limit while performing resistance + aerobic exercises for 14 weeks for intervention group 2 and the calorie intake limit while performing resistance + aerobic + massage recovery exercises for intervention group 1 will be obtained by deducting 500 kcal from daily energy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20-50 years old, healthy soles and no foot abnormalities, no history of receiving reflexology massage, no history of chronic pain such as arthritis.
Exclusion criteria: unwillingness of patients to participate or continue the study and not attending more than one session in the intervention process
Intervention groups
Intervention group 1: caloric restriction + sports exercises + foot reflexology
Intervention group 2: calorie restriction intervention + sports exercises
Main outcome variables
body composition
Risk factors for cardiovascular diseases
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240517061818N1
Registration date:2024-05-25, 1403/03/05
Registration timing:registered_while_recruiting
Last update:2024-05-25, 1403/03/05
Update count:0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Leyla Esmealy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 992 393 6560
Email address
leylaesmealy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of calorie restriction and exercise training with or without foot reflexology on body composition and cardiovascular diseases risk factors in obese females
Public title
The effect of calorie restriction and exercise training with or without foot reflexology on body composition and cardiovascular diseases risk factors
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
age 20-50 years
desire to participate in research
with normal foot soles and without foot abnormalities (calluses, scars, neuropathy)
no mental health issues (depression or anxiety) or taking neuropsychiatric drugs
no perception disorders
no history of foot reflexology
no history of chronic pain such as arthritis
without history of medical problems
without having a special diet (diabetic, low-salt and low-fat, etc.)
no taking special medicine or supplement.
Exclusion criteria:
Pregnancy
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Assignments to each group were generated using blocking and a table of random numbers. The size of blocks was not declared to prevent selection bias. In addition, blockings were available only to a person who was not informed of the study process. The randomization was written on sequentially numbered, opaque, sealed envelope papers, and participants were selected into one of the two study groups (EX+CR+ foot reflexology or EX+CR). Participants and the person responsible for data collection were blinded to the random allocation process. The sampling process continued until a sufficient number of patients were recruited.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the statistical analyst and outcome assessor will be blinded to the type of intervention of the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tabriz university
Street address
29 bahman blovd
City
Tabriz
Province
East Azarbaijan
Postal code
5155673964
Approval date
2024-05-04, 1403/02/15
Ethics committee reference number
IR.TABRIZU.REC.1403.013
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
body composition
Timepoint
Body composition will be evaluated before (T0), at the end of the seventh (T7) and fourteenth (T14) weeks of the intervention.
Method of measurement
Assessment of body composition (body fat, BF, %, lean mass - KG FFM, %, muscle mass MM) with an electric bioimpedance (BIA) device (Tanita Body Composition Analyzer BC-418), Olympia model 3/3, Jawon Co., South Korea will be measured.
2
Description
cardiovascular diseases risk factors
Timepoint
Cardiovascular risk factor will be evaluated before (T0), at the end of the seventh (T7) and fourteenth (T14) weeks of the intervention.
Method of measurement
The levels of the following blood metabolic variables were examined in all study participants: glucose (GL), total cholesterol (TCh), HDL, LDL and triglyceride (TG). Smoking, drinking or vigorous exercise were prohibited. The blood sample was taken from 8 to 9 am in the fasting state, and 5 ml each time from the brachial vein of the person in a sitting position. Then it was poured inside the test tube containing a saturated solution of ethylene diamine tetra acetic acid (EDTA) made by Pars Azmoun. To separate the plasma, the blood was centrifuged for 15 minutes at a speed of 3500 rpm by a Hettich centrifuge from Germany. The plasma was frozen at a temperature of minus 80 degrees Celsius in a Mihan Azma freezer made in Iran. Enzymatic method will be used to measure the plasma levels of glucose, TG, cholesterol, LDL and HDL using the kits of Pars Azmoun company using the automatic biochemistry analyzer (Flexor / Selectra EL 200) made by Lab-Plus International, Germany.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This intervention group will receive caloric restriction + resistance and aerobic exercise + foot reflexology. At first, a three-day food diary will be taken from the participants, and then their daily calorie intake will be calculated according to the formula of total daily energy. 500 kilocalories will be deducted from this amount and then the calories received for the whole period will be calculated. At the same time, the patients' sports exercises will be performed in a way that will help their energy consumption up to 700 kilocalories. For this group, foot reflexology intervention will be performed according to the principles provided by a herbalist.
Category
Prevention
2
Description
Intervention group 2: This intervention group will receive caloric restriction + resistance and aerobic exercise. At first, a three-day food diary will be taken from the participants, and then their daily calorie intake will be calculated according to the formula of total daily energy. 500 kilocalories will be deducted from this amount and then the calories received for the whole period will be calculated. At the same time, the patients' sports exercises will be performed in a way that will help their energy consumption up to 700 kilocalories.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadra sport center
Full name of responsible person
Leyla Esmealy
Street address
29 Bahman blovd
City
Tabriz
Province
East Azarbaijan
Postal code
5155673964
Phone
+98 992 393 6560
Email
leylaesmealy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university
Full name of responsible person
Shirin Yazdani
Street address
29 Bahman blovd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3637 8742
Email
sh_yazdani@tabrizu.ac.ir
Grant name
Shirin Yazdani
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university
Proportion provided by this source
30
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
university of Tabriz
Full name of responsible person
Leyla Esmealy
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
29 Bahman blovd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3637 8742
Email
leylaesmealy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
university of Tabriz
Full name of responsible person
Leyla Esmealy
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
29 Bahman blovd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3637 8742
Email
leylaesmealy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
university of Tabriz
Full name of responsible person
Leyla Esmealy
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
29 Bahman blovd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3637 8742
Email
leylaesmealy@gmail.com
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
In this study, the information of the participants will be confidential, only the average age and body mass index will be reported as demographic variables. Information related to body composition and risk factors of cardiovascular diseases, which are the main variables of the study, will be measured and controlled and reported in the three previous, seventh and fourteenth weeks of the intervention.
When the data will become available and for how long
The publication time of the documents and data files of this study will be published approximately three months after the end of the intervention and data analysis, approximately in December 1403.
To whom data/document is available
All researchers can send a request to receive data or other documentation of the present study by observing the principle of referencing. The data of this study will be available to researchers working in academic and scientific institutions, and also people who are engaged in industry can apply to receive them.
Under which criteria data/document could be used
All researchers, following the principle of referencing, can send requests to the researchers via email to conduct similar studies in the field of obesity control and prevention regarding receiving data or other documentation of the present study. The data of this study will be available to researchers working in academic and scientific institutions, and also people who are engaged in industry can apply to receive them.
From where data/document is obtainable
Leyla Esmealy
099293936560
leylaesmealy@gmail.com
What processes are involved for a request to access data/document
The request for access to the study data will be made by email to leylaesmealy@gmail.com within one to two days.