The effect of physical activity with mediation tracker on body composition and self-esteem in sedentary adult
Design
This research is a field trial based on the purpose of the clinical trial and in terms of collecting information. 45 participants were randomly assigned into three groups of 15 (two intervention and one control group).
Settings and conduct
The selected participants fill up the self-esteem questionnaire and the exercise motivation logbook before the start of physical activity tests. Also, all participants were asked to complete the Self-Esteem Questionnaire at the first week, six weeks and the twelfth week. Afterwards, all participants will take a one-mile racquet test and a body composition test plus fat percentage in the first week, the sixth week and the twelfth week. The total time of the test protocol and a one-mile racquet test is 35 minutes, which includes warm-up and exercise protocols, tests and cool down, which take place between 10 and 12 noon.
Participants/Inclusion and exclusion criteria
Participants in the study include elderly people aged more than 60 years old and in the city of Tehran at the home for the aged of district 8, they are served 24 hours a day.
Intervention groups
The intervention group number one consists of 15 people who use the activity tracker and do physical activity, and the intervention group number 2 consists of 15 people who only do physical activity and do not use the activity tracker, and the control group includes 15 People who do not use activity trackers, not physical activity.
Main outcome variables
Body composition, Self-esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180423039396N1
Registration date:2019-01-03, 1397/10/13
Registration timing:retrospective
Last update:2019-01-03, 1397/10/13
Update count:0
Registration date
2019-01-03, 1397/10/13
Registrant information
Name
Mohsen Tavakoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7728 4827
Email address
tavakoli@riau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2018-10-23, 1397/08/01
Trial completion date
2018-10-23, 1397/08/01
Scientific title
The effect of physical activity with mediation tracker on body composition and self-esteem in sedentary adult
Public title
The effect of physical activity with mediation tracker in the Elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 60 years of age
Having physical health, Mental and lack of illness
Low mobility of elderly
Non-drug addiction
Exclusion criteria:
Having mental illnesses such as high depression
Having physical illnesses such as disability and high blood pressure
Dislike of physical activity
Dislike of participate in research
Age
From 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
45 participants participated randomly in three groups of 15 (two experimental and one control group); The test group number one consists of 15 people who use the activity tracker and do physical activity; And the test group number two consists of 15 people who only do physical activity and do not use the activity tracker; And the control group includes 15 people who do not use the activity tracker and do physical activity, and follow daily life according to normal nursing home programs. To match the triple groups, the pre-test results of the EMI-2 logbook were used and list all participants in the order list from the highest to the least incentive to participate in the sport, and then the first three randomly assigned to the group The trilogy is located in the same way, the next three to the end of the list will be matched randomly into triple groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University - Science and Research Branch
Street address
Islamic Azad University of Science and Research Branch - Shahdia Hesarak Blvd - University Square - End of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.IAU.SRB.REC.1397.013
Health conditions studied
1
Description of health condition studied
Sedentary adult
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physical activity
Timepoint
Twelve weeks and three sessions each week
Method of measurement
Walk test is a mile rackport
2
Description
Activity Tracker
Timepoint
Twelve weeks and three sessions each week
Method of measurement
The Xiaomi smart detector has a global version of the heart rate sensor, accelerometer and altimeter that records activity and sleep information. The Xiaomi wrist can measure time, speed, calorie intake, average speed, increase and decrease in height and heart rate during exercise.
3
Description
Body composition
Timepoint
The first week and the sixth week and the twelfth week
Method of measurement
The body composition measurement test will measure humanometric data such as height and weight for calculating body mass index (BMI) as well as the waist circumference of the hip circumference to calculate the waist to hip ratio (WHR) using tape measurements and standard scales. The body fat percentage test is also measured by measuring the fat under the skin by caliper in the dorsum of the trunk muscle and leg muscle, which is used by the modified Lumann formula (Slater).
4
Description
Self-esteem
Timepoint
The first week and the sixth week and the twelfth week
Method of measurement
Eysenck Self-Esteem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group number one consists of 15 people who use the activity tracker and do physical activity. The total time of the test protocol and a one-mile racquet test is 35 minutes, which includes warm-up and exercise protocols, tests and cool down, which take place between 10 and 12 noon. The warm-up phase includes walking, exercise and stretching for 10 minutes to prepare participants for the main training program. The main training phase, which includes a walking test of a mile of racquet, which is about 20 minutes. Cooling stage consisting of tensile and tensile movements for 5 minutes to overcome fatigue and accelerate the process of recovery and disposal of lactic acid and waste products from blood and muscle.
Category
Other
2
Description
The intervention group number two consists of 15 people who only do physical activity and do not use an activity tracker. The total time of the test protocol and a one-mile racquet test is 35 minutes, which includes warm-up and exercise protocols, tests and cool down, which take place between 10 and 12 noon. The warm-up phase includes walking, exercise and stretching for 10 minutes to prepare participants for the main training program. The main training phase, which includes a walking test of a mile of racquet, which is about 20 minutes. Cooling stage consisting of tensile and tensile movements for 5 minutes to overcome fatigue and accelerate the process of recovery and disposal of lactic acid and waste products from blood and muscle.
Category
Other
3
Description
The control group consists of 15 people who do not use activity trackers or physical activity.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Home for the Aged
Full name of responsible person
Mohsen Tavakoli
Street address
District 8 of Tehran - Home for the Aged
City
Tehran
Province
Tehran
Postal code
1635663896
Phone
+98 21 7728 4827
Email
mt_1355@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Azizabadi Farahani
Street address
Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4484 5147
Email
mt_1355@yahoo.com
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
100
Public or private sector
Private
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
Mohsen Tavakoli
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4484 5147
Email
mt_1355@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Tavakoli
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4484 5147
Email
mt_1355@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Tavakoli
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4484 5147
Email
mt_1355@yahoo.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
The data and results of the research are available after the conclusion
When the data will become available and for how long
Start accessing information one year after printing results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Specialists and academic researchers
From where data/document is obtainable
Author
What processes are involved for a request to access data/document