The effect of aerobic exercise and caffeine consumption on quality of life and life expectancy of overweight men in Gachsaran
Design
The study population of all overweight men aged 40-60 years in Gachsaran voluntarily participated in the study and randomly divided into 4 research groups.
Settings and conduct
Initially, by announcing a call and announcement at Gachsaran Sports Clubs, Offices and Public Places, all overweight men aged 40 to 60 are invited to participate in the study. The subjects were then randomly divided into four groups of 15, (1) control, (2) caffeine, (3) aerobic exercise, and (4) aerobic exercise + caffeine supplement. Questionnaire of quality of life and life expectancy will be completed by the subjects in pre-test and post-test. Aerobic exercise is also performed for eight weeks three sessions per week and each session for about 25 to 40 minutes with an intensity of 60 to 80 percent of maximum heart rate. Caffeine supplementation groups also consume two capsules daily containing 200 mg of caffeine manufactured by the Al-Hawa Iranian Company, licensed by the Ministry of Health.
Participants/Inclusion and exclusion criteria
Subjects aged 40 to 60 years.BMI>30
Exclusion criteria:Special diseases like hypertension; Smoking; Regular exercises in two last years
Intervention groups
The control group(1) did not exercise for 2 months and did not take silymarin.The aerobic training group (2) trained for eight weeks, three sessions per week and each session for 20-40 minutes with an intensity of 60 to 85% of the stored heart rate.The caffeine group (3) consumes two 200 mg silicone-coated Capsule daily.Aerobic Exercise +caffeine (4) group exercise for 2 months and use caffeine capsule.
Main outcome variables
Quality of life؛ Life expectancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046506N2
Registration date:2020-03-10, 1398/12/20
Registration timing:retrospective
Last update:2020-03-10, 1398/12/20
Update count:0
Registration date
2020-03-10, 1398/12/20
Registrant information
Name
Ali Khajehlandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3233 5910
Email address
a.khajehlandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic training and caffeine consumption on quality of life and life expectancy in overweight men in Gachsaran
Public title
The effect of aerobic training and caffeine consumption on quality of life and life expectancy in overweight men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The lack regular exercise in the last two years
The age of the subjects is 40 to 60 years
Exclusion criteria:
A history of heart disease
Smoking in the last six months
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to four groups, Excel software is used as follows:
First, a list of participants is compiled and we assign each participant a specific number using the RAW function, then randomly select each participant using the RANDBETWEEN and VLOOKUP functions and assign them to each participant. We assign 4 groups to groups. The first, second, third and fourth subjects were assigned to the control group, aerobic exercise group, caffeine consumption group, and aerobic training + caffeine consumption group, respectively. Others are assigned to groups in the same way.
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
Ethics committee of Islamic Azad University ,Gachsaran Branch
Street address
Daneshjo Blvd.,Gachsaran
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
63876-75818
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.IAU.IAUG.REC.1398.007
Health conditions studied
1
Description of health condition studied
Overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Quality of life
Timepoint
Two months after intervention
Method of measurement
World Health Organization Quality of Life Questionnaire
Secondary outcomes
1
Description
Life expectancy
Timepoint
Two months after training
Method of measurement
Schneider Life Expectancy Questionnaire
Intervention groups
1
Description
Intervention group: Three sessions per week and each session lasting about 25 to 40 minutes, the subjects exercising at 65 to 80 percent of their maximum heart rate for 40 minutes for 8 weeks.
Category
Other
2
Description
Intervention group: Eight weeks, daily consumption of two 200 mg capsules containing caffeine manufactured by Alhavi Iran
Category
Other
3
Description
Intervention group: Three sessions per week and each session for about 25 to 40 minutes, subjects with 65-80% of maximal heart rate, 40 minutes plus eight weeks, two daily 200 mg capsules containing caffeine manufactured by Alhavi Iran
Category
Other
4
Description
Control group: Consume capsules containing wheat flour
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Gachcaran Branch
Full name of responsible person
ALI Khajehlandi
Street address
No.12, North Tenth Ave., Valiasr Blvd., Gachsaran
City
Gachcaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797786
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Islamic Azad University Gachsaran Branch
Full name of responsible person
Amin Mohammadi
Street address
No.31,Western Eighth Ave., shahed Blvd.,Razmandegan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581796481
Phone
+98 74 3233 5333
Email
Amin.mohammadi8@gmail.com
Grant name
معاونت پژوهشی ، دانشگاه آزاد اسلامی واحد گچساران
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Islamic Azad University Gachsaran Branch
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 Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sport Sciences
Street address
No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
No.12, North Tenth Ave., Valiasr Blvd.,Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sport Sciences
Street address
Physical Education and Sport Sciences
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@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