Protocol summary

Study aim
Investigating the effect of eight weeks of spinning exercises on lipid profile and some metabolic indicators and physical fitness of overweight women
Design
Clinical trial with control groups, exercise+placebo, exercise+caffeine and caffeine, with factorial groups, available and targeted sampling but random replacement of people in the groups, with blinding of statistical analyzer, phase 3 on 40 overweight women
Settings and conduct
This study will be done in the sports hall of Shahrood city, spinning exercise will be done on a spinning bike for 2 months, three days a week. Caffeine or placebo will be given to subjects 60 minutes before the start of exercise. The data analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: body mass index (BMI) above 25 and below 35 kg/m2 Exclusion criteria: people with a history of cardiovascular disease, respiratory disease, diabetes, pregnancy and breastfeeding, use of anti-inflammatory drugs and special drugs, abnormal blood pressure
Intervention groups
1- The group that had both spinning exercise (indoor cycling) and caffeine supplement use. 2- The group that had both spinning exercise and placebo. 3- The group that only consumed caffeine. 4- Control group (without exercise and taking supplements or placebo)
Main outcome variables
lipid profile (cholesterol, triglyceride, LDL and HDL); Body composition: body fat percentage, waist circumference, hip circumference, abdominal circumference, waist-to-hip ratio and weight (BMI); maximum upper body and lower body strength; upper body and lower body muscular endurance; aerobic power; anaerobic power; balance نماد «مورد تأیید انجمن»

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220906055902N1
Registration date: 2023-11-01, 1402/08/10
Registration timing: registered_while_recruiting

Last update: 2023-11-01, 1402/08/10
Update count: 0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
Somayeh Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 4216
Email address
s.rajabi@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-14, 1402/07/22
Expected recruitment end date
2023-12-13, 1402/09/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of spinning training and caffeine supplementation on lipid profile, body composition and functional fitness of overweight women
Public title
The effect of exercise and caffeine on health and performance indicators
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a body mass index between 25 and 35 kg/m2
Exclusion criteria:
History of cardiovascular respiratory disease, diabetes, pregnancy and breastfeeding Taking anti-inflammatory drugs and special drugs
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study analyst will not be informed of the nature of the groups and we will identify each group with a number.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrood Islamic Azad University
Street address
University Boulevard, Khatam Al Anbia Hospital, Faculty of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
3614871151
Approval date
2023-01-30, 1401/11/10
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1401.072

Health conditions studied

1

Description of health condition studied
Overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified - Simple obesity NOS

Primary outcomes

1

Description
Lipid profile (cholesterol, triglyceride, LDL and HDL)
Timepoint
Before and after the intervention
Method of measurement
Blood sampling using a diagnostic kit for cholesterol, triglycerides, LDL and HDL

Secondary outcomes

1

Description
Weight
Timepoint
Before and after the intervention
Method of measurement
scales

2

Description
Body Mass Index
Timepoint
Before and after the intervention
Method of measurement
The ratio of weight to the square of height

3

Description
waist circumference
Timepoint
Before and after the intervention
Method of measurement
Meter

4

Description
Abdominal circumference
Timepoint
Before and after the intervention
Method of measurement
Meter

5

Description
hip circumference
Timepoint
Before and after the intervention
Method of measurement
Meter

6

Description
Waist to hip ratio
Timepoint
Before and after the intervention
Method of measurement
Meter

7

Description
fat percentage
Timepoint
Before and after the intervention
Method of measurement
Caliper

8

Description
upper body strength
Timepoint
Before and after the intervention
Method of measurement
One repetition maximum chest press test

9

Description
Lower body strength
Timepoint
Before and after the intervention
Method of measurement
One repetition maximum leg press test

10

Description
Upper body muscular endurance
Timepoint
Before and after the intervention
Method of measurement
60% of one repetition maximum chest press test, repetitions until exhaustion

11

Description
Lower body muscular endurance
Timepoint
Before and after the intervention
Method of measurement
60% one repetition maximum leg press test, repetitions until fatigue

12

Description
aerobic power
Timepoint
Before and after the intervention
Method of measurement
Bruce's test

13

Description
anaerobic power
Timepoint
Before and after the intervention
Method of measurement
Sargent's jump test

14

Description
balance
Timepoint
Before and after the intervention
Method of measurement
One leg standing test

Intervention groups

1

Description
Intervention group: Spinning exercise + caffeine; Spinning training will be done by pedaling on special bikes for 8 weeks, 3 sessions a week, with an intensity of 40-85% of the maximum reserve heart rate, 30-40 minutes per session and with a resistance of 50-90 revolutions per minute. In order to comply with the overload principle, the intensity, duration and resistance of the bike will be increased once every two weeks. Caffeine powder at the rate of 5 mg/kg of body weight will be consumed 60 minutes before the start of the activity with a glass of water.
Category
Rehabilitation

2

Description
Control group: They will do their normal daily activities and will not practice spinning and consume caffeine or placebo.
Category
Other

3

Description
Intervention group: Spinning exercise + placebo; This group will perform the same spinning exercise as the Spinning + Caffeine group. But instead of caffeine, they will use capsules containing dextrose in the amount of 5 mg/kg 60 minutes before the activity as a placebo.
Category
Placebo

4

Description
intervention group: caffeine; This group will use capsules containing caffeine with a dose of 5 mg/kg along with a glass of water at the same hours and days as the other intervention groups.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Club Mahan and Club Nik
Full name of responsible person
Somayeh Rajabi
Street address
No. 126, 9th alley, Student St
City
Shahrood
Province
Semnan
Postal code
3614616575
Phone
+98 23 3233 4216
Email
rajabi_66_s@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Maryam Shahri
Street address
Islamic Azad University, Shahrood branch
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 4530
Email
shahri_rh17@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad University of Shahrood
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
Somayeh Rajabi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.9, Daneshjo Ave., Shahrood Town
City
Shahrood
Province
Semnan
Postal code
3614616575
Phone
+98 23 3233 4216
Fax
Email
S.rajabi@iau-shahrood.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Rajabi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.9, Daneshjo Ave., Shahrood Town
City
Shahrood
Province
Semnan
Postal code
3614616575
Phone
+98 23 3233 4216
Fax
Email
S.rajabi@iau-shahrood.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Rajabi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No.9, Daneshjo Ave., Shahrood Town
City
Shahrood
Province
Semnan
Postal code
3614616575
Phone
+98 23 3233 4216
Fax
Email
S.rajabi@iau-shahrood.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
Undecided - It is not yet known if there will be a plan to make this available
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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