Protocol summary

Study aim
Comparison of the effects of eight weeks of traditional resistance training and high-intensity functional training on body composition, functional capacity, inflammatory markers (toll-like receptor 4, matrix metalloproteinase 9, interferon-gamma, interleukin-4), lipid profile, and fasting blood sugar in overweight men.
Design
Randomized controlled clinical trial with a parallel-group design, single-blind, phase 2, including 34 overweight male participants. Subjects were randomly allocated (using the RAND function in Excel) into three groups: Traditional Resistance Training (RT), High-Intensity Functional Training (HIFT), and control.
Settings and conduct
Study location: HealthLand Gym and Immunology Lab, School of Medicine, Isfahan University of Medical Sciences; Study population: 34 overweight men; Blinding type: Single-blind; Blinding method: Assessor and analyst were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy males; aged between 25 and 35 years; body mass index (BMI) between 25.0 and 29.9 kg/m²; no engagement in regular exercise during the past 6 months. Exclusion criteria: Use of specific medications or supplements within the past 6 months; history of cardiovascular disease; smoking within the past 6 months; weight gain of more than 2 kg during the past 6 months.
Intervention groups
Intervention group: High-Intensity Functional Training (HIFT) 3 weekly sessions for 8 weeks, functional high-intensity moves with 30s max effort and short rests. Intervention group: Traditional Resistance Training (RT) 3 weekly sessions for 8 weeks, 3 sets of 12 reps at 75% 1RM per session. Control group: No training, no intervention; only pre- and post-tests performed.
Main outcome variables
Toll-like receptor 4 (TLR4); matrix metalloproteinase-9 (MMP-9); interferon gamma (IFN-γ); interleukin-4 (IL-4); fasting blood sugar; total cholesterol; HDL; LDL; body composition; functional capacity.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170724035269N2
Registration date: 2025-05-27, 1404/03/06
Registration timing: retrospective

Last update: 2025-05-27, 1404/03/06
Update count: 0
Registration date
2025-05-27, 1404/03/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6111 8878
Email address
shabkhiz@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-05, 1401/05/14
Expected recruitment end date
2022-09-05, 1401/06/14
Actual recruitment start date
2022-08-05, 1401/05/14
Actual recruitment end date
2022-09-05, 1401/06/14
Trial completion date
2022-09-20, 1401/06/29
Scientific title
Comparison of the effects of traditional resistance training and high-intensity functional training on toll-like receptor 4, matrix metalloproteinase 9, interleukin 4, interferon-gamma, lipid profile, muscular strength, and aerobic capacity in overweight men
Public title
Effect of training on inflammatory markers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 and 35 years. Healthy overweight men (BMI between 25 and 29.9 kg/m²). No participation in regular and organized exercise programs in the last six months. Completion of informed consent form and medical health questionnaire.
Exclusion criteria:
Smoking during the past 6 months. Weight gain of more than 2 kg in the last 6 months. Participation in a weight loss program during the past 6 months. Engagement in heavy resistance training aimed at increasing muscle mass and strength during the past 6 months. Presence of chronic metabolic or endocrine diseases. Family history of early cardiac mortality. Inability to complete the exercise protocol (identified during the pilot phase). Use of any specific medication or supplement in the past six months History of cardiovascular diseases
Age
From 25 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 39
Actual sample size reached: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description: This study utilized simple randomization. Eligible participants were randomly assigned to one of the three groups: traditional resistance training (RT), high-intensity functional training (HIFT), or control (CON). Unit of randomization: The unit of randomization was at the individual level. Stratified randomization layers: No stratified randomization was used. Randomization tool: The randomization sequence was generated using a random number table and G-Power statistical software. How the random sequence was created: The random allocation sequence was created by a researcher who was not involved in the intervention, using a random number table, and the participants were assigned accordingly. Allocation concealment: To prevent selection bias, allocation codes were sealed in opaque, sealed envelopes. The intervention supervisor was blinded to group assignments until the moment of allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the nature of the interventions, participants were blinded to their group assignment and the primary aim of the intervention. Additionally, to minimize bias during data collection and analysis, biological sample collectors, laboratory analysts, and the data statistician were blinded to group allocations. Detailed description: Participants: Blinded to group assignment and the primary study hypothesis. Principal investigator and intervention supervisors: Aware of group allocations to manage the exercise sessions. Healthcare/sports personnel (trainers/supervisors): Not blinded. Sample collectors and laboratory staff: Blinded to group assignments. Data analyst/statistician: Analyzed coded data without knowledge of group allocation. Manuscript authors: Informed of group assignments only after the completion of data collection. Accordingly, the study is classified as a Single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of the Faculty of Physical Education and Sport Sciences, University of Teh
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Opposite of Tehran University Dormitory, Between 15th and 16th Streets, North Kargar Street, Above Jalal Al-Ahmad Crossroad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417935840
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.UT.SPORT.REC.1401.025

Health conditions studied

1

Description of health condition studied
Overweight
ICD-10 code
E66.3
ICD-10 code description
Overweight

2

Description of health condition studied
Dyslipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified

3

Description of health condition studied
Low-grade systemic inflammation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood level of toll-like receptor 4 (TLR4)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit

2

Description
Blood level of matrix metalloproteinase 9 (MMP-9)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit

3

Description
Blood level of interferon-gamma (IFN-γ)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit

4

Description
Blood level of interleukin-4 (IL-4)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit

5

Description
Fasting blood sugar (FBS)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzymatic method using an automatic biochemistry analyzer

6

Description
Total cholesterol (CHOL)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzymatic method using an automatic biochemistry analyzer

7

Description
High-density lipoprotein cholesterol (HDL)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzymatic method using an automatic biochemistry analyzer

8

Description
Low-density lipoprotein cholesterol (LDL)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzymatic method using an automatic biochemistry analyzer

9

Description
Triglycerides
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by enzymatic method using an automatic biochemistry analyzer

10

Description
Change in body composition (body fat percentage and lean mass)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by bioelectrical impedance analysis using InBody 270 device

11

Description
Change in functional capacity (based on functional performance tests)
Timepoint
At baseline (before the start of the intervention) and After completing the 8-week intervention period
Method of measurement
Measured by one-repetition maximum test in bench press exercise and indirect estimation of maximal oxygen consumption (VO2max) using a treadmill test.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1 (High-Intensity Functional Training):Three sessions per week for 8 weeks. Each session included 4 bouts of functional exercises (squat, deadlift, shoulder press, bench press, and row) performed for 30 seconds at maximum effort using a barbell. Rest intervals were 30 seconds between exercises and 2.5 minutes between bouts. Training was supervised by an exercise physiologist at HealthLand Gym.
Category
Lifestyle

2

Description
Intervention group 2 (Traditional Resistance Training):Three sessions per week for 8 weeks. Each session involved traditional resistance exercises (squat, deadlift, bench press, shoulder press, and row) using weight machines and barbells. Participants performed 3 sets of 12 repetitions at 75% of 1RM. Sessions were conducted at HealthLand Gym under supervision.
Category
Lifestyle

3

Description
Control group:No intervention during the 8-week period; only participated in pre- and post-tests.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Land Gym, Isfahan
Full name of responsible person
Shervin Abedi
Street address
HealthLand Sports Complex, Shahidan Sharqi St., Khoram St., Jomhouri Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۳۶۳۴۵۷۱
Phone
+98 31 3335 7152
Email
shervin.7290@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faculty of Physical Education and Sport Sciences, University of Tehran
Full name of responsible person
Seyed Hamed Mousavi
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Opposite Tehran University Dormitory, Between 15th and 16th Streets, North Kargar Street, Above Jalal Al-Ahmad Crossroad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۶۶۱۹۱
Phone
+98 21 6111 8807
Email
musavihamed@ut.ac.ir
Web page address
https://profile.ut.ac.ir/~musavihamed/courses
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Physical Education and Sport Sciences, University of Tehran
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
Faculty of Physical Education and Sport Sciences, University of Tehran
Full name of responsible person
Fatemeh Shabkhiz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, opposite the University of Tehran Dormitory, between 15th and 16th Streets, above Jalal Al-Ahmad Crossroad, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۶۶۱۹۱
Phone
+98 21 6111 8878
Email
shabkhiz@ut.ac.ir
Web page address
https://profile.ut.ac.ir/~shabkhiz

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Physical Education and Sport Sciences, University of Tehran
Full name of responsible person
Fatemeh Shabkhiz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, opposite the University of Tehran Dormitory, between 15th and 16th Streets, above Jalal Al-Ahmad Crossroad, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۶۶۱۹۱
Phone
+98 21 6111 8878
Email
shabkhiz@ut.ac.ir
Web page address
https://profile.ut.ac.ir/~shabkhiz

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Physical Education and Sport Sciences, University of Tehran
Full name of responsible person
Fatemeh Shabkhiz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, opposite the University of Tehran Dormitory, between 15th and 16th Streets, above Jalal Al-Ahmad Crossroad, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۶۶۱۹۱
Phone
+98 21 6111 8878
Email
shabkhiz@ut.ac.ir
Web page address
https://profile.ut.ac.ir/~shabkhiz

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
Data related to toll-like receptor 4 (TLR4), matrix metalloproteinase 9 (MMP-9), interferon-gamma (IFN-γ), interleukin 4 (IL-4), fasting blood sugar (FBS), lipid profile (cholesterol, HDL, LDL), and body composition of participants. Details: The individual data includes laboratory results and physical measurements (using standard devices). All data will be shared after de-identifying the participants (removal of names and identifying information). Data related to primary outcomes (inflammatory markers and lipid profile) will be available for sharing. Only personal identifiable data or confidential information will be excluded from sharing.
When the data will become available and for how long
Access to the data will start six months after the publication of the study results. The access period will continue for three years after the starting date.
To whom data/document is available
The data will be available only to researchers affiliated with academic and research institutions who submit an official request. Individuals working in industry or private companies will not have access to the data.
Under which criteria data/document could be used
The data may only be used for scientific and research analyses. Commercial use or publication without prior written permission is prohibited. Applicants must submit an official request including a description of the research purpose and the intended analyses. A confidentiality agreement must be signed by the applicants. Access will be granted only after approval by the research committee.
From where data/document is obtainable
Applicants must contact Dr. Fatemeh Shabkhiz exclusively to request access to the data. All requests must be formally submitted via email to: fatemeh.shabkhiz@ut.ac.ir For postal correspondence, requests should be sent to: Faculty of Physical Education and Sport Sciences, University of Tehran, North Kargar Street, above Jalal Al-Ahmad intersection, between 15th and 16th Streets, opposite the University of Tehran dormitory, Tehran, Postal Code: 1417466191.
What processes are involved for a request to access data/document
After submitting a formal request to Dr. Fatemeh Shabkhiz, the request will be reviewed within 10 working days. If approved by the research committee, the applicant must sign a data confidentiality agreement. After signing the agreement, the data will be provided to the applicant within a maximum of 15 working days. If the request is rejected, the reason for rejection will be formally communicated to the applicant.
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