The Effect of Two Types of Resistance Training With and Without Blood Flow Restriction on Selected Pro-inflammatory Cytokines in Overweight Men
Design
This clinical trial is a controlled, parallel-group study with single-blind design. A total of 50 participants were randomly allocated into five groups:
Resistance Training 1 (RT1) group (n=10),
Resistance Training 2 (RT2) group (n=10),
Resistance Training 1 with Blood Flow Restriction (RT1+BFR) group (n=10),
Resistance Training 2 with Blood Flow Restriction (RT2+BFR) group (n=10),
and a Control group (n=10).
Settings and conduct
The statistical population of this quasi-experimental study consisted of overweight men aged 20 to 30 years old, with no prior history of regular physical activity, residing in the city of Ardabil. The intervention period lasted six weeks. Following the pre-test phase and the commencement of the training program, participants were assigned to separate groups and performed two different types of resistance exercise protocols. The resistance exercises were conducted both with and without blood flow restriction. After completion of the training period, all measurements related to the outcome variables were repeated under the same conditions during a post-test session. Outcome assessors were blinded to group allocation to minimize measurement bias.
Participants/Inclusion and exclusion criteria
Age between 20 and 30 years, being overweight, having no history of chronic diseases, and not using medications or tobacco products.
Intervention groups
Resistance Training 1 (RT1),
Resistance Training 2 (RT2),
Resistance Training 1 with Blood Flow Restriction (RT1+BFR),
Resistance Training 2 with Blood Flow Restriction (RT2+BFR),
Control group.
Main outcome variables
TNF-a، IL-1b، (IL-6 )
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190831044649N2
Registration date:2025-09-20, 1404/06/29
Registration timing:retrospective
Last update:2025-09-20, 1404/06/29
Update count:0
Registration date
2025-09-20, 1404/06/29
Registrant information
Name
Ali Barzegari
Name of organization / entity
Payame noor university
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 0048
Email address
ali_barzegari@pnu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2025-08-06, 1404/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two types of resistance training with and without blood flow restriction on some pro-inflammatory cytokines in overweight men
Public title
The effect of two types of training with and without blood flow restriction on some cytokines in men
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The subjects' age should be between 20 and 30 years old.
Subjects are overweight.
Subjects should not have a history of any specific illness.
Not using drugs and tobacco
Exclusion criteria:
Age outside the defined range of 20 to 30 years.
Body Mass Index (BMI) outside the defined overweight range or severe obesity (BMI ≥ 35 kg/m²).
History of uncontrolled cardiovascular, respiratory, renal, hepatic, or metabolic diseases
Use of medications known to significantly affect metabolism, inflammation, or immune function
Regular structured physical activity or exercise training within the past 3 months.
Tobacco smoking or alcohol consumption within the past 6 months.
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants (n=50), who were screened based on the inclusion and exclusion criteria, were randomly assigned to one of the five study groups. To ensure genuine random allocation, a standard randomization procedure, such as using a random number table, was employed. This process was conducted in a manner that prevented the researchers from predicting which group a subsequent participant would be assigned to, thereby minimizing selection bias.
To guarantee an equal number of participants across all groups (10 per group), a blocked randomization method was utilized. In this technique, a fixed block size (e.g., 5 or 10) was defined, and the sequence of assignments within each block was generated randomly. This approach ensures that at the end of the recruitment period, the number of participants in all groups is precisely balanced.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention (resistance exercise training), implementation of double blinding was not feasible in this study. Participants were explicitly aware of their assigned group (resistance training with or without blood flow restriction), and trainers as well as researchers were necessarily informed about the type of intervention being administered.
However, to enhance methodological rigor and minimize potential bias:
Independent assessors , responsible for measuring outcome variables such as BMI and other anthropometric indices, were blinded to participants’ group allocations (single blinding ).
Statistical analyses were conducted by data analysts who remained unaware of the group assignments throughout the analytical process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Payam Noor University
Street address
Tehran, Mini City, Artesh Blvd., 1st Oil City, Nakhl St., Central Organization of Payam Noor University
City
Tehran
Province
Tehran
Postal code
19395-4697
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.PNU.REC.1401.285
Health conditions studied
1
Description of health condition studied
overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
TNF-a
Timepoint
two stages: pre-test and post-test
Method of measurement
Sandwich ELISA kit
2
Description
IL-1b
Timepoint
two stages: pre-test and post-test
Method of measurement
Sandwich ELISA kit
3
Description
IL-6
Timepoint
two stages: pre-test and post-test
Method of measurement
Sandwich ELISA kit
Secondary outcomes
1
Description
Descriptive Indice: Height
Timepoint
pre-test
Method of measurement
Height was measured using a wall-mounted stadiometer (Model: Seca 213, Germany) with a measurement unit of centimeters (cm) and an instrument precision of 0.1 cm.
2
Description
Weight
Timepoint
In two stages: pre-test and post-test
Method of measurement
Body weight was measured using a calibrated digital scale (Model: Seca 813, Germany) with a precision of 0.1 kg.
3
Description
Body Mass Index (BMI)
Timepoint
In two stages: pre-test and post-test
Method of measurement
Body Mass Index (BMI) is a derived anthropometric measure calculated from direct measurements of body weight and height.
Intervention groups
1
Description
Group 1: Resistance Training with Elastic BandsParticipants in this group performed a resistance training program using TheraBand elastic bands for 6 weeks, with 3 sessions per week (total of 18 sessions). Each session consisted of 10 minutes of warm-up, 25–35 minutes of main exercise, and 5 minutes of cool-down. The training protocol began with 2 sets of 8 repetitions at ∼60% of 1RM and progressively increased to 3 sets of 10 repetitions at ∼75% of 1RM by the sixth week. The exercises included 6 movements (3 upper-body and 3 lower-body). Active rest periods of 60 seconds were implemented between sets.
Category
Other
2
Description
Group 2: Resistance Training with DumbbellsThis group performed a resistance training program using adjustable dumbbells for 6 weeks, with 3 sessions per week. The session structure was identical to that of Group 1. The protocol included 12 exercises (6 upper-body and 6 lower-body) performed on alternating days. Training intensity started at 2 sets of 8 repetitions at 60% of 1RM and progressed to 3 sets of 10 repetitions at 75% of 1RM by the sixth week. Active rest intervals of 60 seconds were maintained between sets.
Category
Other
3
Description
Group 3: Resistance Training with Elastic Bands + Blood Flow Restriction (BFR)The training protocol for this group was identical to that of Group 1 but was combined with blood flow restriction (BFR). Specialized rubber tourniquets (width: 3–5 cm) were applied to the proximal portion of the limbs. The tourniquet pressure was calibrated using Doppler ultrasonography to ensure complete arterial occlusion. The tourniquets remained inflated throughout the entire session (including rest intervals) and were deflated only after the session concluded. The procedure was supervised by a medical professional to ensure safety.
Category
Other
4
Description
Group 4: Resistance Training with Dumbbells + Blood Flow Restriction (BFR)The training protocol for this group was identical to that of Group 2 but was combined with blood flow restriction (BFR). The BFR application protocol (tourniquet type, pressure, and supervision) was identical to that used in Group 3. Participants performed dumbbell exercises at the same volume and intensity as Group 2, with simultaneous application of BFR.