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Hormonal, Lactate, and Cardiac Autonomic Responses to Resistance Exercise with and Without Blood Flow Restriction at Menstrual Cycle Phases in Trained Women

Protocol summary

Study aim
Investigating the effect of resistance exercise (with and without blood flow restriction) in different phases of menstrual cycle
Design
The study will be conducted using a cross-over design on one group of participants and two types of resistance exercises (with and without blood flow restriction), in follicular and luteal phases of menstrual cycle, on 12 trained women
Settings and conduct
This study will be conducted in the University of Guilan sports physiology laboratory. participants will perform 4 sessions of resistance exercises ( 2 sessions of traditional resistance exercise with 70%1RM and 2 sessions of resistance exercise with blood flow restriction and 30%1RM with 60% of limb occlusion pressure, in two consecutive menstrual cycles in luteal and follicular phases. Blood samples will be collected before and after the exercise.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Trained women with at least six months of regular resistance training experience, Regular menstrual cycles (28–32 days) and Range of age between 20 to 30 years; Exclusion criteria: Taking hormonal medications or oral contraceptives during the past six months, Consumption of nutritional supplements or caffeine at least 48 hours prior to testing and The history of cardiovascular, metabolic, endocrine, or neurological diseases
Intervention groups
Each participant completes two intervention conditions: resistance exercise without blood flow restriction at 70% of one-repetition maximum (leg press and knee extension; 4×10 with 1-minute rest) and resistance exercise with blood flow restriction at 30% of one-repetition maximum (at 60% limb occlusion pressure; the same exercises in four sets: 30 repetitions in the first set and three sets of 15 repetitions with 1-minute rest).
Main outcome variables
Growth hormone, Cortisol, Blood Lactate, Heart Rate Variability, Rating of Perceived Exertion (RPE)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251202068190N1
Registration date: 2026-04-11, 1405/01/22
Registration timing: retrospective

Last update: 2026-04-11, 1405/01/22
Update count: 0
Registration date
2026-04-11, 1405/01/22
Registrant information
Name
Zahra Aftabi Talami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 1360
Email address
zahraaftabi.t@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-17, 1404/03/27
Expected recruitment end date
2025-07-30, 1404/05/08
Actual recruitment start date
2025-06-17, 1404/03/27
Actual recruitment end date
2025-07-27, 1404/05/05
Trial completion date
2025-07-27, 1404/05/05
Scientific title
Hormonal, Lactate, and Cardiac Autonomic Responses to Resistance Exercise with and Without Blood Flow Restriction at Menstrual Cycle Phases in Trained Women
Public title
The effect of resistance exercise with and without blood flow restriction during different phases of the menstrual cycle in trained women
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Trained women with at least six months of regular resistance training experience Regular menstrual cycles (28–32 days) Range of age between 20 to 30 years
Exclusion criteria:
Taking hormonal medications or oral contraceptives during the past six months Consumption of nutritional supplements or caffeine at least 48 hours prior to testing The history of cardiovascular, metabolic, endocrine, or neurological diseases
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 12
More than 1 sample in each individual
Number of samples in each individual: 8
Pre and post test blood samples in Traditional Resistance Exercise in the luteal phase, Traditional Resistance Exercise in the follicular phase, Resistance Exercise with Blood Flow Restriction in the luteal phase and Resistance Exercise with Blood Flow Restriction in the follicular phase. (one group of participants will perform 4 sessions of exercise and the samples will be measured before and after each session; pre-post test)
Actual sample size reached: 12
More than 1 sample in each individual
Actual sample size in each individual: 8
Pre and post test blood samples in Traditional Resistance Exercise in the luteal phase, Traditional Resistance Exercise in the follicular phase, Resistance Exercise with Blood Flow Restriction in the luteal phase and Resistance Exercise with Blood Flow Restriction in the follicular phase. (one group of participants will perform 4 sessions of exercise and the samples will be measured before and after each session; pre-post test)
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Guilan
Street address
University of Guilan, 5th Kilometer of Rasht-Qazvin road, Rasht, Guilan province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Approval date
2025-04-14, 1404/01/25
Ethics committee reference number
IR.GUILAN.REC.1404.019

Health conditions studied

1

Description of health condition studied
Menstrual cycle status
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Growth hormone
Timepoint
Pre-test (before the exercise session) and post-test (after the test/end of the exercise session)
Method of measurement
Serum growth hormone concentration will be measured through blood sampling and laboratory assessment using the Enzyme-Linked Immunosorbent Assay (ELISA) method.

2

Description
Cortisol
Timepoint
Pre-test (before the exercise session) and post-test (after the test/end of the exercise session).
Method of measurement
Serum cortisol concentration will be measured using blood sampling and laboratory analysis by the enzyme-linked immunosorbent assay (Enzyme-Linked Immunosorbent Assay).

3

Description
Blood Lactate
Timepoint
Pre-test (before the exercise session) and post-test (after the test/end of the exercise session).
Method of measurement
Plasma lactate level will be measured using blood sampling and laboratory analysis by a standard enzymatic method.

4

Description
Heart Rate Variability
Timepoint
Heart rate variability will be recorded and analyzed in 5-minute time windows during the pre-test period and immediately after the test.
Method of measurement
Heart rate variability will be measured and analyzed using a Polar H10 heart rate sensor.

Secondary outcomes

1

Description
Blood Pressure
Timepoint
Pre-test (before the exercise session) and post-test up to 60 minutes after the test.
Method of measurement
By using Sphygmomanometer

2

Description
Rating of Perceived Exertion (RPE)
Timepoint
Immediately after completion of each set of the exercise
Method of measurement
By using the Borg rating of perceived exertion scale

Intervention groups

1

Description
Control group: Resistance exercise without Blood Flow Restriction; Participants will perform traditional resistance exercise at an intensity of 70% of one-repetition maximum (1RM). The training protocol will include of two exercises, leg press and leg extension, each will be performed for 4 sets of 10 repetitions. Rest intervals will consist of 1 minute between sets and 2-3 minutes between two exercises. The intervention will be conducted over two consecutive menstrual cycles, such that one session will be performed during the follicular phase and one session during the luteal phase.
Category
Diagnosis

2

Description
Intervention group: Resistance exercise with Blood Flow Restriction (BFR); Participants in this group will perform resistance exercises (leg press and leg extension) at an intensity of 30% of 1RM. BFR will be applied using a cuff placed at the proximal portion of the lower limb, with a pressure set at 60% of Limb Occlusion Pressure (LOP). The training protocol will consist of 4 sets (30-15-15-15 repetition), with one minute of rest between sets and 2-3 minutes between two exercises. The intervention will be conducted over two consecutive menstrual cycles, such that one session will be performed during the follicular phase and one session during the luteal phase.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Guilan
Full name of responsible person
Javad Mehrabani
Street address
University of Guilan, 5th Kilometer of Rasht-Qazvin road, Rasht, Guilan province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0685
Email
mehrabanij@guilan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Guilan
Full name of responsible person
Ali Bani
Street address
University of Guilan, 5th Kilometer of Rasht-Qazvin road, Rasht, Guilan province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0685
Email
bani@guilan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Guilan
Proportion provided by this source
100
Public or private sector
Public
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
University of Guilan
Full name of responsible person
Zahra Aftabi Talami
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University of Guilan, 5th Kilometer of Rasht-Qazvin road, Rasht, Guilan province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0685
Email
zahraaftabi.t@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Javad Mehrabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
University of Guilan, 5th Kilometer of Rasht-Qazvin road, Rasht, Guilan province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0685
Email
Mehrabanij@guilan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Zahra Aftabi Talami
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University of Guilan, 5th Kilometer of Rasht-Qazvin road, Rasht, Guilan province, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0685
Email
zahraaftabi.t@gmail.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
This document includes a complete description of the study design, training protocol, intervention schedule, measurement methods for all variables, and study procedures, prepared to enhance transparency and reproducibility of the results.
When the data will become available and for how long
After publication of the study results
To whom data/document is available
Researchers and the academic staff
Under which criteria data/document could be used
The data are available solely for research purposes, subject to confidentiality requirements and approval by the principal investigator.
From where data/document is obtainable
Through the principal investigator.
What processes are involved for a request to access data/document
Email of the principal investigator
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