]>
IRCT20261010071367N1 IRCT 2026-11-02 Shahid Beheshti University Effect of Exercise Training on Brain Changes During the Menopausal Transition women brain study Effects of Combined Exercise Training on Functional Brain Alterations During the Menopausal Transition: A Randomized Controlled Trial based on the Critical Window Hypothesis 2026-10-23 anticipated 60 Recruiting https://irct.ir/trial/93945 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: After confirming the inclusion criteria and obtaining written informed consent, participants are stratified into two strata—perimenopause and menopause—based on the STRAW+10 system. Subsequently, within each stratum, random allocation to either the combined exercise training group or the control group is performed at a 1:1 ratio. The randomization sequence is generated using Random Allocation software (version 1.0) with a block randomization method employing variable block sizes (4 and 6). Block sizes are selected randomly and unpredictably to prevent selection bias. To ensure allocation concealment, the randomization sequence is placed in opaque, sealed, and sequentially numbered envelopes. These envelopes are prepared by an individual independent of the research (who has no role in the enrollment and assessment of participants) and are opened only after complete enrollment of the participant, verification of eligibility, and signing of the consent form. Consequently, the enroller remains unaware of the upcoming allocation, thereby eliminating the possibility of selection bias. The randomization sequence is generated by an independent researcher who has no role in the enrollment and assessment of participants, and is placed in the numbered envelopes. Enrollment of participants is conducted by another researcher who is unaware of the contents of the envelopes. Final allocation to the groups is performed by the same independent researcher by opening the corresponding envelope after complete enrollment. N/A perimenopause: menopause. Intervention 1: The intervention group participates in a 16-week combined exercise program, three sessions per week (48 sessions in total, with at least 48 hours between sessions). Each session lasts 80 to 90 minutes, including 10 to 15 minutes of warm-up, 60 to 70 minutes of main exercise, and 10 minutes of cool-down. High-intensity interval training is performed on a cycle ergometer, progressively consisting of 6 to 12 bouts of 30 to 75 seconds at high intensity interspersed with 30 to 60 seconds of active recovery. Resistance training is performed as full-body training using gym machines, free weights, and body weight, with three separate weekly session routines and progressive intensity (RPE 7 to 10). The first two weeks are dedicated to familiarization and low-intensity continuous exercise. All sessions are supervised by trainers with heart rate monitoring. Equipment includes a cycle ergometer, resistance machines, free weights. Intervention 2: The control group receives no exercise intervention during the 16 weeks and is instructed to maintain usual lifestyle and avoid major changes in physical activity, diet, and supplement use. This group undergoes the same pre-test and post-test assessments as the training group. Yes - There is a plan to make this available What will be shared: De-identified individual participant data including all demographic, imaging, cognitive, functional, and questionnaire variables, along with the protocol and statistical analysis plan. Available from six months after publication of primary results for five years to qualified researchers. When: Access begins 6 months after publication of primary results and remains available for 5 years. To whom: Only researchers affiliated with accredited academic and scientific institutions, upon submission of a research proposal and signing a data sharing agreement; industry access is not permitted. Conditions: For meta-analysis, reproduction of results, and secondary analyses related to midlife women's brain health; upon submission of a research proposal, signing a no-re-identification agreement, prohibition of commercial use, source citation, and ethics approval. Where to obtain: To request data, applicants should contact the corresponding author, via email. How to obtain: Applicant submits request to the corresponding author's email; after review by the research team and ethics committee approval, the agreement is signed and data are transferred within 2–4 weeks. Comments:
public Elina Kiani Shahvandi
Shahid Beheshti University, Shahid Minoochehr Blvd., Shahid Shahriari Square, Evin Neighborhood, District 1, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1983969411 +98 21 29901 elina.kiani@yahoo.com Shahid Beheshti University scientific Elina Kiani Shahvandi
Shahid Beheshti University, Shahid Minoochehr Blvd., Shahid Shahriari Square, Evin Neighborhood, District 1, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1983969411 +98 21 29901 elina.kiani@yahoo.com Shahid Beheshti University Iran (Islamic Republic of) Iran (Islamic Republic of) Women aged 45 to 55 years. Being in perimenopause or menopause according to the STRAW+10 system. Having an intact and healthy uterus. Being in good health for physical activity based on PAR-Q+. No severe chronic or neurological diseases. No use of hormonal medications or specific supplements in the last 6 months. No regular exercise training in the past 6 months. Written informed consent to participate in the study. 45 years 55 years Female Diagnosis of neurodegenerative disease, cognitive impairment, or dementia. High risk of cardiac complications during exercise. Significant clinical neuropathy or severe musculoskeletal or joint disease that impairs mobility. Any hormone therapy (estrogen, androgen, or progesterone). Undergoing hysterectomy or endometrial ablation. Polycystic ovary syndrome (PCOS). Undergoing chemotherapy or having received chemotherapy in the past year. Premature ovarian failure. Absence from more than 15% of training sessions. Cardiac pacemaker, cardiac wires, or defibrillator. Presence of metal in the eye or orbital cavity. Steel clips for cerebral aneurysm. Intrauterine device made of stainless steel. Any surgery or tattooing (including cosmetic tattoos) within the past six weeks. History of radiotherapy or exposure to other high doses of radiation. Recurrent metastasis. Claustrophobia (fear of enclosed spaces). Artificial heart valve, ear implant. Implantable drug infusion pump. Nerve or bone electrical stimulator. Coil, catheter, or filter in any blood vessel. Orthopedic equipment (artificial joint, plate, screw, rod) or other metal parts in the body. N95 Menopausal and other perimenopausal disorders Lifestyle Lifestyle The intervention group participates in a 16-week combined exercise program, three sessions per week (48 sessions in total, with at least 48 hours between sessions). Each session lasts 80 to 90 minutes, including 10 to 15 minutes of warm-up, 60 to 70 minutes of main exercise, and 10 minutes of cool-down. High-intensity interval training is performed on a cycle ergometer, progressively consisting of 6 to 12 bouts of 30 to 75 seconds at high intensity interspersed with 30 to 60 seconds of active recovery. Resistance training is performed as full-body training using gym machines, free weights, and body weight, with three separate weekly session routines and progressive intensity (RPE 7 to 10). The first two weeks are dedicated to familiarization and low-intensity continuous exercise. All sessions are supervised by trainers with heart rate monitoring. Equipment includes a cycle ergometer, resistance machines, free weights. The control group receives no exercise intervention during the 16 weeks and is instructed to maintain usual lifestyle and avoid major changes in physical activity, diet, and supplement use. This group undergoes the same pre-test and post-test assessments as the training group. Functional brain changes measured by fALFF and FC indices. Timepoint: Pre-test (pre-intervention) and post-test (at the end of week 16 after intervention start). Method of measurement: Functional Magnetic Resonance Imaging. Cognitive performance (working memory, executive function, response inhibition, and processing speed). Timepoint: Pre-test (before the start of the intervention) and post-test (at the end of the sixteenth week following the start of the intervention). Method of measurement: Working memory: N-back test; executive function and response inhibition: Stroop test and processing speed; working memory: Digit Symbol subtest of the Wechsler Adult Intelligence Scale. Vasomotor Symptoms. Timepoint: Pre-test (before the start of the intervention) and post-test (at the end of the sixteenth week following the start of the intervention). Method of measurement: Hot Flash-Related Daily Interference Scale and Menopause Rating Scale. Physiological indicators (maximal oxygen consumption; body composition). Timepoint: Pre-test (before the start of the intervention) and post-test (at the end of the sixteenth week following the start of the intervention). Method of measurement: Maximal oxygen consumption will be measured using a maximal exercise test on a cycle ergometer via indirect spirometry; body composition will be assessed using an InBody body composition analyzer via the bioelectrical impedance analysis method. Force production-related indices (maximal voluntary contraction; rate of force development; fatigue index; grip strength). Timepoint: Pre-test (before the start of the intervention) and post-test (at the end of the sixteenth week following the start of the intervention). Method of measurement: Force-related parameters will be measured using a hand-grip dynamometer. Shahid Beheshti University Approved 2026-09-26 Biological Research Ethics Committee of Shahid Beheshti University Shahid Shahriari Square, Evin Tehran Tehran Iran (Islamic Republic of)