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IRCT20260520069464N1 IRCT 2026-05-25 Islamic Azad University The effect of ten weeks of intense and short-term exercise on the heart health of obese elderly women The effect of ten weeks of Tabata resistance training on structural and functional changes in the heart of obese elderly women 2026-05-28 anticipated 36 Recruiting https://irct.ir/trial/90287 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization unit in this study is the individual. After being called and screened based on the inclusion criteria, volunteers are individually assigned to the allocation process. Simple randomization will be used to divide the subjects into two groups: Tabata and control. The sequence of this allocation will be generated by a statistician using SPSS statistical software so that each individual has an equal chance of being placed in each group. Stratification will not be used in this study. To conceal allocation and prevent bias, opaque, sealed, serially numbered envelopes are used. The names of the groups are placed on cards in the software sequence and placed inside these envelopes. These envelopes are opened by someone outside the implementation team only after initial measurements, including weight and body composition indices, have been taken. This process ensures that neither the researcher nor the subject is aware of the type of group assigned until the exercises begin, Blinding description: In this study, in order to comply with the principles of double blinding, participants and the outcome assessor (echocardiography specialist) will be unaware of the type of group assignment. Participants are not aware of the main hypotheses of the study and the type of group division. Also, the specialist physician responsible for performing echocardiography will not be aware of which subject is in the Tabata exercise group and which is in the control group. For this purpose, subjects are referred to the physician without mentioning the group name and only with a protocolized identification code to prevent bias in the evaluation and interpretation of the results. N/A Structural and functional cardiac changes in obese elderly women.. Intervention 1: Intervention group: Performing high-intensity interval training based on the Tabata protocol for ten weeks and three sessions per week. Each training session includes six minutes of warm-up with stretching exercises, Twenty to thirty minutes of the main exercise block (consisting of eight rounds of twenty seconds of activity at ninety to ninety-five percent of maximum heart rate and ten seconds of active rest between each round), and finally, six minutes of cool-down. The exercises include functional movements tailored to the ability of elderly women (such as half-squats, fast marching, and knee-ups) conducted under the supervision of an exercise physiologist. Intervention 2: Control group: Subjects in this group do not receive any exercise intervention or organized training program during the ten-week study period. These individuals are requested to maintain their usual level of daily activities and lifestyle habits throughout the research period and not to participate in any organized physical activity program. Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Dataset and Study Documents for the Trial: Effects of 10-Week Tabata Resistance Training on Left Ventricular Mass and Cardiac Dimensions in Obese Older Women. All individual participant data (IPD) related to primary outcomes and secondary outcomes will be available for sharing after the completion of the study and publication of the main manuscript. To adhere to ethical principles, all personal identifiers (such as names, national IDs, and contact information) will be completely removed, and the data will be shared in a de-identified Excel format to ensure participant confidentiality. When: Data and document access will begin 6 months after the publication of the final results and the main manuscript, and will be available for a period of 2 years. To whom: Access to the data and documents of this study will be granted only to researchers and investigators affiliated with academic and scientific institutions, as well as graduate students conducting related research in sports science or cardiovascular fields. Conditions: The data and documents of this study are available solely for secondary statistical analysis, systematic reviews, and meta-analyses to advance knowledge in sports science and cardiovascular physiology. Any commercial use or advertising purposes are strictly prohibited. Applicants are required to provide a formal citation to the original study in any resulting scientific work. Furthermore, the data must not be shared with third parties. Requirements for submitting a request include an official letter of introduction from the affiliated university or institution, a brief proposal outlining the intended use of the data, and a commitment to maintaining confidentiality and avoiding any attempts at participant re-identification. Where to obtain: Applicants should submit their requests for data or documents through the following channels in order of priority: First Priority (Email): Send the request to the Corresponding Author's email at info@iauk.ac.ir (or the specific academic email provided in the final published paper). The subject line must include "Request for IPD - Tabata Training Clinical Trial". Second Priority (In-person or Postal Mail): Department of Physical Education and Sport Sciences, Islamic Azad University of Kerman, Imam Ali Boulevard, Kerman, Iran. Contact Person: Corresponding Author and Head of the Department of Physical Education and Sport Sciences, Islamic Azad University of Kerman. How to obtain: Applicants must follow the process below to access the data or documents: 1. Formal Request Submission: The applicant must send an email containing a valid letter of introduction from their university or institution, along with a brief proposal (purpose of use), to the corresponding author. 2. Initial Review: The corresponding author will review the request for ethical and scientific compliance within 7 working days and provide an initial response. 3. Signing the Agreement: If approved, a Non-Disclosure Agreement (NDA) and confidentiality form will be sent to the applicant, which must be signed and returned (approximately 3 to 5 days). 4. Preparation and Delivery: After receiving the signed agreement, the anonymized data and requested documents will be sent to the applicant as encrypted files within 7 days. Comments:
public Ahad Shafiei
Department of Physical Education and Sport Sciences, Islamic Azad University, Kerman Branch., Emam ali Blvd., kerman Town
Kerman Iran (Islamic Republic of) 7635168111 +98 34 3321 0043 Shafiee.sport@gmail.com Islamic Azad University scientific Ahad Shafiei
Department of Physical Education and Sport Sciences, Islamic Azad University, Kerman Branch., Emam ali Blvd., kerman Town
Kerman Iran (Islamic Republic of) 7635168111 +98 34 3321 0043 Shafiee.sport@gmail.com Islamic Azad University Iran (Islamic Republic of) Body mass index in the overweight or obese range Physical activity less than 150 minutes of exercise per week in the past 6 months Physical and mental health certified by a medical professional 55 years 65 years Female Participation in regular exercise or resistance training in the past year Use of sports supplements or steroid medications Smoking History of pain or surgery in the musculoskeletal area Suffering from cardiovascular disease or limiting systemic diseases Lifestyle Lifestyle Intervention group: Performing high-intensity interval training based on the Tabata protocol for ten weeks and three sessions per week. Each training session includes six minutes of warm-up with stretching exercises, Twenty to thirty minutes of the main exercise block (consisting of eight rounds of twenty seconds of activity at ninety to ninety-five percent of maximum heart rate and ten seconds of active rest between each round), and finally, six minutes of cool-down. The exercises include functional movements tailored to the ability of elderly women (such as half-squats, fast marching, and knee-ups) conducted under the supervision of an exercise physiologist. Control group: Subjects in this group do not receive any exercise intervention or organized training program during the ten-week study period. These individuals are requested to maintain their usual level of daily activities and lifestyle habits throughout the research period and not to participate in any organized physical activity program. Left Ventricular Mass (LVM) measured by 2D echocardiography in grams. Timepoint: Measurement at the beginning of the study (baseline), at the end of the 10th week (24 hours after the last session of the meeting), and 4 weeks after the end of the intervention (follow-up phase). Method of measurement: Using a two-dimensional echocardiography device based on the American Society of Echocardiography standard formulas by a cardiologist. Left Ventricular End-Systolic Dimension (LVESD). Timepoint: Measurement at the beginning of the study (before starting the exercises), at the end of the tenth week (24 hours after the last session of the meeting), and four weeks after the completion of the training period (follow-up phase). Method of measurement: 2D Echocardiography. Left Ventricular End-Diastolic Dimension (LVEDD). Timepoint: Measurement at the beginning of the study (before starting the exercises), at the end of the tenth week (24 hours after the last session of the meeting), and four weeks after the completion of the training period (follow-up phase). Method of measurement: 2D Echocardiography. Islamic Azad University, Kerman Branch Approved 2026-05-06 Ethics committee of Islamic Azad University, Kerman branch No. 5, Alley 21., Emam Khomeini Blvd., Bam Town Bam Kerman Iran (Islamic Republic of)