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IRCT20261005071304N1 IRCT 2026-10-08 Islamic Azad University The Effect of Combined Training on Muscular Changes in Older Women The effect of combined exercises on the levels of some factors related to muscle hypertrophy in elderly women 2026-10-23 anticipated 30 Complete https://irct.ir/trial/93861 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The study population consists of elderly women who visit the elderly care center during the designated research period. A convenience sampling method is employed for participant selection. Following the selection of 30 participants based on the study's inclusion and exclusion criteria, they will be randomly assigned to either the "combined exercises" group (intervention group) or the "waiting list" group (control group). Randomization will be performed using a block randomization method with variable block sizes (4 and 6) by an independent statistician who is not involved in the study's implementation. The randomization schedule will be generated using the RAND function in Excel and subsequently placed in numbered, opaque, sealed envelopes to ensure that neither the researcher nor the participants are aware of the allocation sequence (allocation concealment). The envelopes will be opened—and the assigned group revealed—only at the time each participant enters the study. To ensure the comparability of baseline variables (such as age), their distribution across the two groups will be assessed during the statistical analysis phase. N/A Physiological changes in aging. Intervention 1: Intervention group: The intervention consists of an 8-week combined exercise program (Pilates and fitness). Each session begins with a 10-minute warm-up (comprising preparatory movements, breathing exercises, and spinal mobility drills). This is followed by 30 minutes of Pilates exercises performed in standing, seated, and supine positions, aimed at improving flexibility, balance, and neuromuscular coordination. The intensity of the Pilates exercises is gradually increased based on heart rate reserve (Karvonen method), rising from 50–55% in the first week to 65–70% by the eighth week. After a 5-minute rest, fitness (resistance) exercises are performed to enhance physical fitness and promote hypertrophy. Adhering to the principle of progressive overload, exercise intensity is gradually increased from a 20-repetition maximum (RM) load during the first two weeks to a 10-RM load by the seventh and eighth weeks. All exercises are performed to the point of voluntary exhaustion, and participants' heart rates are monitored using an electronic heart rate monitor to ensure precise control of exercise intensity. Intervention 2: Control group: The control group will not receive any type of intervention during the implementation of the research, but to avoid factors that threaten the internal validity of the research, such as compensatory competition of the control group or demoralization, they will receive the intervention after data collection. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is As the research has not yet commenced and no data is available, it is not possible to publish any data. I will proceed with the publication of the data once these issues are resolved.
public Samaneh Fazilat
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
Ahvaz Iran (Islamic Republic of) 6134937333 +98 61 3334 8421 Fazilatsamane1@gmail.com Islamic Azad University scientific Samaneh Fazilat
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
Ahvaz Iran (Islamic Republic of) 6134937333 +98 61 3334 8421 Fazilatsamane1@gmail.com Islamic Azad University Iran (Islamic Republic of) Women over the age of 60instructions Sedentary lifestyle and lack of regular physical activity Absence of musculoskeletal disorders Achieving a normal score on a cognitive screening test to ensure comprehension of exercise 60 years no limit Female A history of heart attack, heart failure, or uncontrolled high blood pressure Acute or chronic joint or spinal injuries that prevent the performance of resistance or combined exercises Use of medications that directly affect muscle metabolism or muscle growth Presence of progressive neurological disorders Z00.6 Encounter for examination for normal comparison and control in clinical research program Prevention Prevention Intervention group: The intervention consists of an 8-week combined exercise program (Pilates and fitness). Each session begins with a 10-minute warm-up (comprising preparatory movements, breathing exercises, and spinal mobility drills). This is followed by 30 minutes of Pilates exercises performed in standing, seated, and supine positions, aimed at improving flexibility, balance, and neuromuscular coordination. The intensity of the Pilates exercises is gradually increased based on heart rate reserve (Karvonen method), rising from 50–55% in the first week to 65–70% by the eighth week. After a 5-minute rest, fitness (resistance) exercises are performed to enhance physical fitness and promote hypertrophy. Adhering to the principle of progressive overload, exercise intensity is gradually increased from a 20-repetition maximum (RM) load during the first two weeks to a 10-RM load by the seventh and eighth weeks. All exercises are performed to the point of voluntary exhaustion, and participants' heart rates are monitored using an electronic heart rate monitor to ensure precise control of exercise intensity. Control group: The control group will not receive any type of intervention during the implementation of the research, but to avoid factors that threaten the internal validity of the research, such as compensatory competition of the control group or demoralization, they will receive the intervention after data collection. Body Mass Index. Timepoint: Phase 1: 48 hours prior to the start of the intervention. Phase 2: 72 hours after the final training session, to avoid the acute effects of exercise on the variables. Method of measurement: By means of a calculation involving dividing weight in kilograms by the square of height in meters. Body Fat Percentage. Timepoint: Phase 1: 48 hours prior to the start of the intervention. Phase 2: 72 hours after the final training session, to avoid the acute effects of exercise on the variables. Method of measurement: Using the bioimpedance method. Myostatin. Timepoint: Phase 1: 48 hours prior to the start of the intervention. Phase 2: 72 hours after the final training session, to avoid the acute effects of exercise on the variables. Method of measurement: Using an ELISA kit. Follistatin. Timepoint: Phase 1: 48 hours prior to the start of the intervention. Phase 2: 72 hours after the final training session, to avoid the acute effects of exercise on the variables. Method of measurement: Using an ELISA kit. Islamic Azad University Approved 2024-04-27 Ethics Committee of Islamic Azad University, Ahvaz Branch Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)