]>
IRCT20260125068657N1 IRCT 2026-02-27 Razi University The Effect of 12-Week Aerobic Training Combined with a Low-Sodium Diet on Blood Pressure and Pulmonary Function in Obese Elderly Adults with Hypertension The Effect of 12 week of Aerobic Exercise Combined with a Low-Sodium Diet on Blood Pressure and Pulmonary Function in Obese Elderly Individuals with Hypertension 2026-03-11 anticipated 48 Complete https://irct.ir/trial/88943 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible participants, after completing the baseline assessment, will be randomly assigned to either the "intervention" or "control" group. The randomization process will be performed using a **block randomization** method with blocks of four, and will be stratified based on **treatment center** and **disease severity** (stratified randomization). The unit of randomization in this study is the individual. The random allocation sequence will be generated by an individual not involved in the trial's execution, using SAS statistical software (version 9.4). To ensure allocation concealment, the group assignment for each participant will be placed inside sequentially numbered, opaque, sealed envelopes. These envelopes will only be opened by the researcher after a participant's final eligibility is confirmed and at the moment of enrollment in the study. The detailed procedure for randomization is as follows: first, the list of eligible participants will be categorized based on the strata (center and disease severity). Then, for each stratum separately, blocks of four with a specific random sequence (maintaining a 1:1 ratio for intervention and control groups) will be generated by the software. These assignments will be placed in the numbered envelopes and distributed to the centers. Using this method, both the researcher and the participant remain unaware of the next group assignment until after the allocation is finalized, thereby minimizing selection bias, Blinding description: This study will employ a single-blind design. The participants will be blinded to their group allocation (intervention or control). Exercise trainers and clinical assessors will not be blinded to the intervention type, but all efforts will be made to standardize interactions with both groups. N/A Hypertension. Intervention 1: Intervention group: Combined Group; Receives aerobic exercise (3 sessions/week, 12 weeks) combined with a low-sodium diet (<2g sodium/day). Intervention 2: Intervention group: Exercise Group; Receives only the aerobic exercise program. Intervention 3: Intervention group: Diet Group; Receives only the low-sodium diet. Intervention 4: Control group: Receives usual care without the specific exercise or dietary intervention of this study. Yes - There is a plan to make this available What will be shared: All data will be recorded in the SPSS software and will be available When: Availability will start nine months after publishing all papers To whom: Only available for researchers in academic and scientific institutions Conditions: All data can be used as a reference Where to obtain: sahelveiskarami93@gmail.com How to obtain: If the explanation for the data request would be convincing it will be given in 3 days. Comments:
public Rastegar Hoseini
No. 9, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah City
Kermanshah Iran (Islamic Republic of) 6714967346 +98 83 3428 3270 R.hoseini@razi.ac.ir Razi University scientific Sahel Viskaremi
No. 9, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah City
Kermanshah Iran (Islamic Republic of) 6714967346 +98 83 3428 3270 sahelveiskarami93@gmail.com Razi Univeristy Iran (Islamic Republic of) Age ≥ 60 years, and provision of informed consent. Obesity (BMI ≥ 30 kg/m²) stage 1 or 2 hypertension on stable pharmacological treatment Medical clearance for moderate-intensity exercise Absence of acute cardio-pulmonary diseases No regular participation in structured exercise programs or a low-sodium diet in the past 6 months 60 years 75 years Female Serious or uncontrolled comorbidities (e.g., cardiovascular, pulmonary, renal, or diabetes). Use of medications affecting blood pressure or body weight (other than stable antihypertensive therapy) Having severe orthopedic limitations Active smoking within the past year I27.2 Other secondary pulmonary hypertension Prevention Prevention Prevention Placebo Intervention group: Combined Group; Receives aerobic exercise (3 sessions/week, 12 weeks) combined with a low-sodium diet (<2g sodium/day) Intervention group: Exercise Group; Receives only the aerobic exercise program. Intervention group: Diet Group; Receives only the low-sodium diet. Control group: Receives usual care without the specific exercise or dietary intervention of this study. Systolic and Diastolic Blood Pressure. Timepoint: Study baseline, Week 6, and post-intervention at Week 12. Method of measurement: Measured using a calibrated digital sphygmomanometer after 5 minutes of seated rest. Forced Expiratory Volume in 1 second (FEV1). Timepoint: Study baseline and post-intervention at Week 12. Method of measurement: Measured using a spirometer according to standard ATS/ERS guidelines. Forced Vital Capacity (FVC). Timepoint: Study baseline and post-intervention at Week 12. Method of measurement: Measured using a spirometer according to standard ATS/ERS guidelines. FEV1/FVC Ratio. Timepoint: Study baseline and post-intervention at Week 12. Method of measurement: Measured using a spirometer according to standard ATS/ERS guidelines. Razi University Approved 2025-12-29 Research Ethics Committees of Kermanshah Razi University No. 8, Razi University, Daneshgah Boulevard, Taq Bostan Street, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)