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
To investigate the effect of a 12-week combined aerobic exercise and low-sodium diet program on blood pressure levels and pulmonary function in obese elderly individuals with hypertension
Design
This research is a parallel-group, randomized controlled trial where participants are randomly allocated into four groups (combined, exercise, diet, control). The study design is single-blind.
Settings and conduct
Sampling Method: Convenience Sampling will be employed.
Study Setting: The study will be conducted at the Mehr-e Nikān Elderly Center and the Specialized Clinic of Samen al-A'emmeh (AS) in Kermanshah, Iran.
Participants/Inclusion and exclusion criteria
Inclusion: Elderly (≥60 years) with obesity (BMI≥30) and mild‑moderate hypertension on stable treatment, medically cleared for exercise, and no recent regular exercise/special diet.
Exclusion: Significant acute/uncontrolled comorbidities, use of medications affecting metabolism/weight, severe physical limitations, or confounding behavioral factors (smoking/alcohol use).
Intervention groups
Combined Group: Aerobic exercise + Low-sodium diet.
Exercise Group: Aerobic exercise only.
Diet Group: Low-sodium diet only.
Control Group: Usual care (no exercise or dietary intervention of the study).
Main outcome variables
Blood Pressure (measured with a digital sphygmomanometer)
Pulmonary Function including:
Forced Expiratory Volume in 1 second (FEV1)
Forced Vital Capacity (FVC)
FEV1/FVC Ratio
(measured by spirometry)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260125068657N1
Registration date:2026-02-27, 1404/12/08
Registration timing:prospective
Last update:2026-02-27, 1404/12/08
Update count:0
Registration date
2026-02-27, 1404/12/08
Registrant information
Name
Sahel Veiskarami
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 1980
Email address
sahelveiskarami93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-11, 1404/12/20
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kermanshah Razi University