An interventional study of Beta Blocker and ACE inhibitor in Hypertension, Fall Risk and Postural Balance, sponsored by Abant Izzet Baysal University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare the short-term effects of three commonly prescribed antihypertensive drug classes (beta-blockers, ACE inhibitors, and calcium channel blockers) on postural balance and fall risk in adults with newly diagnosed primary hypertension. The main questions it aims to answer are:
Researchers will use a balance analysis system (Biodex Balance System) and self-reported scales (Dizziness Handicap Inventory and Falls Efficacy Scale) to assess outcomes. Participants will:
This study aims to provide clinical insight into how commonly used blood pressure medications may impact balance and fall risk in real-world settings.
Falls and balance impairments are significant health concerns, particularly in individuals with hypertension who may be starting pharmacological treatment. Some antihypertensive drugs are known to cause side effects such as dizziness, postural hypotension, and impaired balance, all of which can increase fall risk. Despite this, comparative evidence on the short-term impact of different antihypertensive drug classes on postural balance remains limited.
This randomized controlled trial aims to compare the effects of three first-line antihypertensive drug classes-beta-blockers (e.g., metoprolol), ACE inhibitors (e.g., ramipril), and calcium channel blockers (e.g., amlodipine)-on postural stability and fall risk during the initial four weeks of treatment. Participants will be individuals aged 18-75 years who have been newly diagnosed with primary hypertension and have not previously used antihypertensive medications.
Assessments will be conducted using both objective and subjective measures. Objective balance evaluations will be performed using the Biodex Balance System, including the Fall Risk Test, Postural Stability Test (overall, anterior-posterior, and medial-lateral stability indices), and the Clinical Test of Sensory Interaction on Balance (CTSIB). Subjective assessments will include the Falls Efficacy Scale (FES) to evaluate fear of falling and the Dizziness Handicap Inventory (DHI) to assess the impact of dizziness on daily life.
The trial will include three evaluation time points: baseline (before starting treatment), week 2, and week 4. By providing a multidimensional assessment of balance performance, the study seeks to identify potential safety concerns and guide clinicians in making informed treatment decisions based on both cardiovascular and postural health.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 186 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Participants will receive a beta blocker (e.g., Metoprolol) for antihypertensive treatment.
Drug: Beta Blocker
Participants will receive an ACE inhibitor (e.g., Ramipril) for antihypertensive treatment.
Drug: ACE inhibitor
Participants will receive a calcium channel blocker (e.g., Amlodipine) for antihypertensive treatment.
Drug: Calcium channel blocker
Participants in this group will receive standard antihypertensive treatment with a beta-adrenergic receptor blocker. The exact agent and dosage will be determined by the cardiology clinic according to clinical guidelines. Balance and fall risk assessments will be conducted at baseline (T0), week 2 (T1), and week 4 (T2).
Also known as: Beta-Adrenergic Receptor Blocker, β-blocker, Beta-adrenergic antagonist
Participants in this group will receive standard antihypertensive treatment with an angiotensin-converting enzyme inhibitor. The dose and specific agent will be prescribed based on routine clinical criteria. Assessments will take place at T0, T1, and T2.
Also known as: Angiotensin-converting enzyme blocker, ACEI, Standard ACE inhibitor therapy
This group will receive a calcium channel blocker as part of their standard hypertension management. Dosage and agent will follow standard cardiology practice. Postural balance and fall risk will be measured at all study time points.
Also known as: Calcium Antagonist, CCB, Standard CCB therapy
Fall Risk Score (Biodex Balance System)
Objective assessment of fall risk using the Fall Risk Test on the Biodex Balance System. Higher scores indicate greater fall risk.
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Postural Stability Indices (OSI, APSI, MLSI)
Stability scores reflecting anterior-posterior and medial-lateral sway during standing, measured by the Biodex Balance System.
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Sensory Integration Scores (CTSIB)
Composite scores from the Clinical Test of Sensory Interaction on Balance, measuring sensory contributions to balance.
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Falls Efficacy Scale (FES) Score
Self-reported fear of falling during daily activities, total score ranges from 10 to 40.
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Dizziness Handicap Inventory (DHI) - Total and Subscale Scores
Measures physical, emotional, and functional impact of dizziness. Total score range: 0-100.
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Presence of Orthostatic Hypotension
Dichotomous variable assessed at baseline (T0). Binary (Yes/No)
Time frame: Baseline (T0)
Presence of Dizziness
Dichotomous variable assessed at baseline (T0). Binary (Yes/No).
Time frame: Baseline (T0)
Demographics (Age, BMI, Gender)
Baseline covariates used for subgroup and interaction analyses.
Time frame: Baseline (T0)
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the publication-including demographic variables, group allocation, balance test scores (Fall Risk Score, OSI, APSI, MLSI, CTSIB), Falls Efficacy Scale (FES), Dizziness Handicap Inventory (DHI) scores, and related clinical data (e.g., presence of orthostatic hypotension, reported dizziness)-will be shared.
Supporting information: Study protocol, Sap, Icf, Analytic code
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Abant Izzet Baysal University