About this trial
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:
* Do different antihypertensive drugs affect objective balance performance and fall risk? * What are the effects of these medications on dizziness and fear of falling?
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:
* Be randomly assigned to one of three drug groups (metoprolol, ramipril, or amlodipine) * Be evaluated at baseline (prior to treatment), at 2 weeks, and at 4 weeks after starting treatment * Complete balance tests and questionnaires at each time point
This study aims to provide clinical insight into how commonly used blood pressure medications may impact balance and fall risk in real-world settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 75 years
Newly diagnosed with primary hypertension
No prior use of antihypertensive medication
No history of neurological, vestibular, orthopedic, or psychiatric conditions affecting balance
Disqualifiers
Secondary hypertension
Known diagnosis of vestibular disorders (e.g., BPPV, Ménière's disease)
Use of medications that may affect balance (e.g., sedatives, psychotropic drugs)
History of falls due to trauma unrelated to balance
Trial design
Parallel
Treatments tested in this trial
Beta Blocker
DrugParticipants 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).
ACE inhibitor
DrugParticipants 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.
Calcium channel blocker
DrugThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Postural Stability Indices (OSI, APSI, MLSI)
Stability scores reflecting anterior-posterior and medial-lateral sway during standing, measured by the Biodex Balance System.
Sensory Integration Scores (CTSIB)
Composite scores from the Clinical Test of Sensory Interaction on Balance, measuring sensory contributions to balance.
Falls Efficacy Scale (FES) Score
Self-reported fear of falling during daily activities, total score ranges from 10 to 40.
Dizziness Handicap Inventory (DHI) - Total and Subscale Scores
Measures physical, emotional, and functional impact of dizziness. Total score range: 0-100.
Other outcomes
Presence of Orthostatic Hypotension
Dichotomous variable assessed at baseline (T0). Binary (Yes/No)
Presence of Dizziness
Dichotomous variable assessed at baseline (T0). Binary (Yes/No).
Demographics (Age, BMI, Gender)
Baseline covariates used for subgroup and interaction analyses.
Sponsors and contacts
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