Short-Term Effects of Antihypertensive Drugs on Postural Balance and Fall Risk

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbant Izzet Baysal University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Beta Blocker

    Drug

    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).

  • ACE inhibitor

    Drug

    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.

  • Calcium channel blocker

    Drug

    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.

Treatment groups

186 Participants
are divided into 3 treatment groups
Group A: Beta Blocker GroupExperimental treatment 1 intervention
Group B: ACE Inhibitor GroupExperimental treatment 1 intervention
Group C: Calcium Channel Blocker GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

Presence of Orthostatic Hypotension

Dichotomous variable assessed at baseline (T0). Binary (Yes/No)

Time frame
Baseline (T0)
2

Presence of Dizziness

Dichotomous variable assessed at baseline (T0). Binary (Yes/No).

Time frame
Baseline (T0)
3

Demographics (Age, BMI, Gender)

Baseline covariates used for subgroup and interaction analyses.

Time frame
Baseline (T0)

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