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NCT Number: NCT07099677

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital

Bolu, 14030, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Able to walk independently without assistive devices
  • Provided written informed consent to participate in the study

Exclusion criteria

  • 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
  • Cognitive impairment preventing proper test participation
  • Inability to complete the assessments at follow-up timepoints (2nd and 4th week)

Treatment and study plan

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).

Other names: Beta-Adrenergic Receptor Blocker, β-blocker, Beta-adrenergic antagonist

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.

Other names: Angiotensin-converting enzyme blocker, ACEI, Standard ACE inhibitor therapy

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.

Other names: Calcium Antagonist, CCB, Standard CCB therapy

Primary outcomes

  1. Fall Risk Score (Biodex Balance System)

    Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)

    Objective assessment of fall risk using the Fall Risk Test on the Biodex Balance System. Higher scores indicate greater fall risk.

Secondary outcomes

  1. Postural Stability Indices (OSI, APSI, MLSI)

    Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)

    Stability scores reflecting anterior-posterior and medial-lateral sway during standing, measured by the Biodex Balance System.

  2. Sensory Integration Scores (CTSIB)

    Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)

    Composite scores from the Clinical Test of Sensory Interaction on Balance, measuring sensory contributions to balance.

  3. Falls Efficacy Scale (FES) Score

    Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)

    Self-reported fear of falling during daily activities, total score ranges from 10 to 40.

  4. Dizziness Handicap Inventory (DHI) - Total and Subscale Scores

    Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)

    Measures physical, emotional, and functional impact of dizziness. Total score range: 0-100.

Other outcomes

  1. Presence of Orthostatic Hypotension

    Time frame: Baseline (T0)

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

  2. Presence of Dizziness

    Time frame: Baseline (T0)

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

  3. Demographics (Age, BMI, Gender)

    Time frame: Baseline (T0)

    Baseline covariates used for subgroup and interaction analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

Alp Ozel, PT, PhD

CONTACT

[email protected]

+903742534520 ext. 6155

Umut A Ugras, MD

CONTACT

[email protected]

+905066434435

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Effect of Antihypertensive Medication Use on Fall Risk: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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