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

Abant Izzet Baysal University

Status: Enrolling

Conditions: Hypertension; Postural Balance; Fall Risk; Fear of Falling

Treatments: Drug: ACE inhibitor; Drug: Beta Blocker; Drug: Calcium channel blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT07099677

AIBU-FTR-AO-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 3 patient groups

Beta Blocker Group

Experimental group

Description:

Participants will receive a beta blocker (e.g., Metoprolol) for antihypertensive treatment.

Treatment:

Drug: Beta Blocker

ACE Inhibitor Group

Experimental group

Description:

Participants will receive an ACE inhibitor (e.g., Ramipril) for antihypertensive treatment.

Treatment:

Drug: ACE inhibitor

Calcium Channel Blocker Group

Experimental group

Description:

Participants will receive a calcium channel blocker (e.g., Amlodipine) for antihypertensive treatment.

Treatment:

Drug: Calcium channel blocker