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

NCT07099677 | Recruiting

• 1 other identifier: AIBU-FTR-AO-05
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Fall Risk; Postural Balance; Fear of Falling

Keywords

Antihypertensive drugs; Fall risk; Hypertension; Medication-related falls; Postural balance; Randomized controlled trial

Outcome Measures

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.

  Baseline (T0), Week 2 (T1), Week 4 (T2)

Secondary Outcomes (4)

• Postural Stability Indices (OSI, APSI, MLSI)

  Baseline (T0), Week 2 (T1), Week 4 (T2)

• Sensory Integration Scores (CTSIB)

  Baseline (T0), Week 2 (T1), Week 4 (T2)

• Falls Efficacy Scale (FES) Score

  Baseline (T0), Week 2 (T1), Week 4 (T2)

• Dizziness Handicap Inventory (DHI) - Total and Subscale Scores

  Baseline (T0), Week 2 (T1), Week 4 (T2)

Other Outcomes (3)

• Presence of Orthostatic Hypotension

  Baseline (T0)

• Presence of Dizziness

  Baseline (T0)

• Demographics (Age, BMI, Gender)

  Baseline (T0)

Study Arms (3)

Beta Blocker Group

EXPERIMENTAL

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

Drug: Beta Blocker

ACE Inhibitor Group

EXPERIMENTAL

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

Drug: ACE inhibitor

Calcium Channel Blocker Group

EXPERIMENTAL

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

Drug: Calcium channel blocker

Interventions

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.

Also known as: Angiotensin-converting enzyme blocker, ACEI, Standard ACE inhibitor therapy

ACE Inhibitor Group

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.

Also known as: Calcium Antagonist, CCB, Standard CCB therapy

Calcium Channel Blocker Group

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).

Also known as: Beta-Adrenergic Receptor Blocker, β-blocker, Beta-adrenergic antagonist

Beta Blocker Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

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

Bolu, 14030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Protease Inhibitors; Enzyme Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses

Study Officials

• Alp Ozel, PT, PhD

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alp Ozel, PT, PhD

CONTACT

+903742534520; alpozel@ibu.edu.tr

Umut A Ugras, MD

CONTACT

+905066434435; umutataugras@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the participants and the outcomes assessors will be masked to group allocation. Participants will not be informed about the specific antihypertensive drug they receive, and the individuals conducting the balance and symptom assessments will remain blinded to the treatment groups to reduce assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants diagnosed with primary hypertension will be randomly assigned to one of three parallel treatment groups using block randomization: beta-blocker (e.g., Metoprolol), ACE inhibitor (e.g., Ramipril), or calcium channel blocker (e.g., Amlodipine). Each group will receive its assigned intervention independently and concurrently, and outcome measures will be assessed at baseline, week 2, and week 4.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available starting after the main results are published in a peer-reviewed journal and will remain accessible indefinitely via the Zenodo repository (https://zenodo.org). A permanent DOI will be provided upon upload.
• Access Criteria: Anyone may access the de-identified data without restriction via the digital object identifier (DOI) assigned at the time of publication.

Locations

TU (1)