HypertensionNCT07099677
Short-Term Effects of Antihypertensive Drugs on Postural Balance and Fall Risk
A study testing Beta Blocker, ACE inhibitor and Calcium channel blocker in people with Hypertension and Fall Risk, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Fall Risk, Postural Balance
- What is being tested?
- Beta Blocker, ACE inhibitor and Calcium channel blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital
Bolu, 14030
About this study
Official title: The Effect of Antihypertensive Medication Use on Fall Risk: A Randomized Controlled 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?
Read more
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.
Read the detailed 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.
- Conditions
- Hypertension, Fall Risk, Postural Balance, Fear of Falling
- Being tested
- Beta Blocker, ACE inhibitor, Calcium channel blocker
- Keywords
- Antihypertensive drugs, Fall risk, Hypertension, Medication-related falls, Postural balance, Randomized controlled trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta BlockerDrug
Also called Beta-Adrenergic Receptor Blocker, β-blocker, Beta-adrenergic antagonist
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 inhibitorDrug
Also called Angiotensin-converting enzyme blocker, ACEI, Standard ACE inhibitor therapy
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 blockerDrug
Also called Calcium Antagonist, CCB, Standard CCB therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Beta Blocker Group | Experimental | Participants will receive a beta blocker (e.g., Metoprolol) for antihypertensive treatment. Receives: Drug: Beta Blocker |
| ACE Inhibitor Group | Experimental | Participants will receive an ACE inhibitor (e.g., Ramipril) for antihypertensive treatment. Receives: Drug: ACE inhibitor |
| Calcium Channel Blocker Group | Experimental | Participants will receive a calcium channel blocker (e.g., Amlodipine) for antihypertensive treatment. Receives: Drug: Calcium channel blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), Week 2 (T1), Week 4 (T2)
Secondary outcomes (4)
Postural Stability Indices (OSI, APSI, MLSI)
Stability scores reflecting anterior-posterior and medial-lateral sway during standing, measured by the Biodex Balance System.
Measured: Baseline (T0), Week 2 (T1), Week 4 (T2)
Sensory Integration Scores (CTSIB)
Composite scores from the Clinical Test of Sensory Interaction on Balance, measuring sensory contributions to balance.
Measured: Baseline (T0), Week 2 (T1), Week 4 (T2)
Falls Efficacy Scale (FES) Score
Self-reported fear of falling during daily activities, total score ranges from 10 to 40.
Measured: Baseline (T0), Week 2 (T1), Week 4 (T2)
Dizziness Handicap Inventory (DHI) - Total and Subscale Scores
Measures physical, emotional, and functional impact of dizziness. Total score range: 0-100.
Measured: Baseline (T0), Week 2 (T1), Week 4 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ozel, Abant Izzet Baysal University
- Investigators
- Alp Ozel, PT, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099677
- Sponsor's protocol ID
- AIBU-FTR-AO-05
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the publication-including demographic variables, group allocation, balance test scores (Fall Risk Score, OSI, APSI, MLSI, CTSIB), Falls Efficacy Scale (FES), Dizziness Handicap Inventory (DHI) scores, and related clinical data (e.g., presence of orthostatic hypotension, reported dizziness)-will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antihypertensive Medication Use on Fall Risk: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07099677
- Acronym / sponsor ID
- AIBU-FTR-AO-05
- Conditions
- Hypertension, Fall Risk, Postural Balance, Fear of Falling
- Keywords
- Antihypertensive drugs, Fall risk, Hypertension, Medication-related falls, Postural balance, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Beta Blocker Group | Experimental | Drug: Beta BlockerParticipants will receive a beta blocker (e.g., Metoprolol) for antihypertensive treatment. |
| ACE Inhibitor Group | Experimental | Drug: ACE inhibitorParticipants will receive an ACE inhibitor (e.g., Ramipril) for antihypertensive treatment. |
| Calcium Channel Blocker Group | Experimental | Drug: Calcium channel blockerParticipants will receive a calcium channel blocker (e.g., Amlodipine) for antihypertensive treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta BlockerAlso: Beta-Adrenergic Receptor Blocker, β-blocker, Beta-adrenergic antagonistParticipants 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). | Drug | Beta Blocker Group |
| ACE inhibitorAlso: Angiotensin-converting enzyme blocker, ACEI, Standard ACE inhibitor therapyParticipants 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. | Drug | ACE Inhibitor Group |
| Calcium channel blockerAlso: Calcium Antagonist, CCB, Standard CCB therapyThis 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. | Drug | Calcium Channel Blocker Group |
Primary outcome
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.
4 secondary outcomes
Postural Stability Indices (OSI, APSI, MLSI)
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Sensory Integration Scores (CTSIB)
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Falls Efficacy Scale (FES) Score
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Dizziness Handicap Inventory (DHI) - Total and Subscale Scores
Time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the publication-including demographic variables, group allocation, balance test scores (Fall Risk Score, OSI, APSI, MLSI, CTSIB), Falls Efficacy Scale (FES), Dizziness Handicap Inventory (DHI) scores, and related clinical data (e.g., presence of orthostatic hypotension, reported dizziness)-will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alp Ozel, PT, PhD principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta Blocker, ACE inhibitor and Calcium channel blocker in people with Hypertension and Fall Risk, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alp Ozel, PT, PhD (+903742534520 ext. 6155, alpozel@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Risk Score (Biodex Balance System) (time frame: Baseline (T0), Week 2 (T1), Week 4 (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.