Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
This study aims to provide clinical insight into how commonly used blood pressure medications may impact balance and fall risk in real-world settings.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta Blocker Group | Experimental | Participants will receive a beta blocker (e.g., Metoprolol) for antihypertensive treatment. |
|
| ACE Inhibitor Group | Experimental | Participants will receive an ACE inhibitor (e.g., Ramipril) for antihypertensive treatment. |
|
| Calcium Channel Blocker Group | Experimental | Participants will receive a calcium channel blocker (e.g., Amlodipine) for antihypertensive treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postural Stability Indices (OSI, APSI, MLSI) | Stability scores reflecting anterior-posterior and medial-lateral sway during standing, measured by the Biodex Balance System. | Baseline (T0), Week 2 (T1), Week 4 (T2) |
| Sensory Integration Scores (CTSIB) |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Orthostatic Hypotension | Dichotomous variable assessed at baseline (T0). Binary (Yes/No) | Baseline (T0) |
| Presence of Dizziness | Dichotomous variable assessed at baseline (T0). Binary (Yes/No). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alp Ozel, PT, PhD | Contact | +903742534520 | 6155 | alpozel@ibu.edu.tr |
| Umut A Ugras, MD | Contact | +905066434435 | umutataugras@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alp Ozel, PT, PhD | Abant Izzet Baysal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital | Recruiting | Bolu | 14030 | Turkey (Türkiye) |
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.
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.
Anyone may access the de-identified data without restriction via the digital object identifier (DOI) assigned at the time of publication.
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000319 | Adrenergic beta-Antagonists |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D002121 | Calcium Channel Blockers |
| ID | Term |
|---|---|
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
|
| 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. |
|
|
Composite scores from the Clinical Test of Sensory Interaction on Balance, measuring sensory contributions to balance.
| 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. | 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. | Baseline (T0), Week 2 (T1), Week 4 (T2) |
| Baseline (T0) |
| Demographics (Age, BMI, Gender) | Baseline covariates used for subgroup and interaction analyses. | Baseline (T0) |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D049990 | Membrane Transport Modulators |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |