The Effect of Antihypertensive Medication Use on Fall Risk: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Fall Risk Score (Biodex Balance System)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Calcium Channel Blocker Group
Participants will receive a calcium channel blocker (e.g., Amlodipine) for antihypertensive treatment.
干预措施: Calcium channel blocker (Drug)
Beta Blocker Group
Participants will receive a beta blocker (e.g., Metoprolol) for antihypertensive treatment.
干预措施: Beta Blocker (Drug)
ACE Inhibitor Group
Participants will receive an ACE inhibitor (e.g., Ramipril) for antihypertensive treatment.
干预措施: ACE inhibitor (Drug)
结局指标
主要结局
Fall Risk Score (Biodex Balance System)
时间窗: 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.
次要结局
- 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))
研究者
Alp Ozel
Assistant Professor
Abant Izzet Baysal University