Effectiveness and Clinical Optimization of a Standardized Physiotherapy Exercise Program Targeting Balance-Posture Interaction and Fall Risk in Osteoporosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in Berg Balance Scale
研究概览
简要总结
Osteoporosis is a systemic disorder of the skeletal system characterized by decreased Bone Mass and deterioration of the Microarchitecture, making it significantly easier to fracture the bones. In addition to the increased risk of fracture due to reduced Bone Strength, other common impairments in the balance, postural control and coordination of muscles may increase the risk of falling, as well. Recent research has increasingly begun to conceptually link fall risk to be a multi-factorial issue, due to the interaction of the biomechanical, neuromuscular and functional deficits that an older person most likely experiences in conjunction with the effects of ageing (Papalia et al., 2020). As such, physiotherapy techniques for treating persons at risk of falling have progressed away from providing isolated (and consequently limited) gains in strength or mobility, towards providing a more multi-faceted and thus comprehensive, integrated method of enhancing overall physical performance through exercise.
Physical activity interventions are being used to treat the condition of osteoporosis and have been identified as an essential component of preventing osteoporosis. Many recent statements have indicated that through the incorporation of organized physical activity into each individual's physical activity routine, as opposed to the previous recommendation for just resistance training and balance activities, the ability for individuals to experience a change in their physical abilities and thereby decrease their risk of falling is significantly improved (Brooke-Wavell et al., 2022; Bae et al., 2023). Among the many types of exercise-based interventions for treating osteoporosis, those that focus on improving balance have been shown to be effective in improving stability of the body postural position as well as decreasing the fear of falling (which can contribute to decreased mobility and increase the risk of falling) (Wei et al., 2023). A systematic review and analysis of the available literature indicates that targeted balance training is effective for improving both static and dynamic postural stability among older adults and persons with osteoporosis; moderate effects were found with regard to the risk of falling as a result of balance training (Zhou et al., 2018; Papalia et al., 2020).
Randomized controlled trials provide additional evidence of the positive impact of physiotherapy programs on their clinical use. For Osteoporotic women, having balance training interventions leads to the to the outcome of significantly reducing falls and enhancing stability (Mikó et al., 2017). On the same note, Multicomponent programs that combine resistance and balance training have resulted in increased muscle strength, physical performance and health-related quality of life for patients with vertebral fractures, along with reduced fear of falling. (Stanghelle et al., 2020). Newer developments in this area such as virtual reality exercise programs have provided additional improvements in Balance performance and increased patient engagement in rehabilitation (Yilmaz & Kösehasanoğulları, 2024).
详细描述
Many intervention studies focus on short-term outcomes, but there are Few studies that examine the Long-term effects of the interventions themselves. Also Fall risk is typically assessed using indirect measures (i.e., Balance tests, or self-reported fear of falling), while Pri few studies use objective measures of fall occurrence or comprehensive biomechanics. Finally, There are few Randomized Controlled Trials with Rigorous Design that Evaluate Standardized Physiotherapy protocols aimed at enhancing the integration of Postural alignment and Dynamic Balance control in Osteoporotic individuals.
The current literature on exercise has a major limitation in that a large degree of variation exists between the exercise protocols. For example, the exercise protocols vary greatly in terms of frequency, intensity, duration, progression criteria, and level of supervision. This large degree of heterogeneity limits the ability to reproduce the results and ultimately eliminates the opportunity to fully determine the optimal intervention parameters. Few studies have had a structured approach to examining the dose-response relationship between exercise and the associated clinical outcomes, which provides little guidance to clinicians regarding what the minimum and/or optimal dosage of exercise should be for clinically meaningful outcomes.
Most of the interventions regard balance as a separate domain from posture, rather than taking into account the dynamic interaction of balance and posture. The postural alignment directly affects the center of mass and biomechanical stability and will subsequently affect the balance strategies and risk of falling. However, to date, physiotherapy models have not integrated the balance-posture interaction. There is a significant void in the current literature regarding physiotherapy models for balancing and posturing.
A major gap exists in the implementation of physiotherapy protocols, with numerous shortcomings associated with multicomponent programs that are recommended; for example, interventions are often poorly defined, lacking the level of detail necessary for the exercise selection process, progression algorithms, and strategies for individualisation. This limitation has restricted the global scalability and clinical translation of exercise interventions and created barriers to implementation in real-world rehabilitation.
Outcome assessment in current studies has primarily employed clinical scales (balance tests, fear of falling questionnaires) and does not incorporate sufficient objective biomechanical outcome measures that can objectively quantify performance, such as centre of pressure displacement, postural sway, and movement kinematics. The absence of objective biomechanical outcomes limits the understanding of the underlying mechanical principles and restricts the ability to determine the efficacy of the interventions.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Confirmed clinical diagnosis of osteoporosis, established through standard diagnostic procedures such as bone mineral density (BMD) assessment (e.g., T-score ≤ -2.5 at the lumbar spine, femoral neck, or total hip) or a physician's diagnosis based on clinical history and fracture risk assessment.
- •Aged 50 years or older.
- •Ability to understand and follow verbal and written instructions in Albanian.
- •Ability to ambulate independently, with or without an assistive device, for at least 10 meters.
- •Willingness to provide informed consent and commit to the full 12-week intervention period and follow-up assessments.
排除标准
- •o Presence of any neurological disorder (e.g., Parkinson's disease, stroke) that significantly affects balance or mobility.
- •Acute fractures or recent (within the last 6 months) osteoporotic fractures that would preclude participation in an exercise program.
- •Severe cardiovascular or respiratory conditions that would contraindicate moderate-intensity exercise.
- •Uncontrolled systemic diseases (diabetes, hypertension).
- •Cognitive impairment that would interfere with understanding or adhering to the study protocol.
- •Participation in another balance or strength training program within the last 3 months.
- •Any other medical condition or medication use that, in the opinion of the primary investigator, would compromise participant safety or the integrity of the study results.
研究组 & 干预措施
Experimental Arm: Structured Physiotherapy Exercise Program
Structured 12-week physiotherapy exercise program targeting balance-posture interaction and fall risk in osteoporosis patients. Includes progressive multicomponent exercises (balance, posture correction, strength), with defined frequency, duration, progression criteria, and supervision.
干预措施: Structured Physiotherapy Exercise Program (Behavioral)
Standard Care
Standard care including education on osteoporosis and general exercises.
干预措施: Structured Physiotherapy Exercise Program (Behavioral)
结局指标
主要结局
Change in Berg Balance Scale
时间窗: Baseline to 12 weeks post-intervention
Improvement in postural balance assessed by Berg Balance Scale (BBS) scores
次要结局
- Change in thoracic kyphosis (inclinometer)(Baseline to 12 weeks post-intervention.)
研究者
Tine Kovačič
Assistant Professor
Alma Mater Europaea - Slovenia