An interventional study of Structured Physiotherapy Exercise Program in Osteoporosis, Risk of Falls and Rehabilitation, sponsored by Alma Mater Europaea - Slovenia. Not yet recruiting at 1 site in Kosovo. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Alma Mater Europaea - Slovenia · Not applicable, Interventional, and Treatment
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).
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.
Few studies have assessed the significance of a change in an outcome measure in relation to the clinical meaning threshold of a minimal clinically important difference (MCID) to determine whether the change represents a clinically meaningful improvement in functional ability. Without this information, it is possible that a statistically significant outcome may not have any real-world value.
Although there is a high level of evidence regarding the efficacy of exercise in improving balance and fall risk among individuals with osteoporosis, a paucity exists in the following areas: (1) the standardisation and reproducibility of physiotherapy protocols, (2) physiotherapy interventions that target the interaction of balance and posture, (3) the optimal dose-response relationship of exercise, (4) objective biomechanical outcomes, and (5) clinical meaningfulness and implementation of physiotherapy programs. A rigorously developed randomised controlled trial to address these gaps would provide clinically useful information and have a substantial impact on physiotherapy treatment for osteoporosis.
Reduced BMD due to weakening bone matrix or skeleton leads to increased risk of fracture from weakness of normal bone matrix. Many cases of osteoporosis will also experience postural changes and symptoms like kyphosis, which can lead to problems with balance and fall risk are significant causes of reduced quality of life and decreased functional independence (Compston et al., 2019; Sözen et al., 2017). In fact, a recent WHO meta-analysis that utilized multiple systematic reviews focusing exclusively on individuals ages 65 and older demonstrated that regular engagement in physical activity may increase motor performance and decrease the risk for osteoporotic fractures (Pinheiro et al., 2020). According to a meta-analysis conducted by Hoffmann et al. (2023) with respect to the long-term use of structured exercise intervention, structured exercise interventions significantly reduce the likelihood of developing major osteoporotic fractures. In conclusion, while physical activity is widely recognized to provide substantial protective effects against osteoporosis, the exact type(s) and intensity of exercise to correctly address postural alignment and balance control for individuals with osteoporosis remains an area needing further study.
Physiotherapy provides non-pharmacological management of osteoporosis to alleviate pain, treat postural deformities, enhance balance, and decrease fall risk via the use of exercise-based therapeutic treatments (Giangregorio \& Papaioannou, 2014). It has been recommended by various professional organizations that a comprehensive exercise program should consist of muscle strengthening, balance, flexibility, and aerobic activity. An extensive international collaboration based upon multiple meta-analyses conducted on more than 30 randomized control trials has concluded that there are numerous benefits associated with increased exercise and participation in a structured exercise intervention program for patients with osteopenic or osteoporotic conditions (Bae et al 2023), which necessitates the development of a standardised physiotherapy intervention. Despite these recommendations, the delivery of physiotherapy remains inconsistent primarily because there is no consensus on which exercises to include, the order and frequency of these exercises, and how to monitor patient progress throughout the length of the program. Therefore, inconsistencies in the delivery of exercise intervention programs result in inconsistent treatment outcomes and impediments in the transfer of current scientific evidence into clinically applicable, standardized physiotherapy protocols.
Clinical research shows that an exercise regimen that combines structured and unstructured activities is effective in improving functional capacity, posture and balance for those suffering from osteoporosis. Papalia et al. (2020) completed a meta-analysis of previously published studies involving individuals aged 65 years or older. The overall findings from this study were that combined exercise programs improved balance and decreased the number of falls among older adults. Wei et al. (2023) conducted a review of ten randomized controlled trials and found that balance training improves both static and dynamic balance, while at the same time decreases fears associated with falling for individuals with osteoporosis. In addition, Shojaa et al. (2020) reported that the incorporation of resistance and impact-based exercise programs are effective in increasing the bone mineral density for post-menopausal women. Papaioannou et al. (2020) found that postural kyphosis and muscle weakness were two of the main risk factors associated with falling. Sinaki (2018) further confirmed that strengthening of the para-spinal muscles is important for postural correction and fall prevention. In support of these findings, Carter et al. (2021) reported that individuals who are engaged in an integrated exercise program may have a 23%-40% reduction in their fall risk. While the majority of the available literature focus on isolated outcomes (balance or bone density), the evidence currently available on the overall impact of postural correction combined with balance control to reduce the risk of falling is currently very limited.
The idea of balance and posture interact with each other dynamically and in a reciprocal manner for both static activities and functional activities. Postural alignment determines how the segments of the body are arranged in 3D space and also determines where the centre of mass is located relative to a given base of support. The person uses the neuromuscular system to maintain or regain stability when there are internal and external forces acting upon the person. Impairments associated with osteoporosis, such as older age, thoracic kyphosis, weak trunk muscles, altered spinal alignment and decreased proprioception, can interfere with the balance-posture interaction and predispose the individual to compensatory movement strategies, decreased stability, and increased risk of falling. It is proposed therefore, that balance and posture not be treated as independent entities but rather that they are interdependent components of a person's ability to move functionally or prevent falls.
The present study will document/operationalize how the interaction of balance and posture will be measured with the simultaneous assessment of both postural alignment and balance performance. The evaluation of postural alignment will consist of the use of established clinical measures of spinal posture and balance performance will consist of validating the results of standardised static and dynamic tests of balance. The extent of interaction among these parameters will be measured by assessing how much improvement in one parameter is accompanied by improvement in another parameter or multiple balance and fall risk indicators. This approach will allow investigators to determine whether or not correcting posture alone or with balance training aids in the enhancement of balance control and therefore in the enhancement of functional stability.
By using correlational and multivariate statistical methods to analyse data on participant postural variables, balance- and balance-related variables, during the course of the study, investigators will be able to assess the extent of the relationships among these variables and how these relationships may change after participant intervention. The results of participant assessment following the intervention will provide investigators with a biomechanical framework for the interpretation of these data. Specifically, it is predicted that improved spinal alignment will position the centre of mass optimally, thus improving control strategies for posture and reducing instability during functional activities. A statistically significant improvement in both areas, along with a strong positive correlation between postural and balance measures, will further strengthen support for the theoretical framework that the integration of postural correction and balance training provides an effective clinical mechanism to reduce the risk of falling among individuals with osteoporosis.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 88 is close to the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Alma Mater Europaea - Slovenia is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: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.
Exclusion Criteria:
o Presence of any neurological disorder (e.g., Parkinson's disease, stroke) that significantly affects balance or mobility.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Structured Physiotherapy Exercise Program
Standard care including education on osteoporosis and general exercises.
Behavioral: Structured Physiotherapy Exercise Program
12-week progressive multicomponent exercise program focusing on balance, posture correction, and strength training for osteoporosis patients.
Change in Berg Balance Scale
Improvement in postural balance assessed by Berg Balance Scale (BBS) scores
Time frame: Baseline to 12 weeks post-intervention
Change in thoracic kyphosis (inclinometer)
Reduction in thoracic kyphosis and improvement in posture measured by clinical inclinometer.
Time frame: Baseline to 12 weeks post-intervention.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
Of 219 non-industry interventional studies with no phase under Osteoporosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 49. This study's planned 6 months is below that.
Counting every sponsor, half of 238 studies reached it within 26 months; a quarter within 9 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alma Mater Europaea - Slovenia