EFFECTIVENESS AND CLINICAL OPTIMIZATION OF A STANDARDIZED PHYSIOTHERAPY EXERCISE PROGRAM TARGETING BALANCE-POSTURE INTERACTION AND FALL RISK IN OSTEOPOROSIS: A RANDOMIZED CONTROLLED TRIAL

Sponsor
Alma Mater Europaea - Slovenia
Study ID
NCT07763717
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Structured Physiotherapy Exercise Program — BEHAVIORAL
    12-week progressive multicomponent exercise program focusing on balance, posture correction, and strength training for osteoporosis patients.

Study Details

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).

Key Dates

First listed
Aug 13, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Mar 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: Standard Care
    Standard care including education on osteoporosis and general exercises.

Primary Outcome Measure

Change in Berg Balance Scale [ Time Frame: Baseline to 12 weeks post-intervention ]

Central Contacts

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