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

NCT07763717 | Not Yet Recruiting DMC

• 1 other identifier: 610 PKE/42
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Osteoporosis; Risk of Falls; Rehabilitation

Keywords

Physiotherapy, osteoporosis, balance, posture, risk of falls, exercise program, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Berg Balance Scale

  Improvement in postural balance assessed by Berg Balance Scale (BBS) scores

  Baseline to 12 weeks post-intervention

Secondary Outcomes (1)

• Change in thoracic kyphosis (inclinometer)

  Baseline to 12 weeks post-intervention.

Study Arms (2)

Experimental Arm: Structured Physiotherapy Exercise Program

EXPERIMENTAL

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

ACTIVE COMPARATOR

Standard care including education on osteoporosis and general exercises.

Behavioral: Structured Physiotherapy Exercise Program

Interventions

Structured Physiotherapy Exercise Program BEHAVIORAL

12-week progressive multicomponent exercise program focusing on balance, posture correction, and strength training for osteoporosis patients.

Experimental Arm: Structured Physiotherapy Exercise Program; Standard Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alma Mater Europaea - Slovenia: lead

Study Sites (1)

University Clinical Center of Kosovo

Pristina, 10050, Kosovo

Location

Related Publications (1)

• Bae S, Lee S, Park H, Ju Y, Min SK, Cho J, Kim H, Ha YC, Rhee Y, Kim YP, Kim C. Position Statement: Exercise Guidelines for Osteoporosis Management and Fall Prevention in Osteoporosis Patients. J Bone Metab. 2023 May;30(2):149-165. doi: 10.11005/jbm.2023.30.2.149. Epub 2023 May 31.

  PMID: 37449348 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Bajram Shyti, PhD (C)

CONTACT

+38344599505; bajramed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)