The Investigation of the Effectiveness of Virtual Reality Applications in Postmenopausal Osteoporosis Patients

Official title

The Investigation of the Effectiveness of Virtual Reality Applications in Postmenopausal Osteoporosis Patients: A Randomized Controlled Trial

Overview

Osteoporosis is a progressive disease characterised by a decrease in bone mass, deterioration in bone microarchitecture, and increased fragility. Etiologically, it is divided into two types: primary (postmenopausal and senile) and secondary. Postmenopausal women are particularly at high risk; it is seen in more than 80% of women over the age of 50 and in almost all individuals over the age of 75. With menopause, bone mineral density decreases, which negatively affects neuromuscular functions, leading to balance disorders, decreased walking speed, and an increased risk of falls. Falls are the primary cause of osteoporotic fractures and result in functional loss, morbidity, mortality, and increased healthcare costs. Exercise is effective in reducing bone loss; in recent years, therapeutic virtual reality and exercise games (exergames) have come to the fore. However, the literature on the effectiveness of these applications in postmenopausal osteoporosis patients is limited. The aim of this study is to investigate the effects of virtual reality applications on balance, quality of life, and fall risk and to compare them with a control group.

Detailed description

According to the World Health Organisation's definition, osteoporosis is characterised as a progressive disease involving a decrease in bone mass, deterioration in bone microarchitecture, and an increase in bone fragility. Osteoporosis is classified into two types based on aetiological factors: primary and secondary. Primary osteoporosis is subdivided into postmenopausal and senile osteoporosis, while the aetiology of secondary osteoporosis is unclear. Although osteoporosis can affect people of all ages, postmenopausal women are a particularly high-risk group for developing osteoporosis. Osteoporosis is seen in more than 80% of women over the age of 50 and in almost all women and men over the age of 75. Postmenopausal osteoporosis is the most common form of the disease. With the onset of menopause, a progressive decrease in bone mineral density is observed. This decrease in bone mineral density negatively affects the neuromuscular system. Neuromuscular dysfunction in patients with postmenopausal osteoporosis leads to a decrease in the ability to stand, impaired dynamic balance, and an increased risk of falling due to a decrease in walking speed. Falls are a significant risk factor in the development of osteoporotic fractures. The occurrence of osteoporosis-related fractures can lead to a decrease in functional capacity, an increase in morbidity and mortality rates, and higher healthcare costs. Exercise has a positive effect on reducing bone mineral density loss. However, advances in technology have also increased the availability of video games for therapeutic purposes. Virtual reality or exergame applications that incorporate video games have become a new trend in response to the global challenges of ageing. However, there is limited literature investigating the effectiveness of virtual reality applications in postmenopausal osteoporosis patients. The aim of this study is to investigate the effectiveness of virtual reality applications on balance, quality of life, and fall risk in postmenopausal osteoporosis patients and to compare them with a control group.

Interventions

• Other Conventional treatment
  Traditional treatment will consist of posture exercises aimed at ensuring proper posture, strengthening exercises, balance exercises, patient education aimed at preventing falls and fractures, aerobic exercises, and interventions aimed at controlling acute and chronic pain and restoring independence in daily living activities.
• Other Virtual reality treatment
  Virtual reality applications will consist of videos and video-based games (exergames). Should an application pose a risk to patients, the programme will be reviewed.

Primary outcome measures

• Balance Level [Time frame: 6 week]
• Cognitive State [Time frame: 6 week]
• Risk of Falling [Time frame: 6 week]

Secondary outcome measures (1)

• Quality of life in patients [Time frame: 6 week]

Eligibility criteria

Inclusion criteria

• Postmenopausal women aged 50-75 years
• Individuals diagnosed with osteoporosis based on Dual-Energy X-ray Absorptiometry (DEXA) measurement (T-score ≤ -2.5)
• Having been in menopause for at least 1 year
• Being able to walk independently (without the use of assistive devices)
• Volunteering to participate in the study and having provided informed consent
• Having adequate cognitive function (e.g., Mini Mental Test ≥ 24)

Exclusion criteria

• Secondary osteoporosis diagnosis (e.g. endocrine, metabolic or drug-induced causes)
• History of lower limb fracture or surgical intervention within the last 6 months
• Individuals with severe cardiovascular, neurological, or musculoskeletal disorders
• Individuals with vestibular or visual impairments that may affect balance
• Intolerance to virtual reality applications (e.g., dizziness, nausea, etc.)
• Individuals who have participated in a regular physiotherapy or exercise programme within the last 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Kırşehir Ahi Evran University — Center

Identifiers

NCT: NCT07231822 · 23591230588?

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗