Clinical trial NCT04862910: Effects of Kinect-based Virtual Reality Training in Postmenopausal Women With Osteopenia
Official title: Effects of Kinect-based Virtual Reality Training on Bone Mineral Density, Fracture Risk, Physical Performance and Quality of Life in Postmenopausal Women With Osteopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Osteopenia
Keywords: Postmenopausal Osteopenia
Bone Mineral Density
Virtual Reality
Fracture
Quality of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 52
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteopenia is a clinical term to define the declined Bone Mineral Density (BMD) as per the normal reference values but not low enough to meet osteoporotic diagnostic criteria. A Dual-energy x-ray absorptiometry (DXA) bone scan is used to diagnose decreased BMD. Osteopenia is, as described by the World Health Organization (WHO), a score ranging from -1 to -2.5, whereas Osteoporosis is diagnosed with values less than - 2.5. The risk of a decrease in BMD doubles as a woman goes into Menopause. The objective of this study will be to determine the effects of Kinect-based virtual reality training on BMD, fracture risk, physical function and Quality of life in postmenopausal women with Osteopenia.

This study will be a Randomized controlled trial. The study will be conducted at Riphah Rehabilitation Center, Lahore. Duration of the study will be 18 months. The sample size will be calculated after the completion of the pilot study. Initial screening of the participants will be done as per screening protocol and participants fulfilling inclusion criteria will be randomly allocated into two groups. Group A will receive Kinect based virtual reality training along with routine diet and routine Medication. Group B will be controlled with routine diet and routine Medication. Participants of both groups will be assessed at baseline for BMD, risk of fracture, all Objective and subjective parameters of Physical Performance and Quality of Life. Post-treatment assessment of Physical performance measures and Quality of life will be done after the 12th and 24th week, while BMD and fracture risk will be measured only after the 24th week. BMD will be measured by Dual-Energy X-ray Absorptiometry (DEXA) for Lumbar spine (BMD), proximal femur (BMD), T-score and Z-score. Fracture risk will be calculated by FRAX score, which estimates a fracture's probability within the next ten years. Physical Performance will be assessed by Time Up and Go Test (TUG), Functional Reach Test, Five Times Sit to Stand Test, Grip strength, Fall Efficacy Scale International, Borg revised category-ratio scale (0 to 10 scale) and Dyspnea index. Urdu Version of ECOS-16 will be used for the evaluation of health-related Quality of life (HRQOL). Data will be analyzed on SPSS-25.

Detailed description: Osteoporosis in Pakistan is estimated at about 9.9 million people, 7.2 million of whom are women. Moreover, an estimated 40 million Pakistanis were equally distributed in Osteopenia between men and women. Osteoporosis prevalence in Pakistan is expected to increase in future years, projected at 11.3 million in 2020 and 12.9 million in 2050. in Pakistan, respectively.

International Osteoporosis Foundation surveyed the Pakistani population in 2009. The findings of this study were based on ultrasound investigations. It was found that 40 million people ranging between 45 and 70 were Osteopenic, while almost 10 million people were found to be Osteoporotic. Osteoporosis's overall prevalence was found to be 16%, while that of Osteopenia was found to be 34%.

Regular exercise involving different functions and subsystems of the human body is beneficial all life. There is ever-growing evidence that exercise prevents at least some harmful effects of Menopause, such as bone loss, increased risk of heart disease, or chronic diseases, such as diabetes.

Wii Fit effectively balances women with bone loss. The purpose of this study was to estimate the effectiveness of a Wii Fit controlled exergame compared with traditional balancing exercises, Quality of life, fear of fall and well-being in bone loss women. The Wii group or control Group comprised thirty-eight female participants aged over 65 years with a bone loss. A supervised Wii fit equilibrium training may be helpful to improve equilibrium issues among women with bone loss.

Bone consistency is greatly affected by physical activity. The following guidelines can be made for physical activity and exercise based on data derived from controlled clinical trials and meta-analyzes (randomized/nonrandomized). 1. Adolescent and prepubertal girls will benefit most from bone loading. Education is an efficient way of growing the peak bone mass of this age group and allows for the prevention of lifelong fractures. 2. Exercises with high impacts, such as jumping or skipping, or strength training paired with movement with high or irregular impacts, are the most powerful for bone.3. In order to preserve or strengthen bone, two to four short workouts (30 mins/day or less) a week for an extended period. 4. Other weight-bearing activities such as resistance training, unique positions of yoga, aerobics, low load, or walking can preserve or boost bone density in older women with risk factors that prevent them from engaging in high impact activities. 5. Additional practices that protect or increase mobility and strength often benefit, as they reduce risk of falling and thus reduce fracture risk.

High-Intensity Resistance and Impact Training (HiRIT) Improves BMD and Physical Function in Postmenopausal Women with Osteopenia and Osteoporosis. A short, controlled, twice-week HiRIT training procedure was productive and superior to previous bone enhancement programs, clinically appropriate locations, stature, functional Performance, and falls in postmenopausal women with low to high bone mass.

Effects of circuit training interventions on bone metabolism markers and bone density of older women with Osteopenia. The conclusion indicated that the circuit training intervention showed positive effects on bone metabolism markers and bone density of older women with Osteopenia, being viewed as an effective intervention program applicable to prevent and control Osteopenia Osteoporosis in line with bone density decrease.

Given the psychological findings, VR exercise has benefited mental stress reduction and HRQOL improvement. Traditional physical therapy can be seen as a repeated and lifeless activity, which also intimidates people. Physical activity (PA) health benefits have been well established in recent decades . Despite its well-known advantages, about 25% of adults and 80% of teenagers worldwide, according to the World Health Organization (WHO), are physically inactive, somewhat through a change in culture and lifestyle. In light of psychological outcomes, VR exercise showed positive impacts on relieving mental tension and improving HRQOL.

Effects of 24 weeks of aerobic dancing on the BMD, physical fitness and health-related Quality of life (HRQOL) in postmenopausal women. The results suggested that 24-week aerobic dance intervention could lower bone fracture incidence by increasing BMD and decreasing fall risk for postmenopausal women. The program adherence in the present study was 81%. Differences were statistically detected in femoral neck BMD, muscle strength and agility.

VR exercise may positively affect the conventional exercise on individual physiological, psychological and rehabilitative outcomes. However, existing studies are far from optimal in terms of consistency, quantity and samples. To confirm these positive effects, therefore, more laborious studies are needed.

Effects of virtual reality training on postmenopausal osteoporotic women. They concluded that virtual reality training has broad beneficial effects on BMD, bone mineral content and Quality of life in postmenopausal osteoporotic women, which may further reduce the risk of osteoporotic fracture. There have been few drawbacks during the whole analysis. The sample was small, and the second sample did not examine the long-term effects of this training. In future studies, the association between BMD and the Quality of life in osteoporotic women after Menopause is proposed.

A Planned, structured and repetitive exercise program is often perceived as boring and hard, thereby causing the individuals to be away from Physical Activity-related behaviours after long days of work. Instead, individuals are more interested in leisure activities, such as video games, where entertainment can be obtained while relaxing. Thus, virtual reality-based video games may trigger their interest, motivation and adherence to exercise. To the best of the researcher's knowledge, no study has investigated the effects of Kinect-based virtual reality training on BMD, fracture risk, physical function, and Quality of life in postmenopausal women with Osteopenia. Although a study has been done to check its effects on postmenopausal women with Osteoporosis; however, considering several limitations in this study, it seemed that more scientific research needs to be done to find out the facts. Asociation between BMD and Quality of life resulting from Kinect-based virtual reality training is also recommended for further research in previous literature. Therefore, the purpose of this study will be to find out the effects of Kinect-based virtual reality training on BMD, future fracture risk, physical function, and Quality of life in postmenopausal women with Osteopenia and to find out the association between BMD and Quality of life. It is hypothesized that Kinect-based virtual reality training for 24 weeks will lead to significant improvements in the outcome measures and will contribute to its role in delaying the progress of Osteopenia to Osteoporosis in postmenopausal women.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Osteopenia verified by dual-energy X-ray absorptiometry with Lumbar spine or femur T-score between -1 to -2.5 either recommended by the study investigators or verified by a physician in the past one year.
* current body mass index (BMI) \< 30 kg/m2
* Patients with Normal balance and no risk of fall checked by Tandem Stance Test (TST)

Exclusion Criteria:

* Impairment of communicative and sensorial functions, Impaired Cognition, and Neurological disorders
* Cardiovascular disease or other chronic conditions that could interfere with their safety during testing or training procedures
* Pulmonary disease requiring oxygen therapy, Symptomatic orthostatic hypotension, Moderate or severe respiratory failure
* secondary osteoporosis, arthrosis or known osteoporotic fractures, neoplastic disease
* Virtual game phobia
* Games used in past six months
* Cases with epilepsy

Primary outcomes:
measure: DUAL-ENERGY X-RAY ABSORPTIOMETRY (DXA)
timeFrame: 6 Months
measure: WHO's FRACTURE RISK ASSESSMENT TOOL (FRAX) ALGORITHM
timeFrame: 6 Months
Secondary outcomes:
measure: TIMED UP AND GO TEST
timeFrame: 6 Months
measure: FUNCTIONAL REACH TEST
timeFrame: 6 Months
measure: MODIFIED SIT AND REACH TEST
timeFrame: 6 Months
measure: FIVE TIMES SIT-TO-STAND TEST
timeFrame: 6 Months
measure: BORG REVISED CATEGORY-RATIO SCALE (0 TO 10 SCALE)
timeFrame: 6 Months
measure: DYSPNEA INDEX
timeFrame: 6 Months
measure: DIGITAL HAND-HELD DYNAMOMETER
timeFrame: 6 Months
measure: QUALITY OF LIFE EVALUATION: ECOS-16 QUESTIONNAIRE
timeFrame: 6 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Genesis Healthcare Consultants
state: Punjab
city: Lahore
country: Pakistan
facility: Riaz
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil Ur Rehman, PhD
role: STUDY_CHAIR
affiliation: Riphah International University
name: Saima Riaz, PhD*
role: PRINCIPAL_INVESTIGATOR
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