Effects of Kinect-based Virtual Reality Training in Postmenopausal Women With Osteopenia
Condition: Postmenopausal Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional

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.
    

Intervention name(s): Kinect Based Virtual Reality Training; Control Group
Intervention type(s): Other; Other
Intervention description(s): The participant will receive the game instructions from the examiner.Protocol will be implemented 3 steps Warm Up phase Activity phase and cool down phase. The games will be played under the supervision and guidance of the therapist.Games are selected from Kinect games Kinect Sports Kinect Adventures and Your Shape Fitness Evolved. Three treatment sessions per week will be given to each participant. Total duration of each treatment session will be 45 Minutes.Participants will be instructed to walk outdoors for 30 Minutes daily. Routine Medication and routine diet will be continued.; They will be instructed to walk outdoors daily for 30 Minutes.
They will continue their daily activities with a routine diet and routine Medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postmenopausal Osteopenia; Bone Mineral Density; Virtual Reality; Fracture; Quality of Life