跳至主要内容
临床试验/NCT04862910
NCT04862910已完成不适用

Effects of Kinect-based Virtual Reality Training on Bone Mineral Density, Fracture Risk, Physical Performance and Quality of Life in Postmenopausal Women With Osteopenia

Riphah International University4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
4
主要终点
WHO's FRACTURE RISK ASSESSMENT TOOL (FRAX) ALGORITHM

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Double Blinded

入排标准

年龄范围
48 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

WHO's FRACTURE RISK ASSESSMENT TOOL (FRAX) ALGORITHM

时间窗: 6 Months

FRAX, released in 2008 by the World Health Organization, was developed and validated under the direction of Professor John Kanis with the support of many individuals and organizations, including the American Society for Bone and Mineral Research, the National Osteoporosis Foundation, the International Society for Clinical Densitometry, and the International Osteoporosis Foundation.It calculates the 10-YEAR PROBABILITY OF OSTEOPOROTIC FRACTURE using WHO's fracture Assessment calculator with age, sex, weight, height, clinical risk factors, and femoral neck BMD.

DUAL-ENERGY X-RAY ABSORPTIOMETRY (DXA)

时间窗: 6 Months

The most commonly used Gold standard BMD test is a densitometric technique called DXA (dual-energy X-ray absorptiometry), which can be measured in vivo and validated by many studies for BMD, T-score and Z-Score.

次要结局

  • BORG REVISED CATEGORY-RATIO SCALE (0 TO 10 SCALE)(6 Months)
  • DYSPNEA INDEX(6 Months)
  • TIMED UP AND GO TEST(6 Months)
  • FUNCTIONAL REACH TEST(6 Months)
  • MODIFIED SIT AND REACH TEST(6 Months)
  • FIVE TIMES SIT-TO-STAND TEST(6 Months)
  • DIGITAL HAND-HELD DYNAMOMETER(6 Months)
  • QUALITY OF LIFE EVALUATION: ECOS-16 QUESTIONNAIRE(6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验

Effects of Kinect-based Virtual Reality Training in... | 临床试验