Effects of Kinect-based Virtual Reality Training in Postmenopausal Women With Osteopenia

NCT04862910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-11-13

No results posted yet for this study

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.

Conditions

  • Postmenopausal Osteopenia

Interventions

OTHER

Kinect Based Virtual Reality Training

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.

OTHER

Control Group

* They will be instructed to walk outdoors daily for 30 Minutes. * They will continue their daily activities with a routine diet and routine Medication

Sponsors & Collaborators

  • Riphah International University

    lead OTHER

Principal Investigators

  • Syed Shakil Ur Rehman, PhD · Riphah International University

  • Saima Riaz, PhD* · Riphah International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-06-01
Completion
2023-06-15

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862910 on ClinicalTrials.gov