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

NCT04862910 | Completed

• 1 other identifier: REC/Lhr/21/1102/B Saima Riaz
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Postmenopausal Osteopenia

Keywords

Postmenopausal Osteopenia; Bone Mineral Density; Virtual Reality; Fracture; Quality of Life

Outcome Measures

Primary Outcomes (2)

• DUAL-ENERGY X-RAY ABSORPTIOMETRY (DXA)

  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.

  6 Months

• WHO's FRACTURE RISK ASSESSMENT TOOL (FRAX) ALGORITHM

  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.

  6 Months

Secondary Outcomes (8)

• 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

• BORG REVISED CATEGORY-RATIO SCALE (0 TO 10 SCALE)

  6 Months

Study Arms (2)

Kinect Based Virtual Reality Training

EXPERIMENTAL

Kinect-Based Virtual Reality Training 30 Minutes walk outdoor Routine Medication and routine diet will be continued.

Other: Kinect Based Virtual Reality Training

Control Group

OTHER

30 Minutes walk outdoor Regular active life style Routine diet and routine Medication

Other: Control Group

Interventions

Kinect Based Virtual Reality Training OTHER

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.

Kinect Based Virtual Reality Training

Control Group OTHER

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

Control Group

Eligibility Criteria

• Age: 48 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Genesis Healthcare Consultants

Lahore, Punjab Province, 54000, Pakistan

Location

Riaz

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (19)

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  PMID: 15291959 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Syed Shakil Ur Rehman, PhD

  Riphah International University

  STUDY CHAIR

• Saima Riaz, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 15, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)