Effects of VR Training on Balance and Fall Risk of Patients With COPD

NCT06604754 | Completed DMC

• 1 other identifier: Syeda Marium Nadeem
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether Virtual Reality (VR) training has significant effects on balance and fall risk of patients with COPD, with a focus on the patient group (GOLD STANDARD I \& II). Additionally, the study determines whether VR training is a reliable substitute for traditional physical therapy balance.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; VR; BBS

Outcome Measures

Primary Outcomes (6)

• Balance

  Berg Balance Scale (BBS) is used to assess balance. It consists of a 14 item that evaluates a persons performance on particular functional task.

  8 weeks

• Functional Capacity

  The Six Minute Walk Test (SMWT) is a widely used tool for assessing functional exercise capacity, especially in populations with pulmonary and cardiovascular conditions. The test is performed under controlled conditions with the patient encouraged to perform at their own pace and take breaks if needed. the distance covered is measured and any change in condition or symptoms are noted.

  8 weeks

• Peak Expiratory Flow rate

  Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings

  8 weeks

• Forced Vital Capacity

  Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.

  8 weeks

• Forced Expiratory Volume in 1sec

  Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.

  8 weeks

• FVC/FEV1 ratio

  The FVC/FEV1 ratio is crucial for differentiating between obstructive and restrictive lung patterns. It helps in diagnosing conditions like asthma and COPD, and in monitoring the progression or improvement of these diseases. In clinical practice, this ratio is used alongside other spirometric measurements and patient history to provide a comprehensive assessment of lung function.

  8 weeks

Study Arms (2)

Virtual Reality Based Training

EXPERIMENTAL

Virtual reality (VR) based balance training utilizes immersive digital environments to enhance balance and stability through interactive and engaging exercises. Patients wear VR headsets that create realistic scenarios where they perform various balance tasks, such as navigating virtual obstacles or maintaining stability on unstable surfaces. This technology offers the advantage of providing controlled, adjustable challenges that can be tailored to the patient's specific needs and progress. VR training often incorporates real-time feedback, which helps patients improve their balance in a motivating and dynamic setting.

Other: Assigned Intervention for VR Training

Traditional Physical Therapy Based Training:

ACTIVE COMPARATOR

Traditional physical therapy-based balance training focuses on improving stability and preventing falls through a variety of exercises and techniques. It typically begins with a comprehensive assessment to identify balance issues and set individualized goals. The training includes static exercises like single-leg stands, dynamic activities such as walking on uneven surfaces, and strengthening and flexibility exercises to enhance muscle control and range of motion. Coordination and functional training, including gait and daily activity simulation, are also integral. Additionally, patients receive education on fall prevention strategies and home safety. Regular monitoring ensures that the program is adjusted to the patient's progress and ongoing needs, ultimately enhancing balance and reducing fall risk.

Other: Assigned Intervention for Traditional Physical Therapy Training

Interventions

Assigned Intervention for VR Training OTHER

In VR training patients use VR headsets to engage in virtual environments for 8 weeks where they perform exercises designed to enhance balance, coordination, and strength. Simultaneously, the VR platform incorporate pulmonary exercises that focus on improving breathing techniques, lung capacity, and overall respiratory health. Patients will engage in 3 sessions per week with total time duration of 45 to 60 minutes. VR-based training provides real-time feedback and adapts to the patient's progress, offering a comprehensive approach to rehabilitation that addresses both balance and pulmonary function in a motivating and controlled manner.

Virtual Reality Based Training

Assigned Intervention for Traditional Physical Therapy Training OTHER

In Traditional physical therapy balance training for patients with chronic obstructive pulmonary disease (COPD) involves exercises designed to improve stability, strength, and coordination for duration of 8 weeks. These exercises, such as static balance tasks, dynamic movement drills, and strength training, help address the balance deficits often seen in COPD patients due to muscle weakness and reduced physical activity. Additionally, pulmonary effects are managed through breathing exercises such as deep breathing and pursed lip breathing that enhance respiratory functions, improve lung capacity and efficiency.

Traditional Physical Therapy Based Training:

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both Male and Female
• Diagnosed with mild to moderate COPD (GOLD stages I-II)
• Age between 40-65 years
• BBS score above 35 will be included.
• COPD patients with oxygen saturation of above 88%.
• Patients able to follow instructions / commands.

You may not qualify if:

• Recent exacerbation of COPD requiring hospitalization within last 4 weeks.
• Diagnosed with severe cognitive impairments.
• Previous experience with VR-based rehabilitation.
• Use of medication that could affect exercise response.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46300, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suman Sheraz, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 19, 2024
• Study Start: June 12, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)