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Completed

NCT Number: NCT05234827

Virtual Reality Exercise on COPD Patient

The program allows the patient to interact with the simulated VR technology using motion sensors, focusing on patients' fitness through various tests providing them a clinically stable environment; to counter moderate level of diseases according to GOLD criteria and to monitor the effects of exercise program on dyspnea. The purpose of this study is to facilitate the patients so that they get acquainted with the digital technology with significant contribution towards pulmonary rehabilitation program for COPD patients. It also analysis the satisfaction of the patients and encourages the use of emerging technology integrated with clinical trials.

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Key information

Conditions

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

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Mustafa Trust Medical Center

Rawalpindi, Punjab Province, Pakistan

About this study

Chronic obstructive lung disease (COPD) is a reversible lung disease which is a principal cause of morbidity and mortality worldwide. It is the third leading cause of death worldwide according to the reports of American Thoracic Society (ATS) and European- Respiratory Society. According to World Health Organization (WHO), every year death and in 2030 it will become the third most common cause of death. COPD risk factors includes smoking tobacco, exposure to dusts, hereditary predisposition, and fumes, indoor and outdoor air pollutants, ageing, and asthma. Out of all these risk factors, the main reason that develops COPD fastest is smoking which is further linked with depression

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:50-70 years
  • Both genders
  • Clinical Signs and Symptoms of Moderate COPD (GOLD Criteria)
  • Clinically Stable
  • Ratio of FEV1/ FVC is <0.7
  • Reported Smoking History

Exclusion criteria

  • Pneumonia, tuberculosis, and other respiratory
  • inflammatory disease
  • Heart Failure
  • Advanced Uncontrolled Hypertension
  • Post Cardiac or Thoracic Surgery (< 6 Months)
  • Neuromuscular Disorders
  • Metal Implant in Lower Limb
  • Cardiac Pacemaker
  • Cognitive Dysfunction or Mini-Mental Scale Scores <24
  • Long- term Non-Invasive Ventilation
  • Comorbidity that could Limit Exercise Testing and Training i.e., Arthritis, Osteoporosis, Fracture, Diabetic Neuropathy etc.

Treatment and study plan

Virtual Reality

Other

Total time duration for session is 40 minutes which includes 5 min of warm exercises which include heel raises, arm circles, side leg raises, trunk rotation, elbow flexion and extension, knee flexion and extension, and shoulder internal and external rotation, 30 minutes of VR session and 5-7 min of cool down exercises which include full body stretches i.e., toe touching, pectoralis major stretch, side by side bending, quadricep stretch, hamstring stretch, trapezius stretch and deep breathing.

Control

Other

Control group receive endurance exercise testing in which stationary cycle is used for 30 min per session. It includes lower extremity strengthening i.e., increases hamstring and quadricep strength. Total time duration for session is 40 minutes in which 5 min of warm up exercises which include heel raises, arm circles, side leg raises, trunk rotation, elbow flexion and extension, knee flexion and extension, and shoulder internal and external rotation, 30 min of bicycling and after that 5-7 min of cool down exercises which include full body stretches i.e., toe touching, pectoralis major stretch, side by side bending, quadricep stretch, hamstring stretch, trapezius stretch and deep breathing.

Primary outcomes

  1. 30 Second Chair stand test (Senior Fitness Test Battery)

    Time frame: 0 week

    To measure the leg strength and endurance. The chair stand test is similar to a squat test to measure leg strength, in which participants stand up repeatedly from a chair for 30 seconds. Its category scoring based on the seconds, below average (<14), average (14 to 19) and above average (>19). Assessment done on baseline, 2nd week and fourth week.

  2. 30 Second Chair stand test (Senior Fitness Test Battery)

    Time frame: 2nd week

    To measure the leg strength and endurance. The chair stand test is similar to a squat test to measure leg strength, in which participants stand up repeatedly from a chair for 30 seconds. Its category scoring based on the seconds, below average (<14), average (14 to 19) and above average (>19).Assessment done on baseline, 2nd week and fourth week.

  3. 30 Second Chair stand test (Senior Fitness Test Battery)

    Time frame: 4th week

    To measure the leg strength and endurance. The chair stand test is similar to a squat test to measure leg strength, in which participants stand up repeatedly from a chair for 30 seconds. Its category scoring based on the seconds, below average (<14), average (14 to 19) and above average (>19).Assessment done on baseline, 2nd week and fourth week. Assessment done on baseline, 2nd week and 4th week.

  4. Arm Curl Bicep Test(Senior Fitness Test Battery)

    Time frame: 0 week

    Test to measure the upper body strength and endurance. The aim of this test is to do as many arm curls as possible in 30 seconds. This test is conducted on the dominant arm side (or stronger side).5 pound weight (women, SFT), 8 pound weight (for men). A chair without armrests, stopwatch. The measurement according to complete in seconds below average (<16), average (16 to 22) and above average (>22). Assessment done on baseline, 2nd week and 4th week.

  5. Arm Curl Bicep Test(Senior Fitness Test Battery)

    Time frame: 2nd week

    Test to measure the upper body strength and endurance. The aim of this test is to do as many arm curls as possible in 30 seconds. This test is conducted on the dominant arm side (or stronger side).5 pound weight (women, SFT), 8 pound weight (for men). A chair without armrests, stopwatch. The measurement according to complete in seconds below average (<16), average (16 to 22) and above average (>22). Assessment done on baseline, 2nd week and 4th week.

  6. Arm Curl Bicep Test(Senior Fitness Test Battery)

    Time frame: 4th week

    Test to measure the upper body strength and endurance. The aim of this test is to do as many arm curls as possible in 30 seconds. This test is conducted on the dominant arm side (or stronger side).5 pound weight (women, SFT), 8 pound weight (for men). A chair without armrests, stopwatch. The measurement according to complete in seconds below average (<16), average (16 to 22) and above average (>22). Assessment done on baseline, 2nd week and 4th week.

  7. Chair Sit & reach test(Senior Fitness Test Battery)

    Time frame: 0 week

    The Chair Sit and Reach test is part of the Senior Fitness Test Protocol, and is designed to test the functional fitness of seniors. This test measures lower body flexibility. The score is recorded to the nearest 1/2 inch or 1 cm as the distance reached, either a negative or positive score. Assessment done on baseline, 2nd week and 4th week.

  8. Chair Sit & reach test(Senior Fitness Test Battery)

    Time frame: 2nd week

    The Chair Sit and Reach test is part of the Senior Fitness Test Protocol, and is designed to test the functional fitness of seniors. This test measures lower body flexibility. The score is recorded to the nearest 1/2 inch or 1 cm as the distance reached, either a negative or positive score. Assessment done on baseline, 2nd week and 4th week.

  9. Chair Sit & reach test(Senior Fitness Test Battery)

    Time frame: 4th week

    The Chair Sit and Reach test is part of the Senior Fitness Test Protocol, and is designed to test the functional fitness of seniors. This test measures lower body flexibility. The score is recorded to the nearest 1/2 inch or 1 cm as the distance reached, either a negative or positive score. Assessment done on baseline, 2nd week and 4th week.

  10. Back Scratch Test(Senior Fitness Test Battery)

    Time frame: 0 week

    The Scratch Test, measures how close the hands can be brought together behind the back. This test is part of the Senior Fitness Test Protocol, and is designed to test the functional fitness of seniors. This test measures general shoulder range of motion. Record the best score to the nearest centimeter or 1/2 inch. The higher the score the better the result. Below is a table showing the recommended ranges (in inches) for this test based on age groups (from Jones & Rikli, 2002). Assessment done on baseline, 2nd week and 4th week.

  11. Back Scratch Test(Senior Fitness Test Battery)

    Time frame: 2nd week

    The Scratch Test, measures how close the hands can be brought together behind the back. This test is part of the Senior Fitness Test Protocol, and is designed to test the functional fitness of seniors. This test measures general shoulder range of motion. Record the best score to the nearest centimeter or 1/2 inch. The higher the score the better the result. Below is a table showing the recommended ranges (in inches) for this test based on age groups (from Jones & Rikli, 2002). Assessment done on baseline, 2nd week and 4th week.

  12. Back Scratch Test(Senior Fitness Test Battery)

    Time frame: 4th week

    The Scratch Test, measures how close the hands can be brought together behind the back. This test is part of the Senior Fitness Test Protocol, and is designed to test the functional fitness of seniors. This test measures general shoulder range of motion. Record the best score to the nearest centimeter or 1/2 inch. The higher the score the better the result. Below is a table showing the recommended ranges (in inches) for this test based on age groups (from Jones & Rikli, 2002). Assessment done on baseline, 2nd week and 4th week.

  13. 8 Foot up & go test (Senior Fitness Test Battery)

    Time frame: 0 week

    The '8 Foot Up-and-Go' is a coordination and agility test for the elderly, which is part of the Senior Fitness Test Protocol. This test measures speed, agility and balance while moving. Take the best time of the two trails to the nearest 1/10th second. Below is a table showing the recommended ranges in seconds for this test based on age groups (from Jones & Rikli, 2002). Assessment done on baseline, 2nd week and 4th week.

  14. 8 Foot up & go test (Senior Fitness Test Battery)

    Time frame: 2nd week

    The '8 Foot Up-and-Go' is a coordination and agility test for the elderly, which is part of the Senior Fitness Test Protocol. This test measures speed, agility and balance while moving. Take the best time of the two trails to the nearest 1/10th second. Below is a table showing the recommended ranges in seconds for this test based on age groups (from Jones & Rikli, 2002). Assessment done on baseline, 2nd week and 4th week.

  15. 8 Foot up & go test (Senior Fitness Test Battery)

    Time frame: 4th week

    The '8 Foot Up-and-Go' is a coordination and agility test for the elderly, which is part of the Senior Fitness Test Protocol. This test measures speed, agility and balance while moving. Take the best time of the two trails to the nearest 1/10th second. Below is a table showing the recommended ranges in seconds for this test based on age groups (from Jones & Rikli, 2002). Assessment done on baseline, 2nd week and 4th week.

  16. 6 minute walk Test (Senior Fitness Test Battery)

    Time frame: 0 week

    The 6 Minute Walk test (6MWT) is designed to test the functional fitness of seniors. The aim of this test is to walk as quickly as possible for six minutes to cover as much ground as possible. measure the distance walked in 6 minutes to the nearest meter. The following regression equations were determined by Jenkins et al. (2009). Assessment done on baseline, 2nd week and 4th week.

    males: Walk Distance (meters) = 867 - (5.71 age, yrs) + (1.03 height, cm) females: Walk Distance (meters) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI)

  17. 6 minute walk Test (Senior Fitness Test Battery)

    Time frame: 2nd week

    The 6 Minute Walk test (6MWT) is designed to test the functional fitness of seniors. The aim of this test is to walk as quickly as possible for six minutes to cover as much ground as possible. measure the distance walked in 6 minutes to the nearest meter. The following regression equations were determined by Jenkins et al. (2009). Assessment done on baseline, 2nd week and 4th week.

    males: Walk Distance (meters) = 867 - (5.71 age, yrs) + (1.03 height, cm) females: Walk Distance (meters) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI)

  18. 6 minute walk Test (Senior Fitness Test Battery)

    Time frame: 4th week

    The 6 Minute Walk test (6MWT) is designed to test the functional fitness of seniors. The aim of this test is to walk as quickly as possible for six minutes to cover as much ground as possible. measure the distance walked in 6 minutes to the nearest meter. The following regression equations were determined by Jenkins et al. (2009). Assessment done on baseline, 2nd week and 4th week.

    males: Walk Distance (meters) = 867 - (5.71 age, yrs) + (1.03 height, cm) females: Walk Distance (meters) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI)

  19. A Short Questionnaire for Satisfaction Evaluation of Virtual Rehabilitation Systems (USEQ)

    Time frame: 4th week

    It is necessary to evaluate the experience of individual whenever someone uses any system up to what extent user achieve goal with its effects and efficiency and satisfaction so that quality of user experience can be measure be and it is known as usability.(73) proper environment, product and instruction is required to obtain good usability of a system. One of the emerging technologies in the field of rehabilitation for different pathologies is virtual rehabilitation. Assessment done on 4th week.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects Of Virtual Reality Based Rehabilitation Program On Physical Fitness In Patient With Chronic Obstructive Pulmonary Disorders

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2022
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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