Virtual Reality Exercise on COPD Patient

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234827
• Other study ID #: REC0872 Amna Syed
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Virtual Reality
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
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.

Locations

Country	Name	City	State
Pakistan	Al-Mustafa Trust Medical Center	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Nafees AA, Fatmi Z, Kadir MM, Sathiakumar N. Chronic Bronchitis and Chronic Obstructive Pulmonary Disease (COPD) Among Textile Workers in Karachi, Pakistan. J Coll Physicians Surg Pak. 2016 May;26(5):384-9. doi: 2320. — View Citation

Rutkowski S, Rutkowska A, Kiper P, Jastrzebski D, Racheniuk H, Turolla A, Szczegielniak J, Casaburi R. Virtual Reality Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Jan 13;15:117-124. doi: 10.2147/COPD.S223592. eCollection 2020. — View Citation

Rutkowski S, Szczegielniak J, Szczepanska-Gieracha J. Evaluation of the Efficacy of Immersive Virtual Reality Therapy as a Method Supporting Pulmonary Rehabilitation: A Randomized Controlled Trial. J Clin Med. 2021 Jan 18;10(2). pii: 352. doi: 10.3390/jcm10020352. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 Second Chair stand test (Senior Fitness Test Battery)	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.	0 week
Primary	30 Second Chair stand test (Senior Fitness Test Battery)	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.	2nd week
Primary	30 Second Chair stand test (Senior Fitness Test Battery)	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.	4th week
Primary	Arm Curl Bicep Test(Senior Fitness Test Battery)	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.	0 week
Primary	Arm Curl Bicep Test(Senior Fitness Test Battery)	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.	2nd week
Primary	Arm Curl Bicep Test(Senior Fitness Test Battery)	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.	4th week
Primary	Chair Sit & reach test(Senior Fitness Test Battery)	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.	0 week
Primary	Chair Sit & reach test(Senior Fitness Test Battery)	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.	2nd week
Primary	Chair Sit & reach test(Senior Fitness Test Battery)	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.	4th week
Primary	Back Scratch Test(Senior Fitness Test Battery)	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.	0 week
Primary	Back Scratch Test(Senior Fitness Test Battery)	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.	2nd week
Primary	Back Scratch Test(Senior Fitness Test Battery)	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.	4th week
Primary	8 Foot up & go test (Senior Fitness Test Battery)	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.	0 week
Primary	8 Foot up & go test (Senior Fitness Test Battery)	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.	2nd week
Primary	8 Foot up & go test (Senior Fitness Test Battery)	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.	4th week
Primary	6 minute walk Test (Senior Fitness Test Battery)	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)	0 week
Primary	6 minute walk Test (Senior Fitness Test Battery)	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)	2nd week
Primary	6 minute walk Test (Senior Fitness Test Battery)	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)	4th week
Primary	A Short Questionnaire for Satisfaction Evaluation of Virtual Rehabilitation Systems (USEQ)	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.	4th week