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COPDNCT05234827

Virtual Reality Exercise on COPD Patient

A study testing Virtual Reality in people with COPD, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
COPD
What is being tested?
Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
16 Oct 2020to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pneumonia, tuberculosis, and other respiratory
  • inflammatory disease
  • Heart Failure
  • Advanced Uncontrolled Hypertension
  • Post Cardiac or Thoracic Surgery (< 6 Months)
  • Neuromuscular Disorders
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Al-Mustafa Trust Medical Center

    Rawalpindi, Punjab Province

Other trials in Pakistan

About this study

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

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.

Read the detailed 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

Conditions
COPD
Being tested
Virtual Reality, Control
Keywords
physical fitness, Virtual reality, rehabilitation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityOther

    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.

  • ControlOther

    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.

Study groups in NCT05234827
Study groupRoleWhat they receive
Virtual RealityExperimentalVR sessions include a device (XBOX 360) and motion sensor (Kinect) and LED (tv screen) with speakers attached. Height of the device is 1m while tv screen is placed 2.5m away, motion sensor is placed 1.2m away from the patient, play area should be 1.8m wide and long. Instruction to play game is provided to each patient. Before starting each training session, the device was adjusted to correctly follow the movements of each patient. VR session includes games by Kinect Adventures (Microsoft games studios, Washington, US) which include minigames in which patients participated these mini games are 20000 Leaks, Curvy Creek, Rally Ball and Reflux Ridge.
Receives: Other: Virtual Reality; Other: Control
ControlActive comparatorTotal 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
Receives: Other: Virtual Reality; Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 week

  2. 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.

    Measured: 2nd week

  3. 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.

    Measured: 4th week

  4. 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.

    Measured: 0 week

  5. 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.

    Measured: 2nd week

  6. 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.

    Measured: 4th week

  7. 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.

    Measured: 0 week

  8. 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.

    Measured: 2nd week

  9. 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.

    Measured: 4th week

  10. 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.

    Measured: 0 week

  11. 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.

    Measured: 2nd week

  12. 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.

    Measured: 4th week

  13. 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.

    Measured: 0 week

  14. 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.

    Measured: 2nd week

  15. 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.

    Measured: 4th week

  16. 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)

    Measured: 0 week

  17. 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)

    Measured: 2nd week

  18. 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)

    Measured: 4th week

  19. 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.

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start16 Oct 2020
  3. Primary completion31 Jul 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234827
Sponsor's protocol ID
REC0872 Amna Syed
Status last verified
Feb 2022
First submitted
23 Sep 2021
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32021150
  • 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.

    PubMed 27225143
  • 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):352. doi: 10.3390/jcm10020352.

    PubMed 33477733

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality in people with COPD, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 Second Chair stand test (Senior Fitness Test Battery) (time frame: 0 week). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05234827, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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