Clinical trial NCT05234827: Virtual Reality Exercise on COPD Patient
Official title: Effects Of Virtual Reality Based Rehabilitation Program On Physical Fitness In Patient With Chronic Obstructive Pulmonary Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: physical fitness
Virtual reality
rehabilitation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: 30 Second Chair stand test (Senior Fitness Test Battery)
timeFrame: 0 week
measure: 30 Second Chair stand test (Senior Fitness Test Battery)
timeFrame: 2nd week
measure: 30 Second Chair stand test (Senior Fitness Test Battery)
timeFrame: 4th week
measure: Arm Curl Bicep Test(Senior Fitness Test Battery)
timeFrame: 0 week
measure: Arm Curl Bicep Test(Senior Fitness Test Battery)
timeFrame: 2nd week
measure: Arm Curl Bicep Test(Senior Fitness Test Battery)
timeFrame: 4th week
measure: Chair Sit & reach test(Senior Fitness Test Battery)
timeFrame: 0 week
measure: Chair Sit & reach test(Senior Fitness Test Battery)
timeFrame: 2nd week
measure: Chair Sit & reach test(Senior Fitness Test Battery)
timeFrame: 4th week
measure: Back Scratch Test(Senior Fitness Test Battery)
timeFrame: 0 week
measure: Back Scratch Test(Senior Fitness Test Battery)
timeFrame: 2nd week
measure: Back Scratch Test(Senior Fitness Test Battery)
timeFrame: 4th week
measure: 8 Foot up & go test (Senior Fitness Test Battery)
timeFrame: 0 week
measure: 8 Foot up & go test (Senior Fitness Test Battery)
timeFrame: 2nd week
measure: 8 Foot up & go test (Senior Fitness Test Battery)
timeFrame: 4th week
measure: 6 minute walk Test (Senior Fitness Test Battery)
timeFrame: 0 week
measure: 6 minute walk Test (Senior Fitness Test Battery)
timeFrame: 2nd week
measure: 6 minute walk Test (Senior Fitness Test Battery)
timeFrame: 4th week
measure: A Short Questionnaire for Satisfaction Evaluation of Virtual Rehabilitation Systems (USEQ)
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Al-Mustafa Trust Medical Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sumaiyah Obaid, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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):352. doi: 10.3390/jcm10020352.