- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05234827
Virtual Reality Exercise on COPD Patient
Effects Of Virtual Reality Based Rehabilitation Program On Physical Fitness In Patient With Chronic Obstructive Pulmonary Disorders
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab
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Rawalpindi, Punjab, 파키스탄
- Al-Mustafa Trust Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Virtual Reality
VR 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.
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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 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.
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활성 비교기: Control
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
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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 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
30 Second Chair stand test (Senior Fitness Test Battery)
기간: 0 week
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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.
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0 week
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30 Second Chair stand test (Senior Fitness Test Battery)
기간: 2nd week
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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.
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2nd week
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30 Second Chair stand test (Senior Fitness Test Battery)
기간: 4th week
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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.
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4th week
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Arm Curl Bicep Test(Senior Fitness Test Battery)
기간: 0 week
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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.
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0 week
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Arm Curl Bicep Test(Senior Fitness Test Battery)
기간: 2nd week
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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.
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2nd week
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Arm Curl Bicep Test(Senior Fitness Test Battery)
기간: 4th week
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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.
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4th week
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Chair Sit & reach test(Senior Fitness Test Battery)
기간: 0 week
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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.
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0 week
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Chair Sit & reach test(Senior Fitness Test Battery)
기간: 2nd week
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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.
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2nd week
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Chair Sit & reach test(Senior Fitness Test Battery)
기간: 4th week
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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.
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4th week
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Back Scratch Test(Senior Fitness Test Battery)
기간: 0 week
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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.
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0 week
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Back Scratch Test(Senior Fitness Test Battery)
기간: 2nd week
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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.
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2nd week
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Back Scratch Test(Senior Fitness Test Battery)
기간: 4th week
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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.
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4th week
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8 Foot up & go test (Senior Fitness Test Battery)
기간: 0 week
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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.
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0 week
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8 Foot up & go test (Senior Fitness Test Battery)
기간: 2nd week
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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.
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2nd week
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8 Foot up & go test (Senior Fitness Test Battery)
기간: 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.
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4th week
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6 minute walk Test (Senior Fitness Test Battery)
기간: 0 week
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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
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6 minute walk Test (Senior Fitness Test Battery)
기간: 2nd week
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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
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6 minute walk Test (Senior Fitness Test Battery)
기간: 4th week
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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
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A Short Questionnaire for Satisfaction Evaluation of Virtual Rehabilitation Systems (USEQ)
기간: 4th week
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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.
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4th week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sumaiyah Obaid, MSPT, Riphah International University
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- Rutkowski S, Szczegielniak J, Szczepańska-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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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