- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05234827
Virtual Reality Exercise on COPD Patient
Effects Of Virtual Reality Based Rehabilitation Program On Physical Fitness In Patient With Chronic Obstructive Pulmonary Disorders
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab
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Rawalpindi, Punjab, Pakistán
- Al-Mustafa Trust Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
30 Second Chair stand test (Senior Fitness Test Battery)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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2nd week
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Back Scratch Test(Senior Fitness Test Battery)
Periodo de tiempo: 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.
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4th week
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8 Foot up & go test (Senior Fitness Test Battery)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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) |
2nd week
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6 minute walk Test (Senior Fitness Test Battery)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sumaiyah Obaid, MSPT, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- REC0872 Amna Syed
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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