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Virtual Reality Exercise on COPD Patient

1 de febrero de 2022 actualizado por: Riphah International University

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Actual)

32

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Punjab
      • Rawalpindi, Punjab, Pakistán
        • Al-Mustafa Trust Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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.
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.
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
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.

¿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
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
30 Second Chair stand test (Senior Fitness Test Battery)
Periodo de tiempo: 2nd week
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
30 Second Chair stand test (Senior Fitness Test Battery)
Periodo de tiempo: 4th week
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
Arm Curl Bicep Test(Senior Fitness Test Battery)
Periodo de tiempo: 0 week
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
Arm Curl Bicep Test(Senior Fitness Test Battery)
Periodo de tiempo: 2nd week
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
Arm Curl Bicep Test(Senior Fitness Test Battery)
Periodo de tiempo: 4th week
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
Chair Sit & reach test(Senior Fitness Test Battery)
Periodo de tiempo: 0 week
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
Chair Sit & reach test(Senior Fitness Test Battery)
Periodo de tiempo: 2nd week
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
Chair Sit & reach test(Senior Fitness Test Battery)
Periodo de tiempo: 4th week
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
Back Scratch Test(Senior Fitness Test Battery)
Periodo de tiempo: 0 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.
0 week
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.
2nd week
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.
4th week
8 Foot up & go test (Senior Fitness Test Battery)
Periodo de tiempo: 0 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.
0 week
8 Foot up & go test (Senior Fitness Test Battery)
Periodo de tiempo: 2nd 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.
2nd week
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.
4th week
6 minute walk Test (Senior Fitness Test Battery)
Periodo de tiempo: 0 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)

0 week
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
6 minute walk Test (Senior Fitness Test Battery)
Periodo de tiempo: 4th 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)

4th week
A Short Questionnaire for Satisfaction Evaluation of Virtual Rehabilitation Systems (USEQ)
Periodo de tiempo: 4th week
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Sumaiyah Obaid, MSPT, Riphah International University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de octubre de 2020

Finalización primaria (Actual)

31 de julio de 2021

Finalización del estudio (Actual)

31 de agosto de 2021

Fechas de registro del estudio

Enviado por primera vez

23 de septiembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

1 de febrero de 2022

Publicado por primera vez (Actual)

10 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

1 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • REC0872 Amna Syed

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Ensayos clínicos sobre EPOC

Ensayos clínicos sobre Virtual Reality

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