Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05839262
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-03-15
Brief Title:
Active Video Games for Older Adults With Knee andor Hip Osteoarthritis
Sponsor:
Cristian Alvarez
Organization:
Universidad Nacional Andres Bello
Study Overview
Official Title:
Physical Exercise Guided by Active Video Games for Optimizing Clinical and Psychosocial Outcomes in Older Adults With Knee andor Hip Osteoarthritis Under a Community-based Rehabilitation Model
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Population aging is currently an issue of primary relevance constituting an enormous challenge for institutions and society On the other hand osteoarthritis OA is the most prevalent arthropathy in the elderly strongly related to loss of functional capacity limitation of daily activities increased musculoskeletal pain and deterioration of quality of life More specifically knee and hip OA represent a significant burden for health systems and in Chile they are among the ten most frequent diseases in the elderly The technological development of the last decades has allowed the incorporation of several therapeutic alternatives for the intervention of the elderly such as virtual reality which allows interaction with multiple digital environments Active video games AVG or exergames carried out through commercial non-immersive virtual reality systems have been proposed as a feasible innovative and entertaining alternative to optimize conventional physical rehabilitation CPR AVG in healthy older people and those with neurocognitive conditions effectively improves clinical and psychosocial outcomes However it has been recommended to advance the study of the effects of AVGs in people with musculoskeletal pathologies such as knee and hip OA Accordingly the purpose is to analyze the effects of an AVG-guided physical exercise protocol adjunct to CPR on functional mobility in older adults with knee andor hip OA
Detailed Description:
Osteoarthritis OA is highly prevalent and its incidence increases with aging populations OA is characterized by articular cartilage degeneration stiffness inflammation and musculoskeletal pain In addition the associated deterioration of health-related quality of life may influence therapeutic adherence and progression to future joint replacement It appears that symptoms rather than structural impairment determine the risk of falling in older people with OA so pain loss of strength and postural balance are underlying mechanisms for both falls and the clinical picture of OA itself Moreover the psychosocial sequelae are often underestimated because OA and pain are usually considered benign and unavoidable consequences of aging
Physical exercise in people with knee and hip OA improves clinical aspects and psychosocial aspects such as self-efficacy social function and reduction of depression and isolation among others Adherence to exercise is fundamental and is closely related to user satisfaction There are several barriers to physical exercise by older adults such as lack of social support transportation problems and prioritization of basic needs however a determining factor is lack of motivation In this regard a study indicates that in Latin America lack of motivation is among the main reasons for abandoning physical exercise
The technological development of the last decades has allowed the incorporation of virtual reality into the healthcare field favoring user motivation Virtual reality is an experience based on the interactive digital simulation of environments and objects These systems are categorized as non-immersive semi-immersive and immersive Non-immersive systems use monitors or television screens semi-immersive systems use panoramic screens to enhance the immersive experience and immersive systems use head-mounted displays or multi-projected environments that generate a strong sense of immersion It has been posited that the cost and expertise required to operate immersive systems may hinder their widespread use in clinical settings In addition the immersive sensation could produce symptoms such as visual fatigue and dizziness cybersickness On the other hand non-immersive systems using commercially available home consoles are now considered an attractive and more accessible alternative to more sophisticated immersive systems
Unlike traditional video games that use a standard command or joystick active video games AVGs also called exergames use motion monitoring systems such as accelerometers gyroscopes haptic technology and video capture AVGs have been defined as a combination of video game technologies and exercise routines to motivate physical activity among individuals or groups recognizing that exercise in older people requires a greater understanding of the complexity of interaction with computer systems
Conventional physical rehabilitation CPR consists of traditional physical exercises that improve functional capacity Over the past few years it has been suggested that incorporating AVGs into CPR can optimize clinical and psychosocial outcomes in the elderly AVGs have been reported to promote improvements in functional mobility coordination muscle strength and cognitive function in older people In addition AVGs improve walking ability and postural balance as well as social well-being perception of loneliness social connectedness and positive attitudes However this research has focused on healthy elderly and patients with neurocognitive pathologies On the other hand little information is available on older people with musculoskeletal conditions such as OA In this regard a systematic review conducted in patients with knee andor hip OA indicates that the evidence is insufficient and inconclusive regarding the effectiveness of AVGs Moreover one study concludes that AVGs are a feasible and acceptable intervention for patients with knee OA Interestingly both studies raise the benefits and potential of AVGs in this population urging further clinical trials
Research question In older adults with knee andor hip OA Is AVG-guided physical exercise adjunct to CPR more effective than CPR alone in improving clinical and psychosocial outcomes
Working hypothesis In older adults with knee andor hip OA AVG-guided physical exercise adjunct to CPR is more effective than CPR alone in improving clinical and psychosocial outcomes
General objective To determine the effects of an AVG-guided physical exercise program adjunct to CPR on clinical and psychosocial outcomes in older adults with knee andor hip OA attended at a community-based family health center
Specific objectives
1 To characterize the study sample from sociodemographic anthropometric clinical and psychosocial perspectives
2 To compare the results of the primary outcome functional mobility and secondary outcomes between the study groups experimental and control in the different instances of outcome measurement
3 To evaluate the clinical significance of the interventions and the clinical relevance of the interventions as perceived by the participants
Physical exercise in people with knee and hip OA improves clinical aspects and psychosocial aspects such as self-efficacy social function and reduction of depression and isolation among others Adherence to exercise is fundamental and is closely related to user satisfaction There are several barriers to physical exercise by older adults such as lack of social support transportation problems and prioritization of basic needs however a determining factor is lack of motivation In this regard a study indicates that in Latin America lack of motivation is among the main reasons for abandoning physical exercise
The technological development of the last decades has allowed the incorporation of virtual reality into the healthcare field favoring user motivation Virtual reality is an experience based on the interactive digital simulation of environments and objects These systems are categorized as non-immersive semi-immersive and immersive Non-immersive systems use monitors or television screens semi-immersive systems use panoramic screens to enhance the immersive experience and immersive systems use head-mounted displays or multi-projected environments that generate a strong sense of immersion It has been posited that the cost and expertise required to operate immersive systems may hinder their widespread use in clinical settings In addition the immersive sensation could produce symptoms such as visual fatigue and dizziness cybersickness On the other hand non-immersive systems using commercially available home consoles are now considered an attractive and more accessible alternative to more sophisticated immersive systems
Unlike traditional video games that use a standard command or joystick active video games AVGs also called exergames use motion monitoring systems such as accelerometers gyroscopes haptic technology and video capture AVGs have been defined as a combination of video game technologies and exercise routines to motivate physical activity among individuals or groups recognizing that exercise in older people requires a greater understanding of the complexity of interaction with computer systems
Conventional physical rehabilitation CPR consists of traditional physical exercises that improve functional capacity Over the past few years it has been suggested that incorporating AVGs into CPR can optimize clinical and psychosocial outcomes in the elderly AVGs have been reported to promote improvements in functional mobility coordination muscle strength and cognitive function in older people In addition AVGs improve walking ability and postural balance as well as social well-being perception of loneliness social connectedness and positive attitudes However this research has focused on healthy elderly and patients with neurocognitive pathologies On the other hand little information is available on older people with musculoskeletal conditions such as OA In this regard a systematic review conducted in patients with knee andor hip OA indicates that the evidence is insufficient and inconclusive regarding the effectiveness of AVGs Moreover one study concludes that AVGs are a feasible and acceptable intervention for patients with knee OA Interestingly both studies raise the benefits and potential of AVGs in this population urging further clinical trials
Research question In older adults with knee andor hip OA Is AVG-guided physical exercise adjunct to CPR more effective than CPR alone in improving clinical and psychosocial outcomes
Working hypothesis In older adults with knee andor hip OA AVG-guided physical exercise adjunct to CPR is more effective than CPR alone in improving clinical and psychosocial outcomes
General objective To determine the effects of an AVG-guided physical exercise program adjunct to CPR on clinical and psychosocial outcomes in older adults with knee andor hip OA attended at a community-based family health center
Specific objectives
1 To characterize the study sample from sociodemographic anthropometric clinical and psychosocial perspectives
2 To compare the results of the primary outcome functional mobility and secondary outcomes between the study groups experimental and control in the different instances of outcome measurement
3 To evaluate the clinical significance of the interventions and the clinical relevance of the interventions as perceived by the participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None