An interventional study of Exergames and conventional physiotherapy and Conventional physiotherapy in Frail Elderly, sponsored by Universidade Cidade de Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-11-28.
Sponsored by Universidade Cidade de Sao Paulo · Not applicable, Interventional, and Treatment
Frailty is a highly prevalent condition, reaching approximately 7% to 30% of older adults aged from 65 up to 80 years [2]. Although exercises seemed to be beneficial for the frail elders, there is still insufficient evidence to indicate the appropriate modality, frequency and intensity of physical exercises that were able to improve physical functioning in this population [9]. The virtual reality (VR) using interactive games (exergames) have generated broad scientific and clinical interest in recent years[10]. Studies indicate that older adults can benefit from training with exergames in improving mobility [12, 13], lower limb strength [14], cognition, particularly executive function [13], body balance [10, 15-18], reaction time [12] and may contribute indirectly to prevent falls [10, 19, 20]. But, there is still insufficient evidence to suggest that the use of exergames are superior even to other types of intervention [21-23] or in combination with conventional physiotherapy [24] The purpose of this study is to investigate the effectiveness of adding exercises using interactive videogames (exergames) in improving physical functioning on frail and pre frail older people when compared to conventional physiotherapy. A parallel randomized clinical with a 6 month follow-up period will be conducted with 82 frail community dwelling older adults. Participants randomized to the Experimental Group will be submitted to 30 minutes of conventional physiotherapy and 20 minutes of therapy using interactive games Xbox 360 Video Game and Entertainment Microsoft System with Kinect sensor.
The Control Group will receive 50 minutes of conventional physiotherapy. Both groups will receive 50 minutes of intervention twice a week for 12 weeks. Primary outcomes will be assessed by the Short Physical Performance Battery, the Usual walking speed test and Four Step Square Test in the baseline, 3 and 6 months after that.
Frailty is considered a biological geriatric syndrome, characterized by a decreased resistance to stresses and functional reserve due to the cumulative decline in multiple physiological systems, with consequent increased state of vulnerability [2]. Negative health related outcomes, such as disability, recurrent hospitalization, institutionalization, falls and mortality [2-4] are associated with frailty, considered an emerging public health problem [2, 5]. Physical exercise has been recommended as an intervention strategy for the prevention and rehabilitation of the mobility-related outcome in the frail elderly whit positive impact on functional capacity and performance [8].
A functional downward spiral characterized by an impairment of several functional domains, such as strength, muscular endurance and motor-cognitive processes, ultimately leading to restricted mobility and decreased physical activity level is commonly observed in frail older people. Interventions that promote the integration of multisensory, cognitive and motor skills can be able to motivate the older people to remain more active for longer periods, despite their limitations. Exergames involve tasks in virtual environments that combine physical and cognitive demands in an attractive and challenging way. The player is encouraged to achieve goals and overcome limits during the game, providing immediate feedback in relation to their performance. The game experience can create a greater sense of self-efficacy and generate a more positive perception of personal skills, modulated by a positive environment reinforcement, consequently increasing motivation and engagement. This combination of greater sense of self-efficacy and greater motivation could provide a positive and necessary influence for most older people to overcome their limitations and create new lifestyle habits [25], decreasing disability. This study sought to investigate the effectiveness of adding exercises using interactive videogames (exergames) in improving physical functioning on frail and pre frail older people when compared to conventional physiotherapy.
Universidade Cidade de Sao Paulo is the lead sponsor of 40 studies on the registry; 1 is open to participants now.
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Community dwelling older adults without severe cognitive impairment (defined as a Mini Mental State Examination (MMSE) score adjusted according to the educational level with reference cutoff scores of: 13 points for those who are illiterate, ; 18 points for those with elementary and middle levels, and 26 points for those who have a high level 26), without any physiotherapy intervention for at least three months and classified as frail or pre-frail, according to the phenotype of frailty using Fried et al. criteria:
Exclusion Criteria:
Severe visual impairment that prevents interaction with video games, if they had a localized loss of muscle strength and/or changes in postural tone that impede the execution of safe displacement movements in the standing position, without the aid of another person and, if they present chronic or acute diseases that contra-indicate therapeutic exercises.
This group will be submitted to 30 minutes of conventional physiotherapy and 20 minutes of therapy using interactive games Xbox 360 Video Game and Entertainment Microsoft System with Kinect sensor, intervention twice a week for 12 weeks. Each game has three difficulty levels that can be used according to the performance of each participant. The protocol of conventional physiotherapy will be customized and will include exercises to improve strength and muscle power, flexibility, mobility, balance, and aerobic conditioning exercises. In particular cases, when necessary analgesia will be used to relive pain.
Other: Exergames and conventional physiotherapy
The control group will receive 50 minutes of conventional physiotherapy intervention twice a week for 12 weeks. The protocol of conventional physiotherapy will be customized and will include exercises to improve strength and muscle power, flexibility, mobility, balance, and aerobic conditioning exercises. In particular cases, when necessary analgesia will be used to relive pain.
Other: Conventional physiotherapy
The protocol of conventional physiotherapy will be customized and will include exercises to improve strength and muscle power, flexibility, mobility, balance, and aerobic conditioning exercises. In particular cases, when necessary analgesia will be used to relive pain. The progression of the exercises will be individualized according to the treatment plan established in the initial functional assessment and will be target to meet patient's improvement during treatment. Conventional physiotherapy will be conducted in pairs. In this group exercises that are best accomplished using virtual scenarios, such as dual task exercises, anticipatory adjustments exercises and inter limb coordination exercises will be performed using video games.
Also known as: Experimental Group
The protocol of conventional physiotherapy will be customized and will include exercises to improve strength and muscle power, flexibility, mobility, balance, and aerobic conditioning exercises. In particular cases, when necessary analgesia will be used to relive pain. The progression of the exercises will be individualized according to the treatment plan established in the initial functional assessment and will be target to meet patient's improvement during treatment. Conventional physiotherapy will be conducted in pairs. In this group dual task exercises, anticipatory adjustments exercises and inter limb coordination exercises will be performed without the virtual environment.
Also known as: Control Group
Change in the Short Physical Performance Battery
Three batteries of tests covering dimensions: balance, usual walking speed and sit-to-stand test, with scores ranging from zero (worst performance) to 12 points (best performance).
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Change in the Usual walking speed test
The test will be conducted on a flat surface with 8.6 meters free marked by black tape at intervals of two meters, 4,6 meters and two meters and the participant will be instructed to walk at their usual pace using their usual footwear.
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Change in the Four Step Square Test
Assessment of participants balance and their ability to carry out changes in the direction of the step forward, backward, and sideways, surpassing a low obstacle.
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Change in the The timed 5-step test
Assessment of participants dynamic balance. During the test the participant will step forward and up and backward and down from a 10.1 cm step five times as fast as possible
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Change in the Falls Efficacy Scale International (FES-I Brasil)
The scale consists of 16 items that describe the activities of daily life and the participants should answer the level of concern of falling during these activities.
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Change in the Dual task walking speed
To assess the attentional demand during walking, we will use the test of usual walking speed in a 4.6 meters path with dual task. The participant will be asked to tell the evaluator an important fact of their past (the happiest day of his life, for example) along the way while walking.
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
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Universidade Cidade de Sao Paulo