Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02333214
Study type Interventional
Source Universidade Cidade de Sao Paulo
Contact Monica R Perracini, Phd
Email mrperracini@unicid.br
Status Recruiting
Phase N/A
Start date October 2014
Completion date December 2018

See also
  Status Clinical Trial Phase
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Completed NCT00384709 - Geriatric Education and Its Effect on Certain Aspects of Hospital Care of Nursing Home Patients N/A
Completed NCT05447533 - Clostridioides Difficile and Frailty N/A
Completed NCT03722017 - Drug Reduction in Older Patients: The DROP Trial N/A
Enrolling by invitation NCT05411393 - Synergizing Home Health Rehabilitation Therapy N/A
Completed NCT03477097 - Frailty Prevention Through Improvement of Nutrition Physical Activity and Social Participation N/A
Not yet recruiting NCT00756535 - Exercise Training in a Geriatric Hospital Ward N/A
Completed NCT01829594 - Case Managers to Frail Older People a Randomized Controlled Trial N/A
Recruiting NCT04095338 - Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation N/A
Completed NCT02975089 - A Pilot Study Comparing Effects of Nutrients Supplements and Dietary Approach in Frailty Management N/A
Completed NCT01922167 - Resistance Exercise Training and Amino Acid Leucine Supplementation in Frail Elderly Women N/A
Completed NCT02591602 - Teleradiology Program for Frail Patients Living at Home or in Nursing-homes N/A
Completed NCT00105781 - Nurse Physical Activity Counseling in Primary Care N/A
Completed NCT05802537 - Home-Based Exergame Program for Community-Dwelling Older Adults N/A
Completed NCT03990415 - Stay Strong, Stay Healthy Outcomes in Older Adults N/A
Terminated NCT02766075 - A STEP for Patients Prior to Undergoing TAVR: A Pilot Study N/A
Completed NCT01607736 - Pilot Study of Virtual Gait Training in Older Adults N/A
Completed NCT00038155 - Rehabilitation for Older Adults From Acute Medical Conditions Phase 2
Completed NCT04885608 - PReGe in Outdoor Fitness Parks N/A
Recruiting NCT05352802 - Multimodal Prehabilitation To Improve The Clinical Outcomes Of Frail Elderly Patients With Gastric Cancer N/A