Frail ElderlyNCT02333214
Effectiveness of a Program Using Video Games Associated With Conventional Physiotherapy in Physical Functioning in Frail Elderly Compared to Conventional Physiotherapy
A study testing Exergames and conventional physiotherapy and Conventional physiotherapy in people with Frail Elderly, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Exergames and conventional physiotherapy and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Unintentional weight loss of ≥ 5% or ≥ 4.5kg body weight in the previous year.
- Exhaustion assessed by self-reported fatigue, indicated by two questions of the Center for Epidemiological Studies - Depression: (a) I felt that everything I did was an effort; (b) I could not get going. . Subjects answering "2" or "3" to either of these questions are categorized as frail by the exhaustion criterion.
- Decreased grip strength (kg/force) in the dominant hand adjusted according to sex and body mass index (BMI). The cutoff for grip strength (Kg) criterion for men 2will be: BMI ≤ 24 grip strength ≤ 29; BMI 24,1 - 28 grip strength ≤ 30; BMI > 28 grip strength ≤ 32. The cutoff for grip strength (Kg) criterion for women will be 2: BMI ≤ 23 - grip strength ≤ 17; BMI 23,1 - 26 grip strength ≤ 17,3; BMI 26,1 - 29 grip strength ≤ 18; BMI > 29 grip strength ≤ 21.
- Low level of physical activity. Participants will meet the criterion for physical inactivity if, in the last two weeks they did not perform a planned physical activity at least twice a week lasting more than 30 minutes or, if they did not perform planned or unplanned walks lasting for more than 15 minutes at least twice a week or, if they had performed any moderate or vigorous housework activity (> 2,5 METS) such as: wash or mop the floor, vacuuming, washing windows or wash the car frequently at least 1x a week for 30 minutes.
- Slow walking speed. The time to walk a 4.6 meters path, with two meters for acceleration and two for deceleration, will be measured The velocity for each participant will be recorded. Those with a gait speed equal or less than 0.8 m/s will be considered frail.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Monica R Perracini, Phd contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Cidade de São Paulo
São Paulo, 08371-110
Monica R Parracini, Phd
About this study
Official title: The Effectiveness of an Exercise Program Using Video Games Associated With Conventional Physiotherapy in Physical Functioning in Frail Elderly Compared to Conventional Physiotherapy: Randomized Clinical Trial
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.
Read the detailed 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.
- Conditions
- Frail Elderly
- Being tested
- Exergames and conventional physiotherapy, Conventional physiotherapy
- Keywords
- Virtual Reality Therapy, Video Game, Physical Exercise, Aged, Frailty
- Medical subject headings
- Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergames and conventional physiotherapyOther
Also called 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 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.
Conventional physiotherapyOther
Also called Control 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.
| Study group | Role | What they receive |
|---|---|---|
| Exergame + conventional physiotherapy | Experimental | 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. Receives: Other: Exergames and conventional physiotherapy |
| Conventional physiotherapy | Active comparator | 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. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: baseline, immediately after the intervention (12 weeks) and at 6 months
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: baseline, immediately after the intervention (12 weeks) and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Rodrigues Perracini, Universidade Cidade de Sao Paulo
- Investigators
- Monica R Perracini, Phd, Principal investigator, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333214
- Sponsor's protocol ID
- CAAE: 31998714.4.0000.0064
- Status last verified
- Nov 2017
- First submitted
- 22 Dec 2014
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Abellan van Kan G, Rolland Y, Houles M, Gillette-Guyonnet S, Soto M, Vellas B. The assessment of frailty in older adults. Clin Geriatr Med. 2010 May;26(2):275-86. doi: 10.1016/j.cger.2010.02.002.
PubMed 20497846Malmstrom TK, Miller DK, Morley JE. A comparison of four frailty models. J Am Geriatr Soc. 2014 Apr;62(4):721-6. doi: 10.1111/jgs.12735. Epub 2014 Mar 17.
PubMed 24635726Rockwood K, Andrew M, Mitnitski A. A comparison of two approaches to measuring frailty in elderly people. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):738-43. doi: 10.1093/gerona/62.7.738.
PubMed 17634321Bergman H, Ferrucci L, Guralnik J, Hogan DB, Hummel S, Karunananthan S, Wolfson C. Frailty: an emerging research and clinical paradigm--issues and controversies. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):731-7. doi: 10.1093/gerona/62.7.731.
PubMed 17634320Studenski S, Hayes RP, Leibowitz RQ, Bode R, Lavery L, Walston J, Duncan P, Perera S. Clinical Global Impression of Change in Physical Frailty: development of a measure based on clinical judgment. J Am Geriatr Soc. 2004 Sep;52(9):1560-6. doi: 10.1111/j.1532-5415.2004.52423.x.
PubMed 15341562Abate M, Di Iorio A, Di Renzo D, Paganelli R, Saggini R, Abate G. Frailty in the elderly: the physical dimension. Eura Medicophys. 2007 Sep;43(3):407-15. Epub 2006 Nov 22.
PubMed 17117147Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27.
PubMed 24291597de Bruin ED, Schoene D, Pichierri G, Smith ST. Use of virtual reality technique for the training of motor control in the elderly. Some theoretical considerations. Z Gerontol Geriatr. 2010 Aug;43(4):229-34. doi: 10.1007/s00391-010-0124-7.
PubMed 20814798Levin MF. Can virtual reality offer enriched environments for rehabilitation? Expert Rev Neurother. 2011 Feb;11(2):153-5. doi: 10.1586/ern.10.201. No abstract available.
PubMed 21306202Bisson E, Contant B, Sveistrup H, Lajoie Y. Functional balance and dual-task reaction times in older adults are improved by virtual reality and biofeedback training. Cyberpsychol Behav. 2007 Feb;10(1):16-23. doi: 10.1089/cpb.2006.9997.
PubMed 17305444Maillot P, Perrot A, Hartley A. Effects of interactive physical-activity video-game training on physical and cognitive function in older adults. Psychol Aging. 2012 Sep;27(3):589-600. doi: 10.1037/a0026268. Epub 2011 Nov 28.
PubMed 22122605Jorgensen MG, Laessoe U, Hendriksen C, Nielsen OB, Aagaard P. Efficacy of Nintendo Wii training on mechanical leg muscle function and postural balance in community-dwelling older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2013 Jul;68(7):845-52. doi: 10.1093/gerona/gls222. Epub 2012 Oct 31.
PubMed 23114461Bieryla KA, Dold NM. Feasibility of Wii Fit training to improve clinical measures of balance in older adults. Clin Interv Aging. 2013;8:775-81. doi: 10.2147/CIA.S46164. Epub 2013 Jun 24.
PubMed 23836967Pluchino A, Lee SY, Asfour S, Roos BA, Signorile JF. Pilot study comparing changes in postural control after training using a video game balance board program and 2 standard activity-based balance intervention programs. Arch Phys Med Rehabil. 2012 Jul;93(7):1138-46. doi: 10.1016/j.apmr.2012.01.023. Epub 2012 Mar 11.
PubMed 22414490
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Exercise Program Using Video Games Associated With Conventional Physiotherapy in Physical Functioning in Frail Elderly Compared to Conventional Physiotherapy: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02333214
- Acronym / sponsor ID
- CAAE: 31998714.4.0000.0064
- Conditions
- Frail Elderly
- Keywords
- Virtual Reality Therapy, Video Game, Physical Exercise, Aged, Frailty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergame + conventional physiotherapy | Experimental | Other: Exergames and conventional physiotherapyThis 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. |
| Conventional physiotherapy | Active comparator | Other: Conventional physiotherapyThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Unintentional weight loss of ≥ 5% or ≥ 4.5kg body weight in the previous year.
- Exhaustion assessed by self-reported fatigue, indicated by two questions of the Center for Epidemiological Studies - Depression: (a) I felt that everything I did was an effort; (b) I could not get going. . Subjects answering "2" or "3" to either of these questions are categorized as frail by the exhaustion criterion.
- Decreased grip strength (kg/force) in the dominant hand adjusted according to sex and body mass index (BMI). The cutoff for grip strength (Kg) criterion for men 2will be: BMI ≤ 24 grip strength ≤ 29; BMI 24,1 - 28 grip strength ≤ 30; BMI > 28 grip strength ≤ 32. The cutoff for grip strength (Kg) criterion for women will be 2: BMI ≤ 23 - grip strength ≤ 17; BMI 23,1 - 26 grip strength ≤ 17,3; BMI 26,1 - 29 grip strength ≤ 18; BMI > 29 grip strength ≤ 21.
- Low level of physical activity. Participants will meet the criterion for physical inactivity if, in the last two weeks they did not perform a planned physical activity at least twice a week lasting more than 30 minutes or, if they did not perform planned or unplanned walks lasting for more than 15 minutes at least twice a week or, if they had performed any moderate or vigorous housework activity (> 2,5 METS) such as: wash or mop the floor, vacuuming, washing windows or wash the car frequently at least 1x a week for 30 minutes.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exergames and conventional physiotherapyAlso: Experimental GroupThe 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. | Other | Exergame + conventional physiotherapy |
| Conventional physiotherapyAlso: Control GroupThe 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. | Other | Conventional physiotherapy |
Primary outcome
Change in the Short Physical Performance Battery
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
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).
Change in the Usual walking speed test
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
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.
Change in the Four Step Square Test
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
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.
3 secondary outcomes
Change in the The timed 5-step test
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Change in the Falls Efficacy Scale International (FES-I Brasil)
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Change in the Dual task walking speed
Time frame: baseline, immediately after the intervention (12 weeks) and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 20497846Abellan van Kan G, Rolland Y, Houles M, Gillette-Guyonnet S, Soto M, Vellas B. The assessment of frailty in older adults. Clin Geriatr Med. 2010 May;26(2):275-86. doi: 10.1016/j.cger.2010.02.002.
- Background: PubMed 24635726Malmstrom TK, Miller DK, Morley JE. A comparison of four frailty models. J Am Geriatr Soc. 2014 Apr;62(4):721-6. doi: 10.1111/jgs.12735. Epub 2014 Mar 17.
- Background: PubMed 17634321Rockwood K, Andrew M, Mitnitski A. A comparison of two approaches to measuring frailty in elderly people. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):738-43. doi: 10.1093/gerona/62.7.738.
- Background: PubMed 17634320Bergman H, Ferrucci L, Guralnik J, Hogan DB, Hummel S, Karunananthan S, Wolfson C. Frailty: an emerging research and clinical paradigm--issues and controversies. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):731-7. doi: 10.1093/gerona/62.7.731.
- Background: PubMed 15341562Studenski S, Hayes RP, Leibowitz RQ, Bode R, Lavery L, Walston J, Duncan P, Perera S. Clinical Global Impression of Change in Physical Frailty: development of a measure based on clinical judgment. J Am Geriatr Soc. 2004 Sep;52(9):1560-6. doi: 10.1111/j.1532-5415.2004.52423.x.
- Background: PubMed 17117147Abate M, Di Iorio A, Di Renzo D, Paganelli R, Saggini R, Abate G. Frailty in the elderly: the physical dimension. Eura Medicophys. 2007 Sep;43(3):407-15. Epub 2006 Nov 22.
- Background: PubMed 24291597Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27.
- Background: PubMed 20814798de Bruin ED, Schoene D, Pichierri G, Smith ST. Use of virtual reality technique for the training of motor control in the elderly. Some theoretical considerations. Z Gerontol Geriatr. 2010 Aug;43(4):229-34. doi: 10.1007/s00391-010-0124-7.
- Background: PubMed 21306202Levin MF. Can virtual reality offer enriched environments for rehabilitation? Expert Rev Neurother. 2011 Feb;11(2):153-5. doi: 10.1586/ern.10.201. No abstract available.
- Background: PubMed 17305444Bisson E, Contant B, Sveistrup H, Lajoie Y. Functional balance and dual-task reaction times in older adults are improved by virtual reality and biofeedback training. Cyberpsychol Behav. 2007 Feb;10(1):16-23. doi: 10.1089/cpb.2006.9997.
- Background: PubMed 22122605Maillot P, Perrot A, Hartley A. Effects of interactive physical-activity video-game training on physical and cognitive function in older adults. Psychol Aging. 2012 Sep;27(3):589-600. doi: 10.1037/a0026268. Epub 2011 Nov 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica R Perracini, Phd contact
Monica R Perracini, Phd principal investigator
Universidade Cidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergames and conventional physiotherapy and Conventional physiotherapy in people with Frail Elderly, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica R Perracini, Phd (mrperracini@unicid.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Short Physical Performance Battery (time frame: baseline, immediately after the intervention (12 weeks) and at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333214, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.