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Feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit Plus™ for frail elderly: study protocol for a feasibility trial

Abstract

Background

Frailty can be defined as a medical syndrome with multiple causes and contributors, characterized by diminished strength and endurance and reduced physiological function that increases the vulnerability to develop functional dependency and/or death. Studies have shown that the most commonly studied exercise protocol for frail older adults is the multimodal training. Interactive video games (IVGs) involve tasks in virtual environments that combine physical and cognitive demands in an attractive and challenging way. The aim of this study will be to evaluate the feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit PlusTM (NWFP) for frail older adults.

Methods/design

The study is a randomized controlled, parallel group, feasibility trial. Participants will be randomly assigned to the experimental group (EG) and control group (CG). The EG will participate in 14 training sessions, each lasting 50 min, twice a week. In each training session, the participants will play five games, with three attempts at each game. The first attempt will be performed with the assistance of a physical therapist to correct the movements and posture of the patients and subsequent attempts will be performed independently. Scores achieved in the games will be recorded. The participants will be evaluated by a blinded physical therapist at three moments: before and after intervention and 30 days after the end of the intervention (follow-up). We will assess the feasibility, acceptability, safety, and clinical outcomes (postural control, gait, cognition, quality of life, mood, and fear of falling).

Discussion

Due to the deficiencies in multiple systems, studies have shown that multimodal interventions including motor-cognitive stimulation can improve the mobility of frail elderly adults. IVGs, among them the NWFP, are considered as a multimodal motor-cognitive intervention that can potentially improve motor and cognitive functions in the frail elderly. However, there is still no evidence in the literature that proves the feasibility, safety, acceptability, and functional outcomes of this intervention in frail elderly individuals.

Trial registration

Brazilian Registry of Clinical Trials (RBR-823rst). World Health Organization Trial Registration Data Set (Additional file 1).

Peer Review reports

Background

Frailty can be defined as a medical syndrome with multiple causes and contributors, characterized by diminished strength and endurance and reduced physiological function that increases an individual’s vulnerability to develop increased dependency and/or death [1]. A recent systematic review [2], incorporating 31 studies of frailty in persons aged 65 years or older, found a prevalence of from 4.0 to 17.0% (mean 9.9%) of physical frailty, with a higher prevalence when psychosocial frailty was also included. Women (9.6%) were almost twice as likely as men (5.2%) to be frail [1]. The prevalence of frailty is markedly increased in persons older than 80 [1].

Frail older adults have a high risk of becoming dependent; however, with adequate intervention (mainly nutrition and physical exercise), frailty can be reversed to a robust state [3]. A systematic review [4] showed that the best strategy to reduce the number of falls, improve gait and balance, and increase muscle strength in frail elderly individuals is interventions based on combined exercises, such as resistance training, muscle strengthening, flexibility, balance and coordination training, and aerobic exercises.

New types of intervention have been proposed as complementary tools for rehabilitation of the elderly, among them interactive video games (IVGs) that can optimize motor learning and neural plasticity [5]. IVGs combine motor and cognitive tasks which are performed in a motivating and challenging virtual environment [6]. IVGs stimulate complex and dynamic movements that are similar to the movements required in daily life [5]. In addition, IVGs are inexpensive, fun, and can be used by patients who live in remote settings. Together, these factors can help to improve adhesion to and results of rehabilitation [6].

Among IVGs, Nintendo Wii Fit Plus® (NWFP) games have been considered as an inexpensive motor-cognitive intervention. The games are played using the Balance Board, a wireless platform that detects body oscillation through four sensors that identify the center of pressure of the player. A recent systematic review [7] investigated the effects of IVGs on balance of different populations, among them, elderly people. Twelve of the selected studies assessed the effects of the NWFP and showed that the NWFP was effective for improving balance [8,9,10].

We performed an extensive search in the PubMed, Web of Science, and PEDro databases and found only one pilot study [11] which compared the effectiveness of the NWFP to improve mobility of pre-frail elderly people. The participants were randomized to one of three groups: (1) control, (2) seated exercise (traditional senior fitness program), or (3) NWFP group (basic games and addition of weight vest with 2% of their body weight every 2 weeks). The training of groups 2 and 3 was performed for 45 min, three times a week, for 15 weeks. There was improvement in physical functional status in the seated exercise and NWFP group compared to the control group. Despite the positive effects of the NWFP group, there were some methodological issues in this pilot study such as the absence of blindness of the subjects, therapists, and evaluators and the absence of the intention-to-treat analysis, since there was a dropout of 12 participants during the study. Furthermore, this pilot study did not assess the feasibility, safety, or acceptability of the NWFP for pre-frail elderly people. Finally, the participants of the NWFP group performed their training using a weight vest. The addition of weight certainly interfered in the intensity of the intervention with the games. In fact, the weight addition makes it difficult to infer whether the improvement occurred due to training with the games or the resistance of the weight vest.

Despite evidence of the positive effects of IVGs on clinical outcomes of community dwelling elderly people [12,13,14,15,16,17,18,19,20], it is not clear whether IVGs are feasible, safe, and acceptable for frail elderly people. Furthermore, the effectiveness of IVGs on this population has not been established.

Objectives

The current study aims to evaluate the feasibility, safety, acceptability, and functional outcomes of playing NWFP in frail older adults.

Hypotheses

  1. 1.

    We speculate that the frail elderly adults will improve their performance in the games and increase their scores;

  2. 2.

    We hypothesize that the intervention based on the NWFP games will not cause any adverse events such as syncope, dizziness, vertigo, falls, or any other medical condition that requires hospitalization or leads to disability. A previous study [24] showed that elderly individuals with Parkinson’s disease presented good acceptability to training with the NWFP;

  3. 3.

    We expect that the NWFP games will be acceptable to frail elderly adults. Despite this population possibly not being familiar with this kind of technology, the NWFP games were developed for entertainment with attractive and motivating virtual environment and are easy to use. A previous study [12] showed that elderly adults demonstrated good acceptability to training with NWFP;

  4. 4.

    The training sessions with the NWFP will provide improvement in postural control, gait, quality of life, cognition, and mood.

Trial design

The study will be a randomized controlled, parallel group, feasibility trial. Participants will be randomly assigned 1:1 to NWFP training or usual care. Study assessments will be conducted before and after the intervention and 30 days after the end of the intervention (follow-up).

Methods

Study setting

All participants will be recruited from the Frailty Ambulatory Clinics at the Hospital of the Medical School, University of Sao Paulo, Brazil.

Eligibility criteria

Inclusion criteria

  • Pre-frail and frail older adults aged 60 years or older, diagnosed with frailty syndrome according to Fried’s criteria: slow walking speed, impaired grip strength, self-reports of declining activity levels, exhaustion, and unintended weight loss (pre-frail—presence of at least one deficit and frail—presence of at least three deficits) [21];

  • Capacity to maintain a standing position and walk independently;

  • Normal or corrected visual acuity evaluated by the Snellen Scale [22];

  • Good hearing acuity, clinically assessed by the whisper test [23] without previous experience with the NWFP;

  • Agreement to participate by signing the informed consent form.

Exclusion criteria

  • Participants presenting with clinical conditions that could preclude the performance of physical exercises in an orthostatic position, such as cardiovascular, orthopedic, or neurological conditions, and older adults unable to interact with the games.

Administration of assessments

The same-trained researcher will provide the patient with a free informed consent form, which also contains information on the possible benefits that the interventions may bring and possible risks and indemnities to patients, also emphasizing that the patient can withdraw from the research at any time without any contradictions. On the same day, the evaluator will clarify all doubts regarding the research project and inform the volunteers that all data resulting from the survey will be used for scientific purposes. The same-trained researcher, blinded to treatment allocation, will evaluate all participants at three timepoints: immediately pre and post interventions and 30 days after the end of the interventions (follow-up). Participants will be asked not to inform the evaluators about the kind of intervention they have received.

Intervention

Participants will be randomly assigned to the experimental group (EG) and control group (CG), with an allocation ratio of 1:1.

Participants in the EG will participate in 14 training sessions, lasting 50 min, with a frequency of twice a week. In each training session, the participants will play five games and will be allowed three attempts at each game. The first attempt will be performed with the help of a physical therapist to correct the movements and posture of the patients through manual steering and verbal controls, while the subsequent attempts will be performed independently for the analyses of motor learning. Scores achieved in the games will be recorded. The time required to exchange the game will be approximately 2 min, and the patients will sit in a chair during this period.

Participants in the CG will be guided through verbal instructions and an illustrative booklet of guidelines carried out according to the World Health Organization, Policy Department number 385, 2014. This booklet describes physical activity, its benefits and risks, and encourages the study participants to seek health units near their residence where free physical activities are offered.

Game selection and description

The games were selected based on their motor and cognitive demands. Table 1 shows the description of the games [24].

Table 1 Description of the games

Outcome measures

Feasibility, acceptability, and safety outcomes

Feasibility will be assessed by the participants’ performance in the games, measured by the score achieved. Increasing scores indicate that the participant is capable of not only playing but also improving his or her performance in the games. This is the main measure of game play that promotes motivation [24]. To determine the feasibility of the program, we will collect attendance records from each participant before and after training sessions. We will consider the exercise program to be feasible if we maintain > 50% attendance for all sessions and average > 80% attendance per session.

Acceptability will be assessed through a game satisfaction questionnaire [25]. The questionnaire consists of 18 questions, among them are participants’ perception of games (“What do you like about the games?”; “Which game do you like best?”; “Which game do you like least?”); more difficult games (“Which game did you find most difficult?”); easier games (“Which game did you find easiest?”); motivation (“Did you feel motivated to play the games?”); and discomfort during training (“Did you feel any discomfort playing the games?”).

Safety will be assessed by the proportion of participants who experienced intervention-related adverse events or any serious adverse event during the study period. An adverse event is defined as any untoward medical occurrence, such as convulsions, syncope, dizziness, vertigo, falls, or any other medical condition that requires hospitalization or leads to disability. The therapist will register the occurrence of any adverse events, and the participant’s blood pressure, oxygen pulse saturation, heart and respiratory rates, and self-perception of effort, measured by the BORG Scale [26], will be assessed before and after each training session. We will monitor the onset of any clinical conditions that could preclude the performance of physical exercises in an orthostatic position, such as cardiovascular, orthopedic, or neurological conditions.

Clinical outcomes

Clinical outcomes will be the following: (1) postural control, assessed by the Mini-Balance Evaluation Systems Test (Mini-BEST-Test) [27]; (2) gait, assessed by the Functional Gait Assessment (FGA) [28]; (3) cognition, assessed by the Montreal Cognitive Scale (MoCA) [29]; (4) quality of life, assessed by the Brazilian version of the Short Form 36 (SF-36) [30]; (5) mood, assessed by the Geriatric Depression Scale (GDS-15) [31]; and (6) fear of falling, assessed by the Falls Efficacy Scale (FES-I) [32].

Due to the absence of specific studies on minimal detectable change (MDC) in frailty, we will consider a change of 3.5 points in the Mini-BEST-Test [33] and 4.2 points in the FGA [34] as significant. The MDC of the other scales has not yet been established.

Participant timeline

Table 2 illustrates the process of enrolling participants in the study, the intervention, and timing of assessments.

Table 2 Schedule of enrolment, interventions, and assessments

Sample size

As this is a feasibility study, no formal sample size calculation was performed [35]. Instead, this study follows sample size recommendations for pilot randomized controlled trials [36] and aims to have at least 12 participants per group who provide full data. We aim to recruit 15 participants for each group (i.e., total sample size of 30) to compensate for a 20% dropout. This number of participants is deemed adequate to provide sufficient information on key feasibility issues such as recruitment and acceptability of the intervention.

Recruitment

Potentially eligible participants will be identified by the clinical care team of Frailty Ambulatory Clinics at the Hospital of the Medical School, University of Sao Paulo. This team will undertake the initial approach, explaining how the study will be conducted. If the participant is willing to participate, a suitably qualified person will then provide verbal and written information about the study.

Randomization

Participants will be randomly assigned to the EG and CG, with an allocation ratio of 1:1. Randomization schedule will be prepared from a computer-generated list of random numbers, by a researcher not involved in the trial. In order to guarantee the balance between the groups regarding the level of frailty, we will stratify pre-frail and frail participants in the randomization.

Blinding

Blinding of trial participants and the intervention facilitator is not possible. All outcomes will be assessed by a researcher blinded to group allocation. Participants will be asked not to disclose their allocation to the physical therapist who will participate in the assessments.

Data collection

The participants will be interviewed regarding sociodemographic characteristics (age, gender, educational level, marital status, and family income), health (number of Fried’s criteria, number of falls in the previous 12 months, number of chronic diseases, and number of medications currently in use), and clinical conditions (postural control and balance, gait, cognition, quality of life, mood, fear of falling, and incidence of falls).

Data management and monitoring

All electronic identifiable information will be held on a secure, password-protected database, accessible only to the research sponsor. Paper forms with identifiable information will be held in secure, locked filing cabinets within a restricted area. Participants will be identified by a code number only. Direct access to source data/documents will be required for trial-related monitoring by authorized personnel only. Personal data collected during the trial will be handled and stored in accordance with the 1998 Data Protection Act. All paper and electronic data will be retained for at least 5 years after completion of the trial.

Statistical analyses

A detailed analysis plan will be prepared before all the data has been collected. Analyses will be conducted in Dell™ Statistica (version 13.0) using the principles of intention-to-treat. Descriptive statistics will be used to characterize the groups at baseline and present the feasibility outcomes. Although determining differences in clinical outcomes between the two groups is not the primary purpose of this trial, comparisons will be undertaken to investigate the feasibility of studying these outcomes and calculate estimates for the likely effect sizes and 95% confidence intervals. The effect size will be calculated in order to determine whether change can be detected over time using these outcome measures and to determine the most appropriate primary outcome. The focus of the results will be on the estimates of the treatment effects rather than statistical significance, and as such, no hypothesis testing will be undertaken [37]. Differences between the two comparison groups will be presented in the form of an unadjusted mean difference for continuous outcomes with their associated 95% confidence intervals.

Adverse events

An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this intervention. Any adverse events will be reviewed by the study team, and likely causality will be assessed and reported on a form.

Auditing

We will institute a rigorous program of quality control. The research sponsor in conjunction with the trial coordinator will be responsible for ensuring adherence to the trial protocols at the trial sites. Quality assurance checks will be undertaken by the University of Sao Paulo to ensure integrity of randomization, study entry procedures, and data collection.

Protocol amendments

Any modifications to the protocol which may impact on the conduct of the study, potential benefits to the patient, or may affect patient safety, including changes in study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendments will be agreed upon by the Ethics Committee of the Medical School of the University of Sao Paulo, Brazil, and the Brazilian Registry of Clinical Trials prior to implementation and notified to the health authorities in accordance with local regulations.

Dissemination policies

The dissemination will be to inform a wide range of local, national, and international audiences about the results and conclusions. It must, however, be remembered as part of this strategy that the current project is preliminary work aimed at informing a subsequent definitive clinical trial. We aim to publish our research in journals that cover the relevant medical specialties and with preference for those that deposit publications in open access databases to increase free dissemination. In addition, we aim to present this research at appropriate national and international conferences.

Discussion

The current study is designed to evaluate the feasibility, safety, acceptability, and functional outcomes of playing NWFP for frail older adults. This feasibility study is in preparation for a main trial that will go ahead if all feasibility criteria and hypothesis are met.

Frailty affects functionality in different aspects, such as mobility, gait, balance, muscle strength, motor processing, cognition, nutrition, and physical activity [38]. Due to the deficiencies in multiple systems, studies have shown that multimodal interventions including motor-cognitive stimulation can improve the mobility of frail elderly adults [39]. IVGs, among them the NWFP, are considered as a multimodal motor-cognitive intervention that can potentially improve motor and cognitive functions in the frail elderly. The NWFP can promote physical activity and improve balance, mobility, gait speed, muscle strength, flexibility, and functional abilities in older adults [40]. However, there is still no evidence in the literature that proves the feasibility, safety, acceptability, and functional outcomes of this intervention in frail elderly adults. We speculate that due to the challenging stimulation to the postural control and cognitive systems, added to factors that can improve motor learning such as visual and auditory feedback and motivating environment, the NWFP will be feasible, safe, and acceptable and will promote clinical benefit in frail elderly adults.

Trial status

To date, we have recruited about 50% of the participants.

Abbreviations

CG:

Control group

EG:

Experimental group

FES-I:

Falls Efficacy Scale

FGA:

Functional Gait Assessment

GDS-15:

Geriatric Depression Scale

IVG:

Interactive video games

MDC:

Minimal detectable change

Mini-BEST-Test:

Mini-Balance Evaluation Systems Test

MoCA:

Montreal Cognitive Scale

NWFP:

Nintendo Wii Fit PlusTM

SF-36:

Brazilian version of the Short Form 36

SP:

Sao Paulo

References

  1. John E, Morley MB, et al. Frailty Consensus: a call to action. JAMDA. 2013;14:392–7.

    Google Scholar 

  2. Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am GeriatrSoc. 2012;60:1487–92.

    Article  Google Scholar 

  3. International Conference on Frailty and Sarcopenia Research 2015 (ICFSR2015). 23–25 April 2015, Revere Hotel, Boston, MA, USA. Available from: http://www.jfrailtyaging.com/.

  4. Cadore EL, Rodríguez-Mãnas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013;16(2):105–14.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Skjæret-Maroni N, et al. Exergaming in older adults: movement characteristics while playing stepping games. Front Psychol. 2016;7:964.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Ribas CG, et al. Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson’s disease: a pilot randomized controlled trial. Parkinsonism and Related Disorders. 2017;38:13–8.

    Article  PubMed  Google Scholar 

  7. Staiano AE, Flynn R. Therapeutic uses of active videogames: a systematic review. Games Health J. 2014;3(6):351–65.

    Article  PubMed  PubMed Central  Google Scholar 

  8. McGough R, Paterson K, Bradshaw EJ, et al. Improving lower limb weight distribution asymmetry during the squat using Nintendo Wii Balance Boards and real-time feedback. J Strength Cond Res. 2012;26:47–52.

    Article  PubMed  Google Scholar 

  9. Rendon AA, Lohman EB, Thorpe D, et al. The effect of virtual reality gaming on dynamic balance in older adults. Age Ageing. 2012;41:549–52.

    Article  PubMed  Google Scholar 

  10. Taylor MJ, Shawis T, Impson R, et al. Nintendo Wii as a training tool in falls prevention rehabilitation: case studies. J Am GeriatrSoc. 2012;60:1781–3.

    Article  Google Scholar 

  11. Daniel K. Wii-hab for pre-frail older adults. RehabilNurs. 2012;(37, 4):195–201.

  12. Bieryla KA, Dold NM. Feasibility of Wii Fit training to improve clinical measures of balance in older adults. Clin Interv Aging. 2013:775–81.

  13. Cho GH, Hwangbo G, Shin HS. The effects of virtual reality-based balance training on balance of the elderly. J Phys Ther Sci. 2014;26(4):615–7.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Franco JR, Jacobs K, Inzerillo C, Kluzik J. The effect of the Nintendo Wii Fit and exercise in improving balance and quality of life in community dwelling elders. Technol Health Care. 2012;20(2):95–115.

    PubMed  Google Scholar 

  15. Lee A, Biggan JR, Taylor W, Ray C. The effects of a nintendo wii exercise intervention. Activities, Adaptation & Aging Journal. 2014;38

  16. Nicholson VP, McKean M, Lowe J, Fawcett C, Burkett B. Six weeks of unsupervised Nintendo Wii Fit gaming is effective at improving balance in independent older adults. J Aging Phys Act. 2015;23(1):153–8. https://doi.org/10.1123/japa.2013-0148.

    Article  PubMed  Google Scholar 

  17. Park EC, Kim SG, Lee CW. The effects of virtual reality game exercise on balance and gait of the elderly. J Phys Ther Sci. 2015;27(4):1157–9.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Toulotte C, Toursel C, Olivier N. Wii Fit® training vs. adapted physical activities: which one is the most appropriate to improve the balance of independent senior subjects? a randomized controlled study. Clin Rehabil. 2012;26(9):827–35.

    Article  PubMed  Google Scholar 

  19. Karahan AY, Tok F, Taşkın H, Kuçuksaraç S, Başaran A, Yıldırım P. Effects of exergames on balance, functional mobility, and quality of life of geriatrics versus home exercise programme: randomized controlled study, 23. Cent Eur J Public Health. 2015;(Suppl):S14–8.

  20. Lee M, Son J, Kim J, Yoon B. Individualized feedback-based virtual reality exercise improves older women’s self-perceived health: a randomized controlled trial. Arch Gerontol Geriatr. 2015;61(2):154–60.

    Article  PubMed  Google Scholar 

  21. Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A BiolSciMedSci. 2004;59(3):M255–63.

    Article  Google Scholar 

  22. Zapparoli M, Klein F, Moreira H. Avaliação da acuidade visual Snellen. ArqBras Oftamol. 2009:183–788.

  23. Lachs MS, Feinstein AR, Cooney LM Jr, et al. A simple procedure for general screening for functional disability in elderly patients. Ann Intern Med. 1990;112:699–706.

    Article  CAS  PubMed  Google Scholar 

  24. Pompeu JE, Andrade G, Mendonça MS, Pompeu SMAA, Lange B. Safety, feasibility and effectiviness of balance and gait training using Nintendo Wii Fit Plus on unstable surface in patients with Parkinson’s disease: a pilot study. J Alzheimers Dis Parkinsonism. 2014;4:136.

    Google Scholar 

  25. Galna B et al. Retraining function in people with Parkinson’s disease using the Microsoft kinect: game design and pilot testing. J Neuroeng Rehabil2014; 11(1):1.

  26. Borneto AF. Comparação entre a escala modificada de Borg e a escala de Borg modificada análogo visual aplicadas em pacientes com dispnéia. Rev Bras Ciênc Mov. 1989;3(1):34–40.

    Google Scholar 

  27. Maia AC, et al. Cross-cultural adaptation and analysis of the psychometric properties of the Balance Evaluation Systems Test and Mini BESTest in the elderly and individuals with Parkinson’s disease: application of the Rasch model. Braz J Phys Ther. 2013;17(3):195–217.

    Article  PubMed  Google Scholar 

  28. Beninato M, Fernandes A, Plummer LS. Minimal clinically important difference of the Functional Gait Assessment in older adults. Phys Ther. 2014;94:1594–603.

    Article  PubMed  Google Scholar 

  29. Duro D, et al. Validation studies of the Portuguese experimental version of the Montreal Cognitive Assessment (MoCA): confirmatory factor analysis. J Neurol. 2010:728–34.

  30. Ciconelli RM, et al. Brazilian-Portuguese version of the SF-36. A reliable and valid quality of life outcome measure. Rev Bras Reumatol. 1999;39(3):143–50.

    Google Scholar 

  31. Almeida OP, Almeida SA. Confiabilidade da Versão Brasileira da Escala de Depressão Geriátrica (GDS) versão reduzida. Arq Neuropsiquiatr. 1999;57(1–8):421–6.

    Article  CAS  PubMed  Google Scholar 

  32. Yardley L, et al. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Aging. 2005;34:614–9.

    Article  Google Scholar 

  33. Godi M, Franchignoni F, et al. Comparison of reliability, validity and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. PhyTher. 2013;93(2):158–67.

    Google Scholar 

  34. Lin JH, Hsu MJ, et al. Psychometric comparisons of 3 functional ambulation measures for patients with stroke. Stroke. 2010;41(9):2021–5.

    Article  PubMed  Google Scholar 

  35. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;27:287–91.

    Article  Google Scholar 

  37. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.

    Article  PubMed  Google Scholar 

  38. Gobbers RJ, Luijkx KG, Wijnen-Sponselee MT, Schols JM. Toward a conceptual definition of frail community dwelling older people. Nurs Outlook. 2010;58:76–86.

    Article  Google Scholar 

  39. Bray NW, Smart RR, Jakobi JM, Jones GR. Exercise prescription to reverse frailty. Appl Physiol Nutr Metab. 2016;41(10):1112–6.

    Article  PubMed  Google Scholar 

  40. Chao YY, Scherer YK. Effects of using Nintendo Wii™ exergames in older adults. A review of the literature. J Aging Health. 2015 Apr;27(3):379–402.

    Article  PubMed  Google Scholar 

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Acknowledgements

We would like to thank all the professionals who will participate in this study: Douglas Ferdinando, Antonio França, and Catharia Schultz.

Funding

The study will be carried out with its own financing.

Availability of data and materials

Not applicable.

Author information

Authors and Affiliations

Authors

Contributions

GCVG, JMRB, MSS, LV, EV, and JEP are involved in the trial design discussion and study protocol development. SML is involved in the trial design and discussion. WJF is involved in the study protocol development. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Gisele Cristine Vieira Gomes.

Ethics declarations

Ethics approval and consent to participate

This study was approved by the Ethics Committee of the Medical School of the University of Sao Paulo, Brazil (1.150.930), C ertificado de Apresentação para Apreciação Ética: 46658315.5.000.0068; Free and Informed Consent Term (Additional file 2). This trial was registered in the Brazilian Registry of Clinical Trials (RBR-823rst) on 11 June 2016.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Additional files

Additional file 1:

World Health Organization Trial Registration Data Set. (DOCX 14 kb)

Additional file 2:

School of medicine of the University of Sao Paulo free and informed consent term. (DOCX 15 kb)

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Gomes, G.C.V., Bacha, J.M.R., do Socorro Simões, M. et al. Feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit Plus™ for frail elderly: study protocol for a feasibility trial. Pilot Feasibility Stud 3, 41 (2017). https://doi.org/10.1186/s40814-017-0184-1

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