Clinical trial NCT02077049: Are Serious Games Promoting Mobility an Attractive Alternative to Conventional Self-training for Elderly People?
Official title: Are Serious Games Promoting Mobility an Attractive Alternative to Conventional Self-training for Elderly People? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitations
Geriatric Disorder
Keywords: elderly
exercise program
self-training
mobility
computer-based learning games
serious game
balance
training adherence
training compliance
Kinect ®
Fit Bit ®
Lead sponsor: Klinik Valens
Sponsor class: OTHER
Collaborators: name: State Secretariat for Education Research and Innovation, Switzerland
name: Office Ambient Assisted Living
First posted: 2014-03-04
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to determine whether elderly people in rehabilitation setting show higher adherence to self-training when using computer-based-learning games (i.e. the so called serious games) than when performing conventional exercises. Secondly the study explores to which extend balance and mobility performances vary according to the mode of self-training.

The primary study hypothesis is that elderly people practice longer and more frequently with serious games than with a conventional exercise booklet. The secondary hypothesis is that patients experience a significant higher improvement in their balance capacity by using serious games compared to patients performing conventional exercises.

Detailed description: Background:

The Swiss population, and in Europe in general, is getting older. Due to this evolving demographic trend, the need to develop specific healthcare services for this age group is becoming crucial. From the international literature, evidence-based findings have demonstrated that physical abilities of elderly people can be increased, and institutional placement and mortality can be reduced through specific inpatient rehabilitation programs (Bachmann, Finger et al. 2010).

Adults 65 years and older should carry out aerobic physical activities for at least 150 minutes of moderate intensity or for 75 minutes of high intensity in a week. Besides it is strongly recommended that senior adults perform strengthening exercises minimum twice a week and activities promoting balance minimum thrice a week (WHO 2010; NIH 2013).

In order to increase the training intensity and thus the independence in activities of daily living, older patients admitted in Kliniken Valens are instructed with a customized self-training program, in addition to the usual rehabilitation services. As for therapist-assisted sessions, this self-training program leads to significant improvement of patient's physical performance (Olney, Nymark et al. 2006) and represents therefore a proven, efficient and cost-effective intervention for inpatient settings. However, the compliance of elderly people to execute self-training exercises varies considerably. These programs are often considered as tedious and boring, and so prematurely stopped (Phillips, Schneider et al. 2004). An alternative to increase patient's motivation could be through serious games practice. Kliniken Valens has already experienced promising results with computer-based games such as the Nintendo Wii® (Schnurr and Oesch 2012).

Methods:

In this study participants are categorized in 4 strata according to their Berg Balance Score (BBS) (≤ 44 or ≥45) and their computer skills. Subsequently they are allocated randomly either in the intervention group or in the control group. In addition to the usual rehabilitation services provided in the clinic, participants of both groups are entitled to 2 additional time-slots (2 x 30 min/day) devoted to self-training and this during the 10 days of the intervention period. This protocol ensures the same conditions for each participant to perform or not self-training exercises. For safety measures, participants with a low BBS (\<45) perform the program in siting, whereas those with a higher BBS (≥45) practice in standing position (in front of a bench). The time frame of the intervention phase (from t1 to t2) lasts 10 working days and starts after self-training exercises have been instructed. In other words, t1 equates to approximately day 4 after the patient's admission in the clinic and t2 is 10 working days later, i.e. approximately day 16 after admission.

Intervention group:

The participants are instructed by experienced physiotherapists on serious games with Kinect®. Additionally, participants wear the Fit Bit® (an activity tracker device) and are encouraged to walk and climb stairs instead of using the escalator. Finally participants are asked to write down in a logbook, the frequency and duration of their self-training sessions.

Control group:

As in the usual rehabilitation services, experienced physiotherapists arrange a customized self-training program, instruct the exercises and deliver a hand-out. Additionally, patients are encouraged to walk and climb stairs instead of using the escalator. Finally participants are asked to write down in a logbook, the frequency and duration of their self-training sessions.

Data collection:

Data on self-training's intensity (primary outcome) are extracted from the logbook at post-intervention (t2) i.e. after the 10 working days of the intervention phase. The Berg Balance Scale and the Falls Efficacy Scale (secondary outcomes) are completed by a blinded researcher at pre- and post-intervention (before t1 and after t2) i.e. approximately at day 1-2 after admission and day 16-17 after admission.

Data analysis:

Data are analyzed using the statistical software for social sciences (SPSS). The statistical analysis of the two groups is performed following a normal distribution of data, with an unmatched t-test. For non-normal distributions, the Mann-Whitney U test is used.

Eligibility criteria: Inclusion Criteria:

1. +65 years old
2. Ability to walk independently over 20meters, with or without walking aids.
3. Self-training prescribed by the doctor
4. sufficient written and spoken knowledge of German to fill out questionnaires, with or without help.
5. Informed consent

Exclusion Criteria:

1. Cognitive impairment, defined as a Mini-Mental-State Examination (MMSE) score \< 26.
2. Other limiting disorders hampering the practice of computer-based games (e.g. visual impairment, numbness, vertigo)

Primary outcomes:
measure: Intensity of self-training
timeFrame: The intensity of self-training is recorded every day and thus from the begining (t1) till the end (t2) of the intervention phase ie. during 10 working days.
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days
measure: Falls Efficacy Scale - International version
timeFrame: The questionnaire is completed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days
measure: Local dynamic stability
timeFrame: The test is performed at the before the start of the intervention (t1) and again at after the end of the intervention (t2) i.e. after 10 working days.
Other outcomes:
Locations:
city: Walenstadtberg
country: Switzerland
facility: Walenstadtberg Klinik
state: Saint Gallen
Study officials:
affiliation: Kliniken Valens
name: Peter Oesch, PhD PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnurr B, & Oesch P. Sind Nintendo Wii-Balancespiele eine machbare Alternative zum herkömmlichen Selbsttraining des Gleichgewichts nach Schlaganfall? Ergoscience (4): 147-156, 2012.
citation: Bachmann S, Finger C, Huss A, Egger M, Stuck AE, Clough-Gorr KM. Inpatient rehabilitation specifically designed for geriatric patients: systematic review and meta-analysis of randomised controlled trials. BMJ. 2010 Apr 20;340:c1718. doi: 10.1136/bmj.c1718.
citation: Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
citation: Phillips EM, Schneider JC, Mercer GR. Motivating elders to initiate and maintain exercise. Arch Phys Med Rehabil. 2004 Jul;85(7 Suppl 3):S52-7; quiz S58-9. doi: 10.1016/j.apmr.2004.03.012.
citation: Olney SJ, Nymark J, Brouwer B, Culham E, Day A, Heard J, Henderson M, Parvataneni K. A randomized controlled trial of supervised versus unsupervised exercise programs for ambulatory stroke survivors. Stroke. 2006 Feb;37(2):476-81. doi: 10.1161/01.STR.0000199061.85897.b7. Epub 2006 Jan 12.
citation: Oesch P, Kool J, Fernandez-Luque L, Brox E, Evertsen G, Civit A, Hilfiker R, Bachmann S. Exergames versus self-regulated exercises with instruction leaflets to improve adherence during geriatric rehabilitation: a randomized controlled trial. BMC Geriatr. 2017 Mar 23;17(1):77. doi: 10.1186/s12877-017-0467-7.
citation: Hasselmann V, Oesch P, Fernandez-Luque L, Bachmann S. Are exergames promoting mobility an attractive alternative to conventional self-regulated exercises for elderly people in a rehabilitation setting? Study protocol of a randomized controlled trial. BMC Geriatr. 2015 Sep 7;15:108. doi: 10.1186/s12877-015-0106-0.