Feasibility Study of an Individualized Exergame Training for Older Adults With Mobility Impairment and/or Urinary Incontinence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility assessed by recruitment rate
研究概览
简要总结
This study examines the feasibility of an individualized video game training (VITAAL Exergame) for older adults with mobility impairments and/or urinary incontinence. In addition, the effect of the newly developed training program on motor and cognitive functions is examined. This study is a national study. The development of the exergame was carried out at the Fraunhofer AICOS research center in Portugal and further studies are being conducted in international collaboration with the University of Montréal in Canada, KU Leuven in Belgium and ETH Zurich. The Exergame consists of a video game based training, which is performed with step movements. These movements are detected by two sensors on the feet. The video game should make the training fun and motivate to train. The training will include specific cognitive and physical functions. Special emphasis will be put on a continuous interaction and integration of motor and cognitive functions. An intact cognitive-motor interaction as well as balance and strength form the basis for all everyday performances, especially for safe and accident-free movement in older adults. In the Exergame VITAAL, balance is trained with step-based games. Strength, especially leg strength, is trained through Tai-Chi-like movements/exercises.
The pelvic floor training takes place using a vaginal probe that measures the contractions of the pelvic floor. The training games on the VITAAL Exergame have been adapted for this purpose and are controlled via the probe.
All participants receive an individually tailored training session that is optimally adapted to their needs based on the results of the pre-measurement. Participants with urinary incontinence also receive an integrated pelvic floor training. The study includes 32-52 seniors with mobility impairments and 8-28 older adults with urinary incontinence. Balance and strength, gait pattern, cognitive functions and pelvic floor specific functions will be measured before and after the training in order to detect any changes. The training should be carried out during 12 weeks, with a maximum of two weeks break/holidays. There are two measurement dates with all examinations, whereby one measurement date lasts approx. 1.5 hours. All study participants can continue their everyday life as usual.
详细描述
The VITAAL exergame is an individualized multicomponent exergame training based mostly on the prevention and slowing of physical and cognitive decline and its consequences. It mainly consists of three (four with UI) components; strength training, balance training, cognitive training and pelvic floor muscle training (PFMT) when suffering from UI. For strength training, Tai Chi-inspired movements are included which are a combination of classical strength exercises and Tai Chi movements. Since Tai Chi is mainly performed in a semi-squat posture it places a large load on the muscles of the lower extremities. For balance training, step-based training is included in the VITAAL exergame, as the execution of rapid and well directed steps has been shown to be effective in preventing falls. Both, Tai Chi-inspired exercises and step-based exercises, combined with challenging game tasks, provide a 'holistic' physical activity requiring motor functions, cognition and mental involvement. The PFMT is divided in two categories, isolated exercises of PFM (different contraction sequences) and dual task exercises, where PFM contractions are performed with or in combination with balance exercises. Moreover, Tai Chi-inspired training, step-based training and PFMT could be more motivating and joyful than standard exercises. Some cognitive training is already included in these training components as they represent simultaneous cognitive-motor interaction and require motor and cognitive functions. But specific attentional and executive functions are important for walking abilities and safe gait. Therefore, the VITAAL exergame explicitly targets on these neuropsychological functions (selective attention, divided attention, inhibition/interference control, mental flexibility, working memory). To maximize benefits for participants, the VITAAL exergame implements some basic general training principles; providing feedback, optimal load of task demands, progression of difficulty and high variability.
Intervention group MI:
The VITAAL exergame intervention for MI includes 36 training sessions with three sessions per week, each lasting around 45 minutes (30 minutes real training time) resulting in 12 weeks of training (two weeks of break/holiday allowed). The time frame and training intensity is based upon studies illustrating positive training effects in older adults performing exergame training. A training session includes an individually calculated amount of strength, cognitive-motor and balance training, which remains the same over the 12 week intervention period. Between the training sessions and exercises, rest intervals will be integrated to alleviate the acquisition of new skills. Participants are allowed to continue their usual daily business and activities during the study period. The training takes place at Physio SPArtos in Interlaken, Bern. They get well instructed on how to set up and use the system at the physio centre. The first two training sessions will be supervised one to one, after that someone will observe the training every 4 weeks to make adjustments and support the participants. The other training sessions will be done without supervision. However, there will be a physiotherapist available in case questions come up or help is needed. The compliance with the exergame training will be monitored using an attendance protocol filled in by participants.
Intervention group UI:
For the incontinent women in this study, the VITAAL exergame intervention will last over 12 weeks and consists of three parts 1) VITAAL exergame (2 sessions/week) lasting 45 minutes each (30 minutes real training time) at the physio centre, 2) PFM exercises according to a training booklet (3 sessions/week) lasting 10 minutes each at home and 3) education related to UI at home.. Between the training sessions and exercises, rest intervals will be integrated to alleviate the acquisition of new skills. Participants will be allowed to continue their usual daily business and activities during the study period. The training will take place at the physio centre SPArtos, Interlaken, Switzerland and their home. Women will get instructed on how to set up and use the system at the centre and how to do the PFM exercises at home. The VITAAL exergame training sessions will be supervised. Furthermore, every fourth week the additional weight for the strength training will be adjusted. However; the participants will be encouraged to use the system as independently as possible. The compliance with the exergame training will be monitored using an attendance protocol filled in by participants. For both groups, training compliance will be followed online by the investigators in the Web portal as each participant will have a personal login and training data will be stored in the internet-based back-end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both (MI & UI):
- •Aged 60+ years
- •Live independently, in a residency dwelling, or with care
- •Standing straight for minimal 10 minutes without aids
- •Visual acuity with correction sufficient to work on a TV screen
- •Signed informed consent
- •SPPB < 10 (only for the study group with MI)
- •diagnosed with mixed urinary incontinence (MUI) or urge urinary incontinence (UUI) according to the Questionnaire for Urinary Incontinence Diagnosis (QUID)
- •moderate symptoms of UI (have reported at least 3 episodes of involuntary urine loss per week during the preceding 3 months)
- •correct contraction of PFM must be possible
- •must be able to undergo a gynaecological examination
排除标准
- •Both (MI & UI):
- •Mobility impairments that don't allow to play the exergame
- •Heavy noticeable cognitive impairments according to Thomman et al.
- •Acute or unstable chronic diseases (e.g., recent cardiac infarction, uncontrolled high blood pressure or cardiovascular disease, uncontrolled diabetes)
- •Orthopedic or neurological diseases that inhibit exergame training
- •Rapidly progressive or terminal illness
- •Insufficient knowledge of German
- •Chronic respiratory disease
- •Condition or therapy that weakens the immune system
- •Serious obesity (BMI > 40kg/m2)
- •Untreated chronic constipation
- •Important pelvic organ prolapse
- •Physiotherapy treatment or surgery for UI or pelvic organ prolapse in the past year
- •Use of medications for UI or affecting skeletal muscles
- •Change in hormonal replacement therapy in the last six months
- •Having an active urinary or vaginal infection in the past three months
结局指标
主要结局
Feasibility assessed by recruitment rate
时间窗: The recruitment rate is assessed from the beginning of September until the last participant is included in the study for approximately 2.5 months.
The recruitment rate assesses the number of participants who were interested in participating in the study, the number of participants who signed informed consent and the number of participants who were eligible for the study.
Feasibility assessed by a safety survey
时间窗: The questionnaire is completed during follow-up measurements within two weeks after the intervention. The survey lasts 2 minutes.
The study participants will receive a survey form at the end of the intervention period regarding safety during the exercises.
Feasibility assessed by a safety protocol
时间窗: Safety is assessed during the 12 week intervention period.
A protocol will be kept of all serious adverse events related to the intervention regarding safety during the exercises.
Feasibility assessed by adherence rate
时间窗: The adherence rate is assessed during the 12 week intervention period.
The number of training sessions attended is recorded by the participants in an attendance protocol. The maximum number of training sessions during the 12-week intervention is 36 for the MI and UI groups.
Feasibility assessed by attrition rate
时间窗: The attrition rate is assessed during the 12 week intervention period.
The attrition rate is assessed by the number of participants lost during the trial. This will be recorded in an attrition protocol.
Feasibility is assessd by a survey regarding time management of the assessments
时间窗: The questions will be assessed after the pre- and post-measurements within two weeks before and after the intervention. The survey lasts 1 minute.
To investigate whether the time used for the assessments was appropriate to the study population one question will be asked about the time management of the assessments during the pre- and post-measurement and another about the time management of the assessments during the intervention. This makes it easier to assess whether the number of assessments during the study is feasible for a future study.
次要结局
- Changes in physical performance(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The SPPB lasts 5 minutes.)
- Changes in exercise capacity(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The 1-MSTST lasts 2 minutes.)
- Change in interference control(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The CWIT lasts 8 minutes.)
- Changes in cadence(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.)
- Changes in amount of urinary urgency (only measured in UI group)(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The USS lasts 1 minute.)
- Changes in gait speed(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.)
- Changes in step length(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.)
- Changes in swing width(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.)
- Changes in maximal gait speed(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.)
- Change in memory functions(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The Wechsler-Memory-Scale-Revised backwards lasts 3 minutes.)
- Changes in overall cognitive functions(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The MoCA lasts 5 minutes.)
- Changes in pelvic floor muscle (PFM) strength (only measured in UI group)(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The PFM strength assessments lasts 10 minutes.)
- Changes in minimal toe clearance(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.)
- Changes in stride time(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.)
- Change in mental flexibility(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The TMT lasts 5 minutes.)
- Changes in quality of life (only measured in UI group): ICIQ-UI(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The ICIQ-UI lasts 2 minutes.)
- Changes in pelvic floor muscle (PFM) endurance (only measured in UI group)(Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The PFM endurance assessments lasts 5 minutes.)
- Changes in incontinence episodes (only measured in UI group)(Assessment takes place over 1 week before and after the intervention. Pre- and post-measurement changes are calculated.)
研究者
Eling DeBruin
Prof. Dr.
Swiss Federal Institute of Technology