Clinical trial NCT04587895: Feasibility Study of an Individualized Exergame Training for Older Adults With MI and/or UI (VITAAL)
Official title: Feasibility Study of an Individualized Exergame Training for Older Adults With Mobility Impairment and/or Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Mobility Impairment
Older Adults
Keywords: exergame
healthy ageing
feasibility
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Control group MI:

Participants of the MI control group are instructed to do a non-individualized conventional training including 15 minutes walking exercise (in nature or on treadmill) and additional 15 minutes of strength, balance, and cognitive-motor exercises (at the therapy centre or at home). The exercises are based on recommendations from the "Beratungsstelle für Unfallverhütung" (bfu). The participants will receive a training booklet with the exercises. In total there are three different training programs which are divided according to their level of difficulty. Participants are instructed to start with the first level for four weeks and then go on to the next level for another 4 weeks. The control group training in this study includes 36 training session with three sessions per week, each lasting around 45 minutes resulting in 12 weeks of training (two weeks of break/holiday allowed). 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 first training sessions take place at Physio SPArtos in Interlaken, whereas the walking can be made outside or on a treadmill. The participants get well instructed on how to do the training at the centre or at home. There will always be a supervisor at the training centre to further help and support the participants with any questions and issues. Furthermore, participants will be called every 4 weeks, to ensure social contact similar to that in the intervention group. The training components will not be individually adapted for this group. Participants in this groups will report their trainings in an attendance protocol and their additional activity in an activity protocol. In addition they need to rate the exercise intensity on each session with Borg scale.

Control group UI:

The control group training will last over 12 weeks. The training sessions will be divided in three parts 1) 30 minutes of brisk walking (2 sessions/week, 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. The PFM training booklet will be based on two studies that showed a reduction of incontinence in older adults while performing group pelvic floor muscle training (PFMT) and mobility exercises. The PFMT program will consist of 4 PFM exercises and will be divided into three phases allowing for the gradual progression in treatment (from first to third month), with gradual increase in difficult exercises in terms of duration, repetition and position. Each phase will last four weeks. 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 first training sessions take place at the physio centre SPArtos, Interlaken, whereas the walking can be made outside or on a treadmill. The participants get well instructed on how to do the training at home. Furthermore, participants will be called every 4 weeks, to ensure social contact similar to that in the intervention group. The training components will not be individually adapted for this group. Participants in this group will report their trainings in an attendance protocol and their additional activity in an activity protocol. The compliance with the active control intervention will be monitored using an attendance protocol filled in by participants. Furthermore, 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.

Eligibility criteria: Inclusion Criteria:

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

Only MI:

- SPPB \< 10 (only for the study group with MI)

Only UI:

* female
* 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

Exclusion Criteria:

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
* Cancer
* Serious obesity (BMI \> 40kg/m2)

Only UI:

* 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

Primary outcomes:
measure: Feasibility assessed by recruitment rate
timeFrame: The recruitment rate is assessed from the beginning of September until the last participant is included in the study for approximately 2.5 months.
measure: Feasibility assessed by adherence rate
timeFrame: The adherence rate is assessed during the 12 week intervention period.
measure: Feasibility assessed by attrition rate
timeFrame: The attrition rate is assessed during the 12 week intervention period.
measure: Feasibility assessed by a safety survey
timeFrame: The questionnaire is completed during follow-up measurements within two weeks after the intervention. The survey lasts 2 minutes.
measure: Feasibility assessed by a safety protocol
timeFrame: Safety is assessed during the 12 week intervention period.
measure: Feasibility is assessd by a survey regarding time management of the assessments
timeFrame: The questions will be assessed after the pre- and post-measurements within two weeks before and after the intervention. The survey lasts 1 minute.
Secondary outcomes:
measure: Changes in gait speed
timeFrame: 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.
measure: Changes in step length
timeFrame: 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.
measure: Changes in minimal toe clearance
timeFrame: 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.
measure: Changes in cadence
timeFrame: 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.
measure: Changes in stride time
timeFrame: 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.
measure: Changes in swing width
timeFrame: 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.
measure: Changes in maximal gait speed
timeFrame: 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.
measure: Changes in physical performance
timeFrame: 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.
measure: Changes in exercise capacity
timeFrame: 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.
measure: Change in mental flexibility
timeFrame: 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.
measure: Change in interference control
timeFrame: 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.
measure: Change in memory functions
timeFrame: 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.
measure: Changes in overall cognitive functions
timeFrame: 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.
measure: Changes in amount of urinary urgency (only measured in UI group)
timeFrame: 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.
measure: Changes in incontinence episodes (only measured in UI group)
timeFrame: Assessment takes place over 1 week before and after the intervention. Pre- and post-measurement changes are calculated.
measure: Changes in quality of life (only measured in UI group): ICIQ-UI
timeFrame: 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.
measure: Changes in pelvic floor muscle (PFM) strength (only measured in UI group)
timeFrame: 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.
measure: Changes in pelvic floor muscle (PFM) endurance (only measured in UI group)
timeFrame: 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.
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Physio SPArtos
state: Interlaken
Study officials:
affiliation: ETH Zurich - Institute of Human Movement Sciences and Sport
name: Eling de Bruin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: