Urinary IncontinenceNCT04587895
Feasibility Study of an Individualized Exergame Training for Older Adults With MI and/or UI (VITAAL)
A study testing VITAAL Exergame, Conventional Training UI and Conventional Training MI in people with Urinary Incontinence and Mobility Impairment, run by Eling DeBruin at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Urinary Incontinence, Mobility Impairment, Older Adults
- What is being tested?
- VITAAL Exergame, Conventional Training UI and Conventional Training MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Oct 2020to Oct 2021
- 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
- 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
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- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Physio SPArtos
Bern, Interlaken, 3800
Jacqueline de Jong, MSc, +41338288868, j.dejong@artos.ch
Melanie Thalmann, MSc, +41446330852, melanie.thalmann@hest.ethz.ch
About this study
Official title: Feasibility Study of an Individualized Exergame Training for Older Adults With Mobility Impairment and/or Urinary Incontinence
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.
Read the 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.
- Conditions
- Urinary Incontinence, Mobility Impairment, Older Adults
- Being tested
- VITAAL Exergame, Conventional Training UI, Conventional Training MI
- Keywords
- exergame, healthy ageing, feasibility
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITAAL ExergameBehavioural
12 weeks training with the VITAAL Exergame. 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.
Conventional Training UIBehavioural
12 weeks non-individualized conventional training with a training booklet and additional walking exercise. The PFM training booklet is based on exercises that showed a reduction of incontinence in older adults while performing group pelvic floor muscle training (PFMT) and mobility exercises.
Conventional Training MIBehavioural
12 weeks non-individualized conventional training with a training booklet and additional walking exercise. The exercises are based on recommendations from the "Beratungsstelle für Unfallverhütung" (bfu).
| Study group | Role | What they receive |
|---|---|---|
| MI Intervention | Experimental | 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). 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. Receives: Behavioral: VITAAL Exergame |
| MI Control | Active comparator | 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). Receives: Behavioral: Conventional Training MI |
| UI Intervention | Experimental | 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. Receives: Behavioral: VITAAL Exergame |
| UI Control | Active comparator | 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. Receives: Behavioral: Conventional Training UI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by recruitment rate
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.
Measured: The recruitment rate is assessed from the beginning of September until the last participant is included in the study for approximately 2.5 months.
Feasibility assessed by adherence rate
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.
Measured: The adherence rate is assessed during the 12 week intervention period.
Feasibility assessed by attrition rate
The attrition rate is assessed by the number of participants lost during the trial. This will be recorded in an attrition protocol.
Measured: The attrition rate is assessed during the 12 week intervention period.
Feasibility assessed by a safety survey
The study participants will receive a survey form at the end of the intervention period regarding safety during the exercises.
Measured: The questionnaire is completed during follow-up measurements within two weeks after the intervention. The survey lasts 2 minutes.
Feasibility assessed by a safety protocol
A protocol will be kept of all serious adverse events related to the intervention regarding safety during the exercises.
Measured: Safety is assessed during the 12 week intervention period.
Feasibility is assessd by a survey regarding time management of the assessments
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.
Measured: 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 (18)
Changes in gait speed
Gait analysis is conducted under single- and dual-task (ST and DT) condition (UI group: with empty and full bladder) and temporal-spatial gait parameters (gait speed, step length, minimal toe clearance, cadence, stride time, swing width) are measured. Gait analysis is conducted with the Physilog. Gait speed is measured in m/s.
Measured: 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
Gait analysis is conducted under single- and dual-task (ST and DT) condition (UI group: with empty and full bladder) and temporal-spatial gait parameters (gait speed, step length, minimal toe clearance, cadence, stride time, swing width) are measured. Gait analysis is conducted with the Physilog. Step length is measured in m.
Measured: 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 minimal toe clearance
Gait analysis is conducted under single- and dual-task (ST and DT) condition (UI group: with empty and full bladder) and temporal-spatial gait parameters (gait speed, step length, minimal toe clearance, cadence, stride time, swing width) are measured. Gait analysis is conducted with the Physilog. Minimal toe clearance is measured in cm. Smaller values are related to higher risk of tripping and falling. Furthermore, the coefficient of variation (CV) is calculated according to the formula CV [%] = standard deviation (SD) / mean * 100.
Measured: 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 cadence
Gait analysis is conducted under single- and dual-task (ST and DT) condition (UI group: with empty and full bladder) and temporal-spatial gait parameters (gait speed, step length, minimal toe clearance, cadence, stride time, swing width) are measured. Gait analysis is conducted with the Physilog. Cadence is measured in steps/min. Furthermore, the coefficient of variation (CV) is calculated according to the formula CV [%] = standard deviation (SD) / mean * 100.
Measured: 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
Gait analysis is conducted under single- and dual-task (ST and DT) condition (UI group: with empty and full bladder) and temporal-spatial gait parameters (gait speed, step length, minimal toe clearance, cadence, stride time, swing width) are measured. Gait analysis is conducted with the Physilog. Stride time is measured in seconds. Furthermore, the coefficient of variation (CV) is calculated according to the formula CV [%] = standard deviation (SD) / mean * 100.
Measured: 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
Gait analysis is conducted under single- and dual-task (ST and DT) condition (UI group: with empty and full bladder) and temporal-spatial gait parameters (gait speed, step length, toe clearance, cadence, stride time, swing width) are measured. Gait analysis is conducted with the Physilog. Swing width is measured in m.
Measured: 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
The maximal gait speed over at least 4 meters is measured. Gait analysis is conducted with the Physilog. Gait speed is measured in m/s.
Measured: 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 physical performance
To assess physical performance the Short Physical Performance Battery (SPPB) is used resulting in a total score of 12 points with a minimum score of 0 and a maximum score of 4 for each sub-test. The SPPB consist of 3 sub-tests including a balance test (e.g. tandem stance, semi-tandem stance, single leg stance), 4-meter gait test, and 5-chair rises test. A higher score means a better balance performance.
Measured: 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
To assess exercise capacity the 1-Minute Sit to Stand Test (1-MSTST) is used. The participants are required to rise from a chair with their arms across their chest as often as possible in one minute. The number of chair rises will be calculated.
Measured: 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 mental flexibility
To assess mental flexibility (a part of executive functions), the Trail Making Test (TMT) is used pre- and post-intervention. This paper-pencil-test is resulting in a time value in seconds. Less time needed to conducted the test is related to better performance.
Measured: 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.
Change in interference control
To assess interference control (a part of executive functions), the Color Word Interference Test (CWIT) is used pre- and post-intervention. The result is a time value measured in seconds, furthermore, errors are counted. Less time and less errors is related to better performance.
Measured: 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.
Change in memory functions
To assess memory functions, the Wechsler-Memory-Scale-Revised backwards is used pre- and post-intervention. The test is resulting in a point score. The maximal point score is 12 points, the minimal point score is 0 points. Higher scores are related to better performance.
Measured: 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
The Montreal Cognitive Assessment (MoCA) is a test to screen several cognitive domains including memory, language, executive functions, visuospatial skills, attention, concentration, and orientation. The participants can get maximal 30 points, minimum 0 points. The MoCA can be used as a quantitative estimate of the overall cognitive abilities. A higher score indicates a higher overall cognitive function.
Measured: 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 amount of urinary urgency (only measured in UI group)
To assess the amount of urinary urgency during ST and DT walking with full bladder, the participants will complete the urinary sensation scale (USS). The USS is a 5-point likert scale developed to assess feelings of urinary urgency (i.e., intense and/or sudden need to urinate) associated with each urination. The scale goes from 1 (no urgency) to 5 (urge incontinence).
Measured: 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 incontinence episodes (only measured in UI group)
The bladder diary is a common method used to evaluate the frequency and characteristics of incontinence episodes in both research and clinical practice. The participants have to fill in a bladder diary over 7 days.
Measured: Assessment takes place over 1 week before and after the intervention. Pre- and post-measurement changes are calculated.
Changes in quality of life (only measured in UI group): ICIQ-UI
Thw International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI) short form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life of urinary incontinence in men and women. It is scored on a scale from 0-21. With a higher score indicating greater severity of symptoms.
Measured: 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) strength (only measured in UI group)
The PFM strength is evaluated with 3 different assessment methods including manual muscle testing, vaginal pressure device, and electromyography (EMG).
Measured: 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 pelvic floor muscle (PFM) endurance (only measured in UI group)
The PFM endurance is evaluated with 3 different assessment methods including manual muscle testing, vaginal pressure device, and electromyography (EMG).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start26 Oct 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eling DeBruin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eling DeBruin, Swiss Federal Institute of Technology
- Investigators
- Eling de Bruin, Prof., Principal investigator, ETH Zurich - Institute of Human Movement Sciences and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587895
- Sponsor's protocol ID
- BASEC-Nr.: 2020-00578
- Status last verified
- Mar 2021
- First submitted
- 24 Sep 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322Guimaraes V, Sousa I, de Bruin ED, Pais J, Correia MV. Minding your steps: a cross-sectional pilot study using foot-worn inertial sensors and dual-task gait analysis to assess the cognitive status of older adults with mobility limitations. BMC Geriatr. 2023 May 26;23(1):329. doi: 10.1186/s12877-023-04042-6.
PubMed 37237278
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Individualized Exergame Training for Older Adults With Mobility Impairment and/or Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04587895
- Acronym / sponsor ID
- BASEC-Nr.: 2020-00578
- Conditions
- Urinary Incontinence, Mobility Impairment, Older Adults
- Keywords
- exergame, healthy ageing, feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eling DeBruinUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 14 Oct 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MI Intervention | Experimental | Behavioral: VITAAL ExergameThe 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). 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. |
| MI Control | Active comparator | Behavioral: Conventional Training MIParticipants 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). |
| UI Intervention | Experimental | Behavioral: VITAAL ExergameFor 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. |
| UI Control | Active comparator | Behavioral: Conventional Training UIThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| VITAAL Exergame12 weeks training with the VITAAL Exergame. 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. | Behavioural | MI Intervention, UI Intervention |
| Conventional Training UI12 weeks non-individualized conventional training with a training booklet and additional walking exercise. The PFM training booklet is based on exercises that showed a reduction of incontinence in older adults while performing group pelvic floor muscle training (PFMT) and mobility exercises. | Behavioural | UI Control |
| Conventional Training MI12 weeks non-individualized conventional training with a training booklet and additional walking exercise. The exercises are based on recommendations from the "Beratungsstelle für Unfallverhütung" (bfu). | Behavioural | MI Control |
Primary outcome
Feasibility assessed by recruitment rate
Time frame: 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 adherence rate
Time frame: 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
Time frame: 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 assessed by a safety survey
Time frame: 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
Time frame: 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 is assessd by a survey regarding time management of the assessments
Time frame: 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.
18 secondary outcomes
Changes in gait speed
Time frame: 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
Time frame: 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 minimal toe clearance
Time frame: 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 cadence
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 physical performance
Time frame: 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
Time frame: 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 mental flexibility
Time frame: 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.
Change in interference control
Time frame: 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.
Change in memory functions
Time frame: 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
Time frame: 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 amount of urinary urgency (only measured in UI group)
Time frame: 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 incontinence episodes (only measured in UI group)
Time frame: Assessment takes place over 1 week before and after the intervention. Pre- and post-measurement changes are calculated.
Changes in quality of life (only measured in UI group): ICIQ-UI
Time frame: 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) strength (only measured in UI group)
Time frame: 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 pelvic floor muscle (PFM) endurance (only measured in UI group)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- Derived from this study: PubMed 37237278Guimaraes V, Sousa I, de Bruin ED, Pais J, Correia MV. Minding your steps: a cross-sectional pilot study using foot-worn inertial sensors and dual-task gait analysis to assess the cognitive status of older adults with mobility limitations. BMC Geriatr. 2023 May 26;23(1):329. doi: 10.1186/s12877-023-04042-6.
- Individual participant dataSharing planned: No
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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.
Eling de Bruin, Prof. principal investigator
ETH Zurich - Institute of Human Movement Sciences and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VITAAL Exergame, Conventional Training UI and Conventional Training MI in people with Urinary Incontinence and Mobility Impairment, run by Eling DeBruin at 1 site in Switzerland.
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 14 inclusion and 18 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 2 Mar 2021. 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 Switzerland. 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 Jacqueline de Jong, MSc (0041 33 828 88 68, j.dejong@artos.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by recruitment rate (time frame: 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 study lists 6 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 NCT04587895, which also lists 2 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 2 Mar 2021.