此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Feasibility Study of an Individualized Exergame Training for Older Adults With MI and/or UI (VITAAL)

2021年3月1日 更新者:Eling DeBruin

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (预期的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Interlaken
      • Bern、Interlaken、瑞士、3800
        • 招聘中
        • Physio SPArtos
        • 接触:
        • 接触:
        • 副研究员:
          • Jacqueline de Jong, MSc
        • 副研究员:
          • Annemarie Mastebroek, BSc
        • 副研究员:
          • Moniek Dokter, BSc
        • 副研究员:
          • Vincent Becker Hoff, BSc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:MI Intervention
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.
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.
有源比较器:MI Control
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).
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).
实验性的:UI Intervention
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.
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.
有源比较器:UI Control
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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Feasibility assessed by recruitment rate
大体时间: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.
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
大体时间: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.
The adherence rate is assessed during the 12 week intervention period.
Feasibility assessed by attrition rate
大体时间: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.
The attrition rate is assessed during the 12 week intervention period.
Feasibility assessed by a safety survey
大体时间: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.
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
大体时间: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.
Safety is assessed during the 12 week intervention period.
Feasibility is assessd by a survey regarding time management of the assessments
大体时间: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.
The questions will be assessed after the pre- and post-measurements within two weeks before and after the intervention. The survey lasts 1 minute.

次要结果测量

结果测量
措施说明
大体时间
心理灵活性的变化
大体时间:评估在干预前后两周内的测量前和测量后进行。计算测量前和测量后的变化。 TMT 持续 5 分钟。
为了评估心理灵活性(执行功能的一部分),在干预前后使用了跟踪测试 (TMT)。 此纸笔测试会产生以秒为单位的时间值。 执行测试所需的时间越短,性能越好。
评估在干预前后两周内的测量前和测量后进行。计算测量前和测量后的变化。 TMT 持续 5 分钟。
Changes in gait speed
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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
大体时间: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.
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.
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)
大体时间: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.
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).
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)
大体时间:Assessment takes place over 1 week before and after the intervention. Pre- and post-measurement changes are calculated.
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.
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
大体时间: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.
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.
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)
大体时间: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.
The PFM strength is evaluated with 3 different assessment methods including manual muscle testing, vaginal pressure device, and electromyography (EMG).
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)
大体时间: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.
The PFM endurance is evaluated with 3 different assessment methods including manual muscle testing, vaginal pressure device, and electromyography (EMG).
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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Eling de Bruin, Prof.、ETH Zurich - Institute of Human Movement Sciences and Sport

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年10月26日

初级完成 (预期的)

2021年10月1日

研究完成 (预期的)

2021年10月1日

研究注册日期

首次提交

2020年9月24日

首先提交符合 QC 标准的

2020年10月13日

首次发布 (实际的)

2020年10月14日

研究记录更新

最后更新发布 (实际的)

2021年3月2日

上次提交的符合 QC 标准的更新

2021年3月1日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅