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

NCT04587895 | Unknown DMC

• 1 other identifier: BASEC-Nr.: 2020-00578
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the feasibility of an individualized video game training (VITAAL Exergame) for older adults with mobility impairments and/or urinary incontinence. In addition, the effect of the newly developed training program on motor and cognitive functions is examined. This study is a national study. The development of the exergame was carried out at the Fraunhofer AICOS research center in Portugal and further studies are being conducted in international collaboration with the University of Montréal in Canada, KU Leuven in Belgium and ETH Zurich. The Exergame consists of a video game based training, which is performed with step movements. These movements are detected by two sensors on the feet. The video game should make the training fun and motivate to train. The training will include specific cognitive and physical functions. Special emphasis will be put on a continuous interaction and integration of motor and cognitive functions. An intact cognitive-motor interaction as well as balance and strength form the basis for all everyday performances, especially for safe and accident-free movement in older adults. In the Exergame VITAAL, balance is trained with step-based games. Strength, especially leg strength, is trained through Tai-Chi-like movements/exercises. The pelvic floor training takes place using a vaginal probe that measures the contractions of the pelvic floor. The training games on the VITAAL Exergame have been adapted for this purpose and are controlled via the probe. All participants receive an individually tailored training session that is optimally adapted to their needs based on the results of the pre-measurement. Participants with urinary incontinence also receive an integrated pelvic floor training. The study includes 32-52 seniors with mobility impairments and 8-28 older adults with urinary incontinence. Balance and strength, gait pattern, cognitive functions and pelvic floor specific functions will be measured before and after the training in order to detect any changes. The training should be carried out during 12 weeks, with a maximum of two weeks break/holidays. There are two measurement dates with all examinations, whereby one measurement date lasts approx. 1.5 hours. All study participants can continue their everyday life as usual.

Conditions

Urinary Incontinence; Mobility Impairment; Older Adults

Keywords

exergame; healthy ageing; feasibility

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

  Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.

• Changes in step length

  Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.

• Changes in minimal toe clearance

  Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.

• Changes in cadence

  Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.

• Changes in stride time

  Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 10-15 minutes.

Study Arms (4)

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.

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).

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.

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.

Behavioral: Conventional Training UI

Interventions

VITAAL Exergame BEHAVIORAL

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.

MI Intervention; UI Intervention

Conventional Training UI BEHAVIORAL

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.

UI Control

Conventional Training MI BEHAVIORAL

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).

MI Control

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: For the Study with Urinary Incontinence only female participants will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eling DeBruin: lead

Study Sites (1)

Physio SPArtos

Bern, Interlaken, 3800, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 39704322 DERIVED

• Guimaraes 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.

  PMID: 37237278 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eling de Bruin, Prof.

  ETH Zurich - Institute of Human Movement Sciences and Sport

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline de Jong, MSc

CONTACT

0041 33 828 88 68; j.dejong@artos.ch

Melanie Thalmann, MSc

CONTACT

0041 44 633 08 52; melanie.thalmann@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 14, 2020
• Study Start: October 26, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)