Wii Fit Game Based Abdomino-Pelvic Training In Urinary Incontinence

NCT03727269 | Completed DMC

• 1 other identifier: RiphahIU Mizna Saleh
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to determine the effect of Wii fit based abdomino-pelvic training on strength of pelvic floor muscles and on symptoms of urinary incontinence in females. An experimental, randomized controlled trial will be performed. Both reproductive and postmenopausal females with stress urinary incontinence will be included. 40 participants would be randomly distributed in experimental group (n=20) receiving wii fit based abdomino-pelvic training and control group (n=20) receiving conventional pelvic floor exercises. Pelvic floor strength would be assessed before and after by Digital method and EMG biofeedback. Urinary symptoms would be assessed by bladder diary, pad test and International consultation on Incontinence Questionnaires. Health related Quality of life questionnaire would also be used as an outcome measure. Data will be analyzed on SPSS 21 version using descriptive and inferential statistics

Conditions

Incontinence, Urinary

Keywords

Wii Fit; Urinary Incontinence; Females; Abdomino-Pelvic Training

Outcome Measures

Primary Outcomes (1)

• EMG biofeedback

  EMG biofeedback device shows electrical activity of pelvic floor muscles and can assist with both muscle strengthening AND relaxation training

  8 week

Secondary Outcomes (1)

• Michigan Incontinence Symptoms Index:

  8th week

Study Arms (2)

Wii Fit Training Experimental Group

EXPERIMENTAL

receiving Wii fit based abdomino-pelvic training

Other: Wii Fit Training Experimental Group

Conventional Training Control Group

ACTIVE COMPARATOR

receiving conventional pelvic floor exercises.

Other: Conventional Training

Interventions

Wii Fit Training Experimental Group OTHER

Experimental group receiving wii fit game based abdomino-pelvic training. A specific protocol was developed by the researchers. Wii fit games which promote exercises focusing on the abdominopelvic cavity strengthening, using as a therapeutic means a Wii™ console with a Wii Fit Plus™ CD game. The protocol was design that which playing games participant perform different pelvic movements such as anteversion, retroversion, lateral tilt and circumduction that maintain trunk control and stabilization with mild abdomino-pelvic muscle activation. Duration of each game is 5 minutes with 90 seconds interval between them twice a week. After performing the sequence of virtual games, a series of abdominopelvic and lower limb muscle stretching exercises will done.

Wii Fit Training Experimental Group

Conventional Training OTHER

Control group (n=20) receiving conventional pelvic floor exercises. Conventional exercises includes: 1. Knack Maneuver (Ashton -Miller 1998, 2008) 2. Pelvic floor strengthening: kegel Exercise. 3. -Lumbo-Pelvic Stabilization Exercise. 4. Functional Training/ PFM Contraction during ADL 5. Correction of biomechanical/structural deformities

Conventional Training Control Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Postmenopausal females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females with only stress urinary incontinence (SUI).

You may not qualify if:

• Females with urinary tract infection.
• Females with myopathy, neurological abnormalities, cognitive or physical disorder that could hinder in training and assessment.
• Pelvic floor muscle strength 0 on Modified oxford grading scale and pelvic organ prolapse greater than or equal to 3 on pelvic organ Quantification (POP-Q) system.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (13)

• Wood LN, Anger JT. Urinary incontinence in women. BMJ. 2014 Sep 15;349:g4531. doi: 10.1136/bmj.g4531.

  PMID: 25225003 BACKGROUND

• Hilton P. Urinary incontinence in women. Br Med J (Clin Res Ed). 1987 Aug 15;295(6595):426-32. doi: 10.1136/bmj.295.6595.426. No abstract available.

  PMID: 3115486 BACKGROUND

• Osborn DJ, Strain M, Gomelsky A, Rothschild J, Dmochowski R. Obesity and female stress urinary incontinence. Urology. 2013 Oct;82(4):759-63. doi: 10.1016/j.urology.2013.06.020. Epub 2013 Aug 22.

  PMID: 23972338 BACKGROUND

• Burgio KL, Matthews KA, Engel BT. Prevalence, incidence and correlates of urinary incontinence in healthy, middle-aged women. J Urol. 1991 Nov;146(5):1255-9. doi: 10.1016/s0022-5347(17)38063-1.

  PMID: 1942274 BACKGROUND

• Dobson HD, Pearl RK, Orsay CP, Rasmussen M, Evenhouse R, Ai Z, Blew G, Dech F, Edison MI, Silverstein JC, Abcarian H. Virtual reality: new method of teaching anorectal and pelvic floor anatomy. Dis Colon Rectum. 2003 Mar;46(3):349-52. doi: 10.1097/01.DCR.0000054639.29160.9E.

  PMID: 12626910 BACKGROUND

• Martinho NM, Silva VR, Marques J, Carvalho LC, Iunes DH, Botelho S. The effects of training by virtual reality or gym ball on pelvic floor muscle strength in postmenopausal women: a randomized controlled trial. Braz J Phys Ther. 2016 Mar 22;20(3):248-57. doi: 10.1590/bjpt-rbf.2014.0148.

  PMID: 27437716 BACKGROUND

• Botelho S, Martinho NM, Silva VR, Marques J, Carvalho LC, Riccetto C. Virtual reality: a proposal for pelvic floor muscle training. Int Urogynecol J. 2015 Nov;26(11):1709-12. doi: 10.1007/s00192-015-2698-5. Epub 2015 Apr 30.

  PMID: 25925487 BACKGROUND

• Steenstrup B, Giralte F, Bakker E, Grise P. [Evaluation of the electromyography activity of pelvic floor muscle during postural exercises using the Wii Fit Plus(c). Analysis and perspectives in rehabilitation]. Prog Urol. 2014 Dec;24(17):1099-105. doi: 10.1016/j.purol.2014.09.046. Epub 2014 Oct 23. French.

  PMID: 25450755 BACKGROUND

• Elliott V, de Bruin ED, Dumoulin C. Virtual reality rehabilitation as a treatment approach for older women with mixed urinary incontinence: a feasibility study. Neurourol Urodyn. 2015 Mar;34(3):236-43. doi: 10.1002/nau.22553. Epub 2014 Jan 10.

  PMID: 24415577 BACKGROUND

• Bertotto A, Schvartzman R, Uchoa S, Wender MCO. Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial. Neurourol Urodyn. 2017 Nov;36(8):2142-2147. doi: 10.1002/nau.23258. Epub 2017 May 16.

  PMID: 28508398 BACKGROUND

• Capelini MV, Riccetto CL, Dambros M, Tamanini JT, Herrmann V, Muller V. Pelvic floor exercises with biofeedback for stress urinary incontinence. Int Braz J Urol. 2006 Jul-Aug;32(4):462-8; discussion 469. doi: 10.1590/s1677-55382006000400015.

  PMID: 16953917 BACKGROUND

• Thubert T, Deffieux X, Jousse M, Guinet-Lacoste A, Ismael SS, Amarenco G. Influence of a distraction task on pelvic floor muscle contraction. Neurourol Urodyn. 2015 Feb;34(2):139-43. doi: 10.1002/nau.22524. Epub 2014 Feb 12.

  PMID: 24519688 BACKGROUND

• 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

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

• imran Amjad

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental group

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 1, 2018
• Study Start: November 15, 2018
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)