Clinical trial NCT05779709: Reformer Pilates Exerises in Bladder and Bowel Dysfunction
Official title: The Effectiveness of Reformer Pilates Exercises on Symptoms and Quality of Life in Children With Bladder and Bowel Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BLADDER AND BOWEL DYSFUNCTION
Keywords: Reformer
Pilates
Urotherapy
Quality of life
Bladder and bowel dysfunction
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children between ages 5-18, who were diagnosed with bladder and bowel dysfunction without any neurological abnormalities were invited. Children with neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal tract, inflammatory bowel disease or any other disorder affecting bladder or bowel function and who requested withdrawal from the study at any stage were excluded.

The children who met the inclusion criteria were invited for pre-intervention meeting and assessments. The aim of study and reformer pilates exercise intervention explained parents and children during the meeting. The children and their parents who want to join exercise sessions during the study were assigned in the reformer pilates group and who did not accept to perform reformer pilates exercises were assigned in the urotherapy group
Primary purpose: OTHER

Brief summary: Bladder and bowel dysfunction (BBD) describes the urinary tract symptoms associated with bowel complaints. Urotherapy and pharmacological treatments are used in conservative BBD treatment. Pilates is an exercise method that includes a series of movements that both strengthen and increase flexibility of the entire body without focusing on a specific muscle. Reformer pilates is a specific type that provides resistance exercise at certain weights with the pulley system relying basically on the same principles. Pilates exercises provide breathing and activation of the deep stabilizing muscles of the trunk in coordination with the pelvic floor muscles (PFMs).

Despite the increasing number of health care professionals using the pilates-based approach in rehabilitation. The pilates-based exercises in rehabilitation is still insufficient in the literature7. To our knowledge, none of studies which were investigated the usefulness of pilates-based exercise principle in children with BBD. This study was aimed to investigate the effect of reformer pilates exercises on bladder and bowel dysfunction symptoms and quality of life in children with bladder and bowel dysfunction.

Detailed description: Bladder and bowel dysfunction (BBD) describes the urinary tract symptoms associated with bowel complaints. BBD symptoms are thought to represent 40% of pediatric urology consultations. In children who do not have any neurological or physiological problems, micturition and defecation occur with the coordinated work of the involuntary bladder and bowel, voluntary contracting external urethral sphincter and external anorectal sphincter. For normal micturition and defecation, the pelvic floor muscles must be able to relax properly. This relaxation may not be achieved even in children with no neurological or physiological problems.

Urotherapy and pharmacological treatments are used in conservative BBD treatment. Urotherapy includes education of the child and family, diet (adequate fiber and fluid consumption), regular optimal voiding, daily physical activity, teaching normal toilet use, pelvic floor muscle training and relaxation. Pilates is an exercise method that includes a series of movements that both strengthen and increase flexibility of the entire body without focusing on a specific muscle. It includes exercises that can work the pelvic floor muscles (PFMs), while avoiding intense abdominal contractions, holding breath, or straining that can create increased pressure on the pelvic floor.

Reformer pilates is a specific type that provides resistance exercise at certain weights with the pulley system relying basically on the same principles. Pilates exercises provide breathing and activation of the deep stabilizing muscles of the trunk in coordination with the PFMs. It includes exercises that focus on pelvic stability, mobility and body alignment. PFMs activation is carried out simultaneously with the trunk muscles in various positions in coordination with breathing. Such exercises are known to have an important role related to continence, maintenance of intra-abdominal pressure and respiratory mechanics.

Despite the increasing number of health care professionals using the pilates-based approach in rehabilitation. The pilates-based exercises in rehabilitation is still insufficient in the literature. To our knowledge, none of studies which were investigated the usefulness of pilates-based exercise principle in children with BBD. This study was aimed to investigate the effect of reformer pilates exercises on bladder and bowel dysfunction symptoms and quality of life in children with bladder and bowel dysfunction.

Eligibility criteria: Inclusion Criteria:

* Children between ages 5-18,
* Diagnosed with bladder and bowel dysfunction without any neurological abnormalities

Exclusion Criteria:

* Children with neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal tract, inflammatory bowel disease or any other disorder affecting bladder or bowel function and who requested withdrawal from the study at any stage were excluded.

Primary outcomes:
measure: Voiding Disorders Symptom Scoring
timeFrame: 8 weeks
measure: Bladder and Bowel Dysfunction Questionnaire
timeFrame: 8 weeks
measure: Pediatric İncontinence Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan kalyoncu üniversity
Study officials:
affiliation: Hasan Kalyoncu University
name: Yavuz Yakut
role: STUDY_CHAIR
References:
citation: Aguiar LM, Franco I. Bladder Bowel Dysfunction. Urol Clin North Am. 2018 Nov;45(4):633-640. doi: 10.1016/j.ucl.2018.06.010. Epub 2018 Sep 7.
citation: Wennergren HM, Oberg BE, Sandstedt P. The importance of leg support for relaxation of the pelvic floor muscles. A surface electromyograph study in healthy girls. Scand J Urol Nephrol. 1991;25(3):205-13. doi: 10.3109/00365599109107948.
citation: Berry A. Helping children with dysfunctional voiding. Urol Nurs. 2005 Jun;25(3):193-200; quiz 201.
citation: Ladi-Seyedian SS, Sharifi-Rad L, Kajbafzadeh AM. Management of Bladder Bowel Dysfunction in Children by Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises: A Randomized Clinical Trial. Urology. 2020 Oct;144:182-187. doi: 10.1016/j.urology.2020.07.015. Epub 2020 Jul 25.
citation: Lausen A, Marsland L, Head S, Jackson J, Lausen B. Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial. BMC Womens Health. 2018 Jan 12;18(1):16. doi: 10.1186/s12905-017-0503-y.
citation: Pedriali FR, Gomes CS, Soares L, Urbano MR, Moreira EC, Averbeck MA, de Almeida SH. Is pilates as effective as conventional pelvic floor muscle exercises in the conservative treatment of post-prostatectomy urinary incontinence? A randomised controlled trial. Neurourol Urodyn. 2016 Jun;35(5):615-21. doi: 10.1002/nau.22761. Epub 2015 Mar 21.
citation: Kaya Narter F, Tarhan F, Narter KF, Sabuncu K, Alay Eser R, Akin Y, Ay P. Reliability and validity of the Bladder and Bowel Dysfunction Questionnaireamong Turkish children. Turk J Med Sci. 2017 Dec 19;47(6):1765-1769. doi: 10.3906/sag-1601-122.
citation: Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.
citation: Bower WF, Sit FK, Bluyssen N, Wong EM, Yeung CK. PinQ: a valid, reliable and reproducible quality-of-life measure in children with bladder dysfunction. J Pediatr Urol. 2006 Jun;2(3):185-9. doi: 10.1016/j.jpurol.2005.07.004. Epub 2005 Aug 19.