Clinical trial NCT06843915: Aerobic Exercise for Urinary Incontinence in Multiple Sclerosis
Official title: Aerobic Exercise as a Therapeutic Approach for Urinary Incon-tinence in Multiple Sclerosis: Insights From a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Urinary Incontinence
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Limited studies has investigated the effect of aerobic exercise program on urinary inconitenance in people with multiple sclerosis. This study aims to explore the effects of a six weeks moderate-intensity aerobic exercise intervention on UI and UI related bi-omarkers specifically cortisol using. Urinary incontinence and blood samples were assessed after 6-week intervention of aerobic exercise.

Detailed description: Urinary incontinence (UI) is a prevalent and debilitating issue in people with Multiple Sclerosis (PwMS). This condition reduces the quality of life for those affected by MS, imposing substantial physical, emotional, and social burdens. Certainly, emphasizing the necessity for effective UI management strategies in the context of MS. Physical activity was associated with a significant reduction in urinary incontinence. Aerobic exercise, commonly referred to as "cardio," improves the heart's efficiency in pumping oxygenated blood, thus supplying essential oxygen to active muscles.

During aerobic exercise, stabilizing muscles such as the abdominals and adductors are significantly engaged. Given that Pelvic floor muscles (PFMs) are critical for the voluntary urinary continence mechanism, they also serve as stabilizers and postural muscles, capable of reflexive activation during physical activity. Therefore, PFMs are essential for maintaining continence and providing effective pelvic stabilization. Recent systematic review has found that there is moderate evidence that the aerobic and/or resistance exercise program associated with PFM training compared to usual care can reduce UI in pregnant women.

This pilot study utilized a single-blinded, randomized controlled design to estab-lish the groundwork for calculating effect sizes for future Phase II randomized con-trolled trials (RCTs), following Hertzog's (2008) guidelines. The study compared two groups: an intervention group participating in a six-week moderate-intensity aerobic exercise program, and a control group engaged in non-aerobic exercises at home.

Participants were recruited from patients with MS attending routine neurology appointments at King Abdullah University Hospital (KAUH-Irbid, Jordan) between November 2018 and May 2020. Initial eligibility screening was conducted, and eligible patients were invited to participate. Patients who had previously consented to be contacted for future research or had participated in other studies were also approached. Information about the study was shared via the Jordanian Multiple Sclerosis Society, and interested patients underwent further eligibility screening.

Eligibility criteria: Inclusion Criteria:

* Confirmed MS diagnosis by a neurologist based on the revised McDonald criteria.
* Expanded Disability Status Scale (EDSS) score between 3 and 5.5
* No symptom exacerbation in the 30 days before testing
* Aged 18 years or older
* Ability to provide informed consent
* Absence of urinary incontinence (UI) before MS onset
* no history of pelvic surgery, radiotherapy, or bladder stones.

Exclusion Criteria:

* Inability to perform the exercise test on a recumbent stepper
* Recent acute ischemic cardiovascular event or coronary artery bypass surgery within the past three months
* severe uncorrected visual impairments
* Uncontrolled hy-pertension (blood pressure \> 190/110 mmHg) despite medication.

Primary outcomes:
measure: Incontinence Questionnaire short-form ques-tionnaire (ICIQ-UI SF)
timeFrame: 6 Weeks
Secondary outcomes:
measure: Plasma Cortisol level
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Naseem Oudah
Study officials:
References: