Aerobic Exercise for Urinary Incontinence in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Urinary Incontinence

• Registration Number: NCT06843915
• Lead Sponsor: University of Sharjah

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.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-05-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incontinence Questionnaire short-form ques-tionnaire (ICIQ-UI SF)	6 Weeks	The International Consultation on Incontinence Questionnaire short-form ques-tionnaire (ICIQ-UI SF) was used to assess the presence and frequency of UI in our pa-tient cohort. The questionnaire has been validated and widely used in clinical and re-search settings to evaluate urinary symptoms and quality of life. It serves as a valuable tool for healthcare providers and researchers in evaluating the prevalence, frequency, severity, and the impact of UI on the quality of life (QoL) of individuals affected by this neurological condition as per MS. The Arabic version of the ICIQ_UI_SF was used in this study. The total ICIQ-UI SF score ranges from 0 to 21 points, with the severity being classified according to the total score: 0-7 points for mild UI, 8-12 points for moderate UI, and 13-21 points for severe UI.

Secondary Outcome Measures

Name	Time	Method
Plasma Cortisol level	6 Weeks	Blood samples were collected for measurement of cortisol from MS participants in both groups at 8:00 am ±1 hour to standardize for daily physiological variations in cor-tisol. Cortisol determinations was examined using competitive enzyme-linked im-mune-sorbent assay technology while Serum/plasma serotonin level was examined using Sandwich enzyme-sorbent assay technology. After blood collection, all blood samples were centrifuged at 1500 x g for 15 minutes in order to collect serum. Following to this, serums were stored at -80°C until used. A competitive ELISA kits for quantita-tive analysis of total serum cortisol was used. All assays were performed according to the instructions provided by the manufacturer.

Trial Locations

Locations (1)

Naseem Oudah; 🇯🇴 Irbid, Jordan