Aerobic Exercise for Urinary Incontinence in Multiple Sclerosis

NCT06843915 | Completed

• 1 other identifier: JUST-AA-2015-182
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Incontinence Questionnaire short-form ques-tionnaire (ICIQ-UI SF)

  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.

  6 Weeks

Secondary Outcomes (1)

• Plasma Cortisol level

  6 Weeks

Study Arms (2)

Moderate-Intensity Aerobic Exercise group (MIAE)

EXPERIMENTAL

Participants in the moderate-intensity aerobic exercise (MIAE) group engaged in a 40-minute supervised session using the StepOne-SCIFIT recumbent stepper machine. The session included a 5-minute warm-up at 25 watts, followed by 30 minutes of moderate-intensity exercise, main-taining a stepping rate of 90-100 steps per minute. The workload was adjusted to keep the participant's heart rate within the target heart rate range (THRR), calculated using the Karvonen formula. During the first three weeks, the exercise intensity was set at 50-59% of heart rate reserve (HRR), and for the remaining three weeks, it was increased to 60-69% of HRR. Polar heart rate monitors were used to assess heart rate before and after each session. Participants kept weekly exercise logs to monitor compliance.

Other: Moderate intensity aerobic exercise

Home Exercise Program group (HEP)

ACTIVE COMPARATOR

Participants in the home exercise program (HEP) group received a Digital video disc (DVD) exercise and a printed manual covering low-intensity, non-aerobic exercises to control for general activity levels. The DVD, developed for individuals with movement disorders, was in Arabic and included warm-up and cool-down activities, flexibility, strength, balance, endurance exercises, and relaxation techniques. The examiner reviewed the DVD and precautions with each participant to ensure correct execution. Participants were also monitored for adherence through weekly exercise logs.

Other: Home Exercise Program

Interventions

Moderate intensity aerobic exercise OTHER

Participants in the MIAE group engaged in a 40-minute supervised session using the StepOne-SCIFIT recumbent stepper machine. The session included a 5-minute warm-up at 25 watts, followed by 30 minutes of moderate-intensity exercise, main-taining a stepping rate of 90-100 steps per minute. The workload was adjusted to keep the participant's heart rate within the target heart rate range (THRR), calculated using the Karvonen formula. During the first three weeks, the exercise intensity was set at 50-59% of heart rate reserve (HRR), and for the remaining three weeks, it was increased to 60-69% of HRR. Polar heart rate monitors were used to assess heart rate before and after each session. Participants kept weekly exercise logs to monitor compliance.

Moderate-Intensity Aerobic Exercise group (MIAE)

Home Exercise Program OTHER

Home Exercise Program

Home Exercise Program group (HEP)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

Naseem Oudah

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

Multiple Sclerosis; Urinary Incontinence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate prof

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 25, 2025
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

JO (1)