Aerobic Exercise for Urinary Incontinence in Multiple Sclerosis

NCT ID: NCT06843915

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-05-01

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.

Conditions

Multiple Sclerosis; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Moderate-Intensity Aerobic Exercise group (MIAE)

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.

Group Type: EXPERIMENTAL

Moderate intensity aerobic exercise

Intervention Type: 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.

Home Exercise Program group (HEP)

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.

Group Type: ACTIVE_COMPARATOR

Home Exercise Program

Intervention Type: OTHER

Home Exercise Program

Interventions

Moderate intensity aerobic exercise

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.

Intervention Type: OTHER

Home Exercise Program

Home Exercise Program

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sharjah

OTHER

Sponsor Role: lead

Responsible Party

Alham Al-Sharman

Associate prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Naseem Oudah

Irbid, , Jordan

Countries

Jordan

Other Identifiers

JUST-AA-2015-182

Identifier Type: -

Identifier Source: org_study_id