Multiple SclerosisUI-MSNCT06843915
Aerobic Exercise for Urinary Incontinence in Multiple Sclerosis
A study testing Moderate intensity aerobic exercise and Home Exercise Program in people with Multiple Sclerosis and Urinary Incontinence, run by University of Sharjah at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Urinary Incontinence
- What is being tested?
- Moderate intensity aerobic exercise and Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2018to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Exercise as a Therapeutic Approach for Urinary Incon-tinence in Multiple Sclerosis: Insights From a Pilot Randomized Controlled Trial
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.
Read the 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
- Being tested
- Moderate intensity aerobic exercise, Home Exercise Program
- Medical subject headings
- Multiple Sclerosis, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity aerobic exerciseOther
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 ProgramOther
Home Exercise Program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Weeks
Secondary outcomes (1)
Plasma Cortisol level
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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Nov 2018
- Primary completion1 Dec 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alham Al-Sharman, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843915
- Sponsor's protocol ID
- JUST-AA-2015-182
- Acronym
- UI-MS
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise as a Therapeutic Approach for Urinary Incon-tinence in Multiple Sclerosis: Insights From a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06843915
- Acronym / sponsor ID
- UI-MS / JUST-AA-2015-182
- Conditions
- Multiple Sclerosis, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-Intensity Aerobic Exercise group (MIAE) | Experimental | Other: Moderate intensity aerobic exerciseParticipants 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. |
| Home Exercise Program group (HEP) | Active comparator | Other: Home Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity aerobic exerciseParticipants 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. | Other | Moderate-Intensity Aerobic Exercise group (MIAE) |
| Home Exercise ProgramHome Exercise Program | Other | Home Exercise Program group (HEP) |
Primary outcome
Incontinence Questionnaire short-form ques-tionnaire (ICIQ-UI SF)
Time frame: 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.
1 secondary outcome
Plasma Cortisol level
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity aerobic exercise and Home Exercise Program in people with Multiple Sclerosis and Urinary Incontinence, run by University of Sharjah at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Questionnaire short-form ques-tionnaire (ICIQ-UI SF) (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.