Multiple SclerosisNCT03849001
Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS
A study testing Exercise Conditions in people with Multiple Sclerosis and Restless Legs Syndrome, run by University of Alabama at Birmingham.
Trial summary
The purpose of this study is to evaluate the impact of acute leg cycling conditions at three different intensities versus a control condition condition on symptoms of restless legs syndrome (RLS) in persons with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Multiple Sclerosis, Restless Legs Syndrome
- What is being tested?
- Exercise Conditions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Sep 2019
- 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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-54 years of age
- Diagnosis of multiple sclerosis
- Has not experienced a relapse in the last 30 days
- Positive screening for restless legs syndrome
- Restless legs syndrome severity of moderate or greater
- Ambulatory with or without an aide
Who cannot join
- Moderate or high risk for undertaking strenuous or maximal exercise
- Diagnosis of: radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia), renal disease, or diabetes
About this study
Official title: Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis
The purpose of this study is to evaluate the impact of acute leg cycling conditions at three different intensities versus a control condition condition on symptoms of restless legs syndrome (RLS) in persons with multiple sclerosis (MS). This study includes a proposed sample of 24 participants diagnosed with both MS and RLS that will complete four sessions of supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks.
Read the detailed description
The aim of this study is to evaluate the impact of acute leg cycling conditions at three different intensities (i.e., light, moderate, and vigorous) versus a control condition (i.e., quiet rest) on symptoms of RLS in persons with MS. This study involves a within-subjects, repeated measures design that includes a proposed sample of 24 participants diagnosed with both MS and RLS. Participants will complete four sessions with supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks. The order of the three conditions will be randomized and counterbalanced and include: (1) leg cycling with no resistance (i.e., light), (2) leg cycling at moderate intensity, (3) leg cycling at vigorous intensity, and (4) seated, quiet rest (i.e., control condition). The primary study outcome includes the objective measure of RLS severity using the Suggested Immobilization Test (SIT) that will be administered immediately before and immediately after each condition (i.e., light, moderate, vigorous, and quiet rest).
- Conditions
- Multiple Sclerosis, Restless Legs Syndrome
- Being tested
- Exercise Conditions
- Keywords
- Exercise
- Medical subject headings
- Multiple Sclerosis, Restless Legs Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ConditionsBehavioural
Light Exercise
Exercise ConditionsBehavioural
Moderate Exercise
Exercise ConditionsBehavioural
Vigorous Exercise
Exercise ConditionsBehavioural
Seated Rest
| Study group | Role | What they receive |
|---|---|---|
| Exercise Conditions | Experimental | Participants will undergo four "Exercise Conditions" (i.e., light intensity leg cycling, moderate intensity leg cycling, vigorous intensity leg cycling, and a seated, quiet rest) in a randomized, counterbalanced order. Receives: Behavioral: Exercise Conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the light exercise condition to capture pre-exercise RLS severity.
Measured: 10 minutes pre-exercise condition
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the light exercise condition to capture post-exercise RLS severity.
Measured: 10 minutes post-exercise condition
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the moderate exercise condition to capture pre-exercise RLS severity.
Measured: 10 minutes pre-exercise condition
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the moderate exercise condition to capture post-exercise RLS severity.
Measured: 10 minutes post-exercise condition
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the vigorous exercise condition to capture pre-exercise RLS severity.
Measured: 10 minutes pre-exercise condition
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the vigorous exercise condition to capture post-exercise RLS severity.
Measured: 10 minutes post-exercise condition
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the seated, quiet rest condition to capture pre-rest RLS severity.
Measured: 10 minutes pre-rest (Control) condition
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the seated, quiet rest condition to capture post-rest RLS severity.
Measured: 10 minutes post-rest (Control) condition
Secondary outcomes (6)
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms.
Measured: Baseline through screening
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms.
Measured: Baseline through week 1
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms.
Measured: week 1 through week 2
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms.
Measured: week 2 through week 3
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms.
Measured: week 3 through week 4
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
In order to characterize RLS symptom severity over the previous week, participants will be asked to complete the IRLS. The IRLS is a validated 10-question survey that provides a global score commonly used to assess the overall severity of symptoms as well as the frequency and impact of symptoms on daily life in reference to the previous week. Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with with a range of 0 to 40 and higher scores indicating greater severity of symptoms.
Measured: week 4 through week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Study halted prematurely, prior to enrollment of first participant
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.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert W Motl, University of Alabama at Birmingham
- Investigators
- Robert W Motl, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849001
- Sponsor's protocol ID
- IRB-300002951
- Status last verified
- Nov 2019
- First submitted
- 19 Feb 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Leg Cycling at Different Intensities on Restless Legs Syndrome Severity in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03849001
- Acronym / sponsor ID
- IRB-300002951
- Conditions
- Multiple Sclerosis, Restless Legs Syndrome
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 21 Feb 2019 (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.
The purpose of this study is to evaluate the impact of acute leg cycling conditions at three different intensities versus a control condition condition on symptoms of restless legs syndrome (RLS) in persons with multiple sclerosis (MS). This study includes a proposed sample of 24 participants diagnosed with both MS and RLS that will complete four sessions of supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks.
Detailed description
The aim of this study is to evaluate the impact of acute leg cycling conditions at three different intensities (i.e., light, moderate, and vigorous) versus a control condition (i.e., quiet rest) on symptoms of RLS in persons with MS. This study involves a within-subjects, repeated measures design that includes a proposed sample of 24 participants diagnosed with both MS and RLS. Participants will complete four sessions with supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks. The order of the three conditions will be randomized and counterbalanced and include: (1) leg cycling with no resistance (i.e., light), (2) leg cycling at moderate intensity, (3) leg cycling at vigorous intensity, and (4) seated, quiet rest (i.e., control condition). The primary study outcome includes the objective measure of RLS severity using the Suggested Immobilization Test (SIT) that will be administered immediately before and immediately after each condition (i.e., light, moderate, vigorous, and quiet rest).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Conditions | Experimental | Behavioral: Exercise ConditionsParticipants will undergo four "Exercise Conditions" (i.e., light intensity leg cycling, moderate intensity leg cycling, vigorous intensity leg cycling, and a seated, quiet rest) in a randomized, counterbalanced order. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-54 years of age
- Diagnosis of multiple sclerosis
- Has not experienced a relapse in the last 30 days
- Positive screening for restless legs syndrome
- Restless legs syndrome severity of moderate or greater
Key exclusion criteria (2 listed)
- Moderate or high risk for undertaking strenuous or maximal exercise
- Diagnosis of: radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia), renal disease, or diabetes
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 |
|---|---|---|
| Exercise ConditionsLight Exercise | Behavioural | Exercise Conditions |
| Exercise ConditionsModerate Exercise | Behavioural | Exercise Conditions |
| Exercise ConditionsVigorous Exercise | Behavioural | Exercise Conditions |
| Exercise ConditionsSeated Rest | Behavioural | Exercise Conditions |
Primary outcome
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes pre-exercise condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the light exercise condition to capture pre-exercise RLS severity.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes post-exercise condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the light exercise condition to capture post-exercise RLS severity.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes pre-exercise condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the moderate exercise condition to capture pre-exercise RLS severity.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes post-exercise condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the moderate exercise condition to capture post-exercise RLS severity.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes pre-exercise condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the vigorous exercise condition to capture pre-exercise RLS severity.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes post-exercise condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the vigorous exercise condition to capture post-exercise RLS severity.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes pre-rest (Control) condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately before the seated, quiet rest condition to capture pre-rest RLS severity.
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT)
Time frame: 10 minutes post-rest (Control) condition
Participants will be reclined at a 45 degree angle on a padded treatment table with legs outstretched and will be instructed to avoid any voluntary movement of the legs for the 60 minute duration of the test. Periodic limb movements during wakefulness (PLMW) will be quantified using two accelerometers and self-reported severity of leg discomfort during the SIT will be assessed using a visual analog scale (VAS) that ranges from 0 (no discomfort) to 100 (extreme discomfort) every five minutes during the test. The SIT will be completed immediately after the seated, quiet rest condition to capture post-rest RLS severity.
6 secondary outcomes
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Time frame: Baseline through screening
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Time frame: Baseline through week 1
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Time frame: week 1 through week 2
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Time frame: week 2 through week 3
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Time frame: week 3 through week 4
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale (IRLS)
Time frame: week 4 through week 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Robert W Motl, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Conditions in people with Multiple Sclerosis and Restless Legs Syndrome, run by University of Alabama at Birmingham.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Restless Legs Syndrome Severity as measured by the Suggested Immobilization Test (SIT) (time frame: 10 minutes pre-exercise condition). The study lists 8 primary outcomes in all. 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 2 Dec 2019.