Restless Legs SyndromePhase 1/2NCT00258492
Restless Legs Syndrome Exercise Intervention
A Phase 1/2 study testing Aerobic exercise in people with Restless Legs Syndrome and Insomnia, run by Northeastern Ohio Universities College of Medicine.
Trial summary
A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS sufferers who participate in an aerobic… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Restless Legs Syndrome, Insomnia
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jan 2007
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets case definition for RLS with symptoms at least one day a week
- Age 40 and older
- Moderate or severe insomnia
- Able to engage in moderate exercise
- Permission of primary care physician to participate in exercise.
Who cannot join
- Serum ferritin below 50 ng/ml
- Body mass index (BMI) greater than 40
- History of recent myocardial infarction or stroke
- Alcohol use, more than 3 drinks a day
- Current use of medications for sleep
About this study
Official title: The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS sufferers who participate in an aerobic exercise intervention will demonstrate:
- reduced RLS symptoms;
- improved sleep quality;
- reduced daytime sleepiness.
Read the detailed description
We will implement an exercise intervention among persons who suffer from RLS.
Study members will be Veterans, over the age of 40, who have been identified as RLS cases as part of our larger study of "The Prevalence and Outcomes of Restless Legs Syndrome among Veterans." We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control. Each arm of the study will be 3 months duration.
The protocol for the intervention will consist of twice weekly supervised exercise sessions. The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60% of VO2max. The control will be weekly support group meetings.
Outcomes will be measured using standardized sleep scales, actigraphy, and daily sleep and exercise logs.
- Conditions
- Restless Legs Syndrome, Insomnia
- Being tested
- Aerobic exercise
- Keywords
- Restless legs syndrome, Insomnia, Daytime sleepiness, Exercise
- Medical subject headings
- Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
RLS symptom severity, measured bi-weekly
Secondary outcomes (3)
Sleep efficiency, measured bi-weekly
Insomnia severity, measured bi-weekly
Day time sleepiness, measured bi-weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startDec 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Northeastern Ohio Universities College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Louis Stokes VA Medical Center, The University of Akron, U.S. Army Medical Research and Development Command, Pfizer
- Investigators
- Claire C. Bourguet, Ph.D., Principal investigator, Northeastern Ohio Universities College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258492
- Sponsor's protocol ID
- DAMD17-03-1-0082
- Other IDs
- DAMD17-03-1-0082
- Status last verified
- Jul 2006
- First submitted
- 22 Nov 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
- ClinicalTrials.gov ID
- NCT00258492
- Acronym / sponsor ID
- DAMD17-03-1-0082
- Conditions
- Restless Legs Syndrome, Insomnia
- Keywords
- Restless legs syndrome, Insomnia, Daytime sleepiness, Exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Northeastern Ohio Universities College of MedicineUniversity, hospital or other
- Collaborators
- Louis Stokes VA Medical Center, The University of Akron, U.S. Army Medical Research and Development Command, Pfizer
- Study start
- Dec 2005
- Study completion
- Jan 2007
- First posted
- 24 Nov 2005 (estimated)
- 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.
A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS sufferers who participate in an aerobic exercise intervention will demonstrate:
- reduced RLS symptoms;
- improved sleep quality;
- reduced daytime sleepiness.
Detailed description
We will implement an exercise intervention among persons who suffer from RLS.
Study members will be Veterans, over the age of 40, who have been identified as RLS cases as part of our larger study of "The Prevalence and Outcomes of Restless Legs Syndrome among Veterans." We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control. Each arm of the study will be 3 months duration.
The protocol for the intervention will consist of twice weekly supervised exercise sessions. The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60% of VO2max. The control will be weekly support group meetings.
Outcomes will be measured using standardized sleep scales, actigraphy, and daily sleep and exercise logs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets case definition for RLS with symptoms at least one day a week
- Age 40 and older
- Moderate or severe insomnia
- Able to engage in moderate exercise
- Permission of primary care physician to participate in exercise.
Key exclusion criteria (5 listed)
- Serum ferritin below 50 ng/ml
- Body mass index (BMI) greater than 40
- History of recent myocardial infarction or stroke
- Alcohol use, more than 3 drinks a day
- Current use of medications for sleep
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 |
|---|---|---|
| Aerobic exercise | Behavioural | – |
Primary outcome
RLS symptom severity, measured bi-weekly
3 secondary outcomes
Sleep efficiency, measured bi-weekly
Insomnia severity, measured bi-weekly
Day time sleepiness, measured bi-weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2007.
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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.
Claire C. Bourguet, Ph.D. principal investigator
Northeastern Ohio Universities College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aerobic exercise in people with Restless Legs Syndrome and Insomnia, run by Northeastern Ohio Universities College of Medicine.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jan 2007. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
RLS symptom severity, measured bi-weekly. 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 26 Jan 2007.