NCT00258492

Brief 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 exercise intervention will demonstrate:

  1. 1.reduced RLS symptoms;
  2. 2.improved sleep quality;
  3. 3.reduced daytime sleepiness.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2005

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2005

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 26, 2007

Status Verified

July 1, 2006

First QC Date

November 22, 2005

Last Update Submit

January 25, 2007

Conditions

Restless Legs SyndromeInsomnia

Keywords

Restless legs syndromeInsomniaDaytime sleepinessExercise

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Aerobic exerciseBEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Restless Legs SyndromeSleep Initiation and Maintenance DisordersDisorders of Excessive SomnolenceMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Claire C. Bourguet, Ph.D.

    Northeastern Ohio Universities College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 24, 2005

Study Start

December 1, 2005

Study Completion

January 1, 2007

Last Updated

January 26, 2007

Record last verified: 2006-07