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- Registre américain des essais cliniques
- Essai clinique NCT04061681
Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study
9 décembre 2020 mis à jour par: Robert W Motl, University of Alabama at Birmingham
Efficacy of Project BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study
The purpose of this study is to evaluate the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing restless legs syndrome (RLS) severity in persons with multiple sclerosis (MS) and RLS.
The study includes a proposed sample of 20 persons with MS and RLS that will be randomized into either a 16-week behavioral intervention arm aimed at increasing physical activity or a 16-week wait-list control arm.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The primary aim of the proposed pilot RCT involves examining the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing RLS severity in persons with MS and RLS.
Secondarily, the investigators will be assessing changes in sleep quality and daytime sleepiness following the behavioral intervention.
The study includes a proposed sample of 20 persons with MS and RLS that will complete a baseline testing session for measures of physical activity, restless legs syndrome severity, sleep quality, and daytime sleepiness.
Participants will then be randomized into one of two study arms: (1) a 16-week Social Cognitive Theory-based behavioral intervention aimed at increasing physical activity; or (2) 16-week waitlist control with the option of completing the intervention upon completion of the study.
All participants will complete a follow-up testing session at the conclusion of each 16-week arm.
Type d'étude
Interventionnel
Inscription (Réel)
15
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- University of Alabama at Birmingham
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Diagnosis of multiple sclerosis
- Relapse free in the past 30 days
- Positive screen for restless legs syndrome
- Non-active (not engaging in 30 minutes of activity per day on more than 2 days per week in the previous six months)
- Ambulatory without assistance
- Internet and email access
Exclusion Criteria:
- Diagnosis of radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia) renal disease, or diabetes
- Screen at moderate or high risk for undertaking strenuous or maximal exercise
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Behavioral Intervention (BIPAMS)
Participants will complete a 16-week behavioral intervention to increase physical activity levels.
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This 16-week behavioral intervention teaches people the skills, techniques, and strategies based on Social Cognitive Theory of behavior change for modifying and self-regulating health behaviors, including physical activity.
The behavioral intervention consists of two primary components, namely a dedicated Internet website and one-on-one video chats with a behavioral coach via SkypeTM.
Autres noms:
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Aucune intervention: Waitlist Control
Participants will have 16-weeks of no intervention or interaction.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Délai: Baseline
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Participants will complete the International Restless Legs Syndrome Study Group Scale (IRLS), a 10-item questionnaire 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 over the previous week.Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with total scores ranging from 0-40 and higher scores indicating a greater severity of symptoms.This will be completed at the baseline testing session.
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Baseline
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Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Délai: Follow-Up
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Participants will complete the International Restless Legs Syndrome Study Group Scale (IRLS), a 10-item questionnaire 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 over the previous week.Overall symptom severity scores are determined by combining the sum of the answers on the questionnaire with total scores ranging from 0-40 and higher scores indicating a greater severity of symptoms.
This will be completed at the follow-up testing session.
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Follow-Up
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Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
Délai: Baseline
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Participants will complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ) as a measure of the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 minutes or more over a typical week.
Summary scores are calculated by multiplying the number of strenuous, moderate, and mild bouts by 9, 5, and 3, respectively, and summing those values into an overall score that ranges from 0 to 119; higher scores are represent a greater volume of physical activity.
This will be completed at baseline testing.
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Baseline
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Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
Délai: Follow-Up
|
Participants will complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ) as a measure of the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 minutes or more over a typical week.
Summary scores are calculated by multiplying the number of strenuous, moderate, and mild bouts by 9, 5, and 3, respectively, and summing those values into an overall score that ranges from 0 to 119; higher scores are represent a greater volume of physical activity.
This will be completed at follow-up testing.
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Follow-Up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Sleep Quality as measured by the Pittsburgh Sleep Quality Index
Délai: Baseline
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The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality and sleep disturbances over the past four weeks and containing seven different components of sleep.
Components of sleep are scored from 0 (fairly good) to 3 (very bad) and component scores are summed for a global score ranging from 0-21; higher scores are indicative of worse sleep quality.
Participants will complete this questionnaire at baseline testing.
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Baseline
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Sleep Quality as measured by the Pittsburgh Sleep Quality Index
Délai: Follow-up
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The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality and sleep disturbances over the past four weeks and containing seven different components of sleep.
Components of sleep are scored from 0 (fairly good) to 3 (very bad) and component scores are summed for a global score ranging from 0-21; higher scores are indicative of worse sleep quality.
Participants will complete this questionnaire at Follow-up testing.
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Follow-up
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Sleep Quality as measured by accelerometry
Délai: Baseline
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Accelerometry provides device-measured aspects of sleep quality including sleep onset latency, time in bed, total sleep time, frequency of awakenings, time awake after sleep onset, and sleep efficiency.
Participants will be instructed to wear one ActiGraph GT3X+ accelerometer device on the non-dominant wrist each night (i.e., during time in bed for scheduled sleep time) for seven nights following the baseline testing session.
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Baseline
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Sleep Quality as measured by accelerometry
Délai: Follow-up
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Accelerometry provides device-measured aspects of sleep quality including sleep onset latency, time in bed, total sleep time, frequency of awakenings, time awake after sleep onset, and sleep efficiency.
Participants will be instructed to wear one ActiGraph GT3X+ accelerometer device on the non-dominant wrist each night (i.e., during time in bed for scheduled sleep time) for seven nights following the follow-up testing session.
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Follow-up
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Daytime Sleepiness as measured by the Epworth Sleepiness Scale
Délai: Baseline
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The Epworth Sleepiness Scale (ESS) is an 8-item questionnaire whereby participants are asked to rate how likely they would be to doze off or fall asleep during eight different situations in "recent times" to provide a global score of daytime sleepiness.
Items are scored on a range of 0 (would never doze) to 3 (high chance of dozing) and summed to provide a global score of daytime sleepiness ranging between 0 and 24 with higher scores indicating more daytime sleepiness.
Participants will complete the questionnaire at baseline testing.
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Baseline
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Daytime Sleepiness as measured by the Epworth Sleepiness Scale
Délai: Follow-up
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The Epworth Sleepiness Scale (ESS) is an 8-item questionnaire whereby participants are asked to rate how likely they would be to doze off or fall asleep during eight different situations in "recent times" to provide a global score of daytime sleepiness.
Items are scored on a range of 0 (would never doze) to 3 (high chance of dozing) and summed to provide a global score of daytime sleepiness ranging between 0 and 24 with higher scores indicating more daytime sleepiness.
Participants will complete the questionnaire at Follow-up testing.
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Follow-up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Robert W Motl, PhD, University of Alabama at Birmingham
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2020
Achèvement primaire (Réel)
23 novembre 2020
Achèvement de l'étude (Réel)
23 novembre 2020
Dates d'inscription aux études
Première soumission
16 août 2019
Première soumission répondant aux critères de contrôle qualité
19 août 2019
Première publication (Réel)
20 août 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 décembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 décembre 2020
Dernière vérification
1 décembre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Processus pathologiques
- Maladies du système nerveux
- Maladies du système immunitaire
- Maladies auto-immunes démyélinisantes, SNC
- Maladies auto-immunes du système nerveux
- Maladies démyélinisantes
- Maladies auto-immunes
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Troubles du sommeil et de l'éveil
- Manifestations neurologiques
- Manifestations neurocomportementales
- Maladie
- Dyskinésies
- Troubles psychomoteurs
- Parasomnies
- Sclérose en plaques
- Sclérose
- Syndrome
- Agitation psychomotrice
- Syndrome des jambes sans repos
Autres numéros d'identification d'étude
- IRB-300003877
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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