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Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study

9 dicembre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

15

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • University of Alabama at Birmingham

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Behavioral Intervention (BIPAMS)
Participants will complete a 16-week behavioral intervention to increase physical activity levels.
Comportamentale: Behavioral Intervention (BIPAMS)
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.
Altri nomi:
  • Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)
Nessun intervento: Waitlist Control
Participants will have 16-weeks of no intervention or interaction.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Lasso di tempo: Baseline
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.
Baseline
Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Lasso di tempo: Follow-Up
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.
Follow-Up
Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
Lasso di tempo: Baseline
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.
Baseline
Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire
Lasso di tempo: 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.
Follow-Up

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sleep Quality as measured by the Pittsburgh Sleep Quality Index
Lasso di tempo: Baseline
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.
Baseline
Sleep Quality as measured by the Pittsburgh Sleep Quality Index
Lasso di tempo: Follow-up
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.
Follow-up
Sleep Quality as measured by accelerometry
Lasso di tempo: Baseline
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.
Baseline
Sleep Quality as measured by accelerometry
Lasso di tempo: Follow-up
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.
Follow-up
Daytime Sleepiness as measured by the Epworth Sleepiness Scale
Lasso di tempo: Baseline
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.
Baseline
Daytime Sleepiness as measured by the Epworth Sleepiness Scale
Lasso di tempo: Follow-up
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.
Follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Alabama at Birmingham

Investigatori

  • Investigatore principale: Robert W Motl, PhD, University of Alabama at Birmingham

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2020

Completamento primario (Effettivo)

23 novembre 2020

Completamento dello studio (Effettivo)

23 novembre 2020

Date di iscrizione allo studio

Primo inviato

16 agosto 2019

Primo inviato che soddisfa i criteri di controllo qualità

19 agosto 2019

Primo Inserito (Effettivo)

20 agosto 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 dicembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 dicembre 2020

Ultimo verificato

1 dicembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB-300003877

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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