- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04061681
Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study
9 december 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
15
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama at Birmingham
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Inget ingripande: Waitlist Control
Participants will have 16-weeks of no intervention or interaction.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sleep Quality as measured by the Pittsburgh Sleep Quality Index
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Follow-up
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Robert W Motl, PhD, University of Alabama at Birmingham
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2020
Primärt slutförande (Faktisk)
23 november 2020
Avslutad studie (Faktisk)
23 november 2020
Studieregistreringsdatum
Först inskickad
16 augusti 2019
Först inskickad som uppfyllde QC-kriterierna
19 augusti 2019
Första postat (Faktisk)
20 augusti 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 december 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 december 2020
Senast verifierad
1 december 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Patologiska processer
- Sjukdomar i nervsystemet
- Immunsystemets sjukdomar
- Demyeliniserande autoimmuna sjukdomar, CNS
- Autoimmuna sjukdomar i nervsystemet
- Demyeliniserande sjukdomar
- Autoimmuna sjukdomar
- Sömnstörningar, inneboende
- Dyssomni
- Vakna sömnstörningar
- Neurologiska manifestationer
- Neurobehavioral manifestationer
- Sjukdom
- Dyskinesier
- Psykomotoriska störningar
- Parasomnier
- Multipel skleros
- Skleros
- Syndrom
- Psykomotorisk agitation
- Willis-Ekboms sjukdom
Andra studie-ID-nummer
- IRB-300003877
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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