Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study
2020년 12월 9일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
15
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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간섭 없음: Waitlist Control
Participants will have 16-weeks of no intervention or interaction.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale
기간: 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
기간: 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
기간: 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
기간: Follow-Up
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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 follow-up testing.
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Follow-Up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sleep Quality as measured by the Pittsburgh Sleep Quality Index
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Robert W Motl, PhD, University of Alabama at Birmingham
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 1월 1일
기본 완료 (실제)
2020년 11월 23일
연구 완료 (실제)
2020년 11월 23일
연구 등록 날짜
최초 제출
2019년 8월 16일
QC 기준을 충족하는 최초 제출
2019년 8월 19일
처음 게시됨 (실제)
2019년 8월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 12월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 12월 9일
마지막으로 확인됨
2020년 12월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-300003877
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
다발성 경화증에 대한 임상 시험
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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스
Behavioral Intervention (BIPAMS)에 대한 임상 시험
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University of Alabama at BirminghamNational Multiple Sclerosis Society아직 모집하지 않음
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University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)종료됨
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VA Office of Research and Development모집하지 않고 적극적으로
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Washington University School of MedicineSt. Jude Children's Research Hospital완전한
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University of MichiganNational Institute on Drug Abuse (NIDA)모병