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FlexToBa for People With Multiple Sclerosis

2017년 2월 21일 업데이트: Edward McAuley, University of Illinois at Urbana-Champaign

Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention

The purpose of this study is to test the effectiveness of a DVD-delivered, home-based six-month physical activity intervention for people with Multiple Sclerosis.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Persons with MS are less likely to be active than their healthy counterparts, a statistic that is compounded by the symptom manifestations of MS. However, there is increasing evidence to support the importance of physical activity in MS. Unfortunately, structured, safe, and efficacious physical activity programs that are often conducted in medical or university settings are often not accessible to many older adults with or without MS. We propose to conduct a randomized controlled pilot trial testing the efficacy of a DVD-delivered physical activity intervention which targets factors that have the potential to reduce disability in older adults with MS. This DVD-based intervention has been previously approved by the IRB at the University of Illinois for a similar study with low-active, community-dwelling older adults (IRB Protocol Number: 09765). This novel intervention provides systematic, programmatic activities with alternative versions of each exercise that allow individuals of all capabilities to complete the program successfully. It focuses on improving flexibility, strength, and balance and has been demonstrated to be feasible, well-accepted, and efficacious in a large sample of older adults without MS. Importantly, intervention resulted in clinically significant improvements in the Short Physical Performance Battery, reliable determinant of disability, institutionalization, morbidity, and mortality. If such an intervention was equally successful in older persons with MS, this could have considerable public health impact.

연구 유형

중재적

등록 (실제)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Illinois
      • Urbana, Illinois, 미국, 61801
        • University of Illinois at Urbana-Champaign

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

50년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months;
  • aged 50 years and older;
  • fluent in English;
  • relapse-free in the last 30 days;
  • ambulatory with minimal assistance(i.e., walk independently or with a single-point assistive walking device such as a cane);
  • the provision of medical clearance for participation in a physical activity program by participants' physicians, along with a physician-confirmed diagnosis of MS (communication with physicians will be facilitated by research staff).

Exclusion Criteria:

  • self-reported physical activity on a regular basis within the last six months (2 times or more per week);
  • younger than 50 years of age;
  • relapse in the last 30 days;
  • no regular access to a television;
  • no physician-confirmed diagnosis of multiple sclerosis;
  • unable to successfully score above 21 (out of 39)on the Telephone Interview of Cognitive Status questionnaire (TICS-M).

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
실험적: Experimental: FlexToBa physical activity DVD
Participants in this arm will receive a physical activity program delivered by DVD that focuses on exercises targeting flexibility, toning and balance. These exercises will be progressive in nature throughout the six months and will also focus on modifications for all ability levels. Participants will be provided with three DVDs including: an Introduction to physical activity, Sessions 1-3, and Sessions 4-6, which they will be asked to watch and participate in over the course of six months.
행동: Home-based, DVD-delivered physical activity
Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance. Exercises will be progressive over the six-months and will highlight modifications for varying levels. This program will be delivered on 3 DVDs. Participants will be asked to exercise with the DVD at least three times per week.
활성 비교기: Usual care-Wait list
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
행동: Behavioral: Usual care/Wait list
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
기간: Baseline and six months

The measurements will include:

Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance
Baseline and six months
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
기간: Baseline and six-months

Measurements will include:

Timed 20-foot walk test -- walk 25 feet as quickly as possible;
Baseline and six-months
Change in assessments of functional fitness assessments in sedentary adults with MS
기간: Baseline and six-months

Measurements will include:

6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes;
Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
기간: Baseline and six-months

Measurements will include:

Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength;
Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
기간: Baseline and six-months

Measurements will include:

Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility)
Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
기간: Baseline and six-months

Measurements will include:

Upper body strength -- bicep curls consisting of lifting a light hand-weight as many times as possible in 30-seconds;
Baseline and six-months
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
기간: Baseline and six-months

Measurements will include:

Balance -- a timed (up to 30-seconds) unassisted one-leg stand test with eyes open on each leg.
Baseline and six-months
Change from baseline to six-months in assessments of reported quality of life in people with MS
기간: Baseline and six months
The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS.
Baseline and six months
Change from baseline to six-months in assessments of reported quality of life in people with MS
기간: Baseline and six-months
The Satisfaction with Life Scale will be used to assess global life satisfaction and is sensitive enough to detect changes in participants' perceptions over the course of a clinical intervention.
Baseline and six-months

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
기간: Baseline and six months
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
Baseline and six months
Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
기간: Baseline and six months
Participants' situation-specific self-confidence for physical activity will be assessed using The Barriers Self-Efficacy Scale, which taps subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation.
Baseline and six months
Changes in physical activity relating to specified exercise program in sedentary adults with MS
기간: Baseline and six months
Adherence to exercise program as documented by daily exercise logs.
Baseline and six months
Objective changes in physical activity in sedentary adults with MS
기간: Baseline and six months
Objective assessment of physical activity via accelerometry over seven days time.
Baseline and six months
Self-reported changes in physical activity in sedentary adults with MS
기간: Baseline and six months
Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities.
Baseline and six months
Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
기간: Baseline and six-months
Participants' situation-specific self-confidence for physical activity will be assessed using The Gait Self-Efficacy Scale, which will assess participants' beliefs in their capabilities to negotiate stairs and objects in their path.
Baseline and six-months
Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
기간: Baseline and six-months
The Exercise Self-Efficacy Scale will assess participants' beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future.
Baseline and six-months
Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
기간: Baseline and six-months
Walking Self-Efficacy Scale for Duration will assess participants' beliefs in their physical capability to successfully complete incremental 5-minute intervals (up to 40 minutes)of walking at a moderately fast pace.
Baseline and six-months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Illinois at Urbana-Champaign

협력자

National Multiple Sclerosis Society

수사관

  • 수석 연구원: Edward McAuley, PhD, University of Illinois at Urbana-Champaign

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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

2013년 10월 1일

기본 완료 (실제)

2014년 9월 1일

연구 완료 (실제)

2014년 9월 1일

연구 등록 날짜

최초 제출

2013년 10월 18일

QC 기준을 충족하는 최초 제출

2013년 11월 20일

처음 게시됨 (추정)

2013년 11월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 2월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 2월 21일

마지막으로 확인됨

2017년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IL-0009

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

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위치

3
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