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Effects of an Interdisciplinary Fitness and Social Engagement Intervention (InFuSe)

2018년 8월 31일 업데이트: Washington D.C. Veterans Affairs Medical Center

Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration

This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI). Primary outcomes include physical activity (PA), sleep quality, and community integration.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

This randomized controlled trial will have a sample size of 24. Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited. After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise. The intervention will occur weekly and last up to 2 hours. The control group will complete a 10week comprehensive health education program simultaneously. All measures will be collected again, post intervention. A follow-up collection will occur at 3 months post-intervention.

연구 유형

중재적

등록 (실제)

24

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • District of Columbia
      • Washington, District of Columbia, 미국, 20422
        • Washington DC VA Medical Center

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • TBI of at least mild severity using criteria related to disturbance of consciousness
  • Most recent TBI occurred >1 year prior to consent process
  • Medically stable with physician approval to participate

Exclusion Criteria:

  • Unable to provide informed consent and no proxy available
  • Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
  • Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
  • Veteran is currently active in a skilled physical therapy program.
  • Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity

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: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: InFuSE
Experimental group which will receive health education, group discussion, and supervised exercise.
행동: InFuSE
Each session includes a 45-minute education and group discussion. A 60-minute exercise component then completes the session. Each topic was specifically picked and tailored to benefit Veterans with TBI. The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities. The activities are included to help improve understanding and promote group discussion. The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
활성 비교기: Patient Education/Group Discussion
Active control group which will receive health education and group discussion.
행동: Patient Education/Group Discussion
Each week you will participate in a 1 hour health education class with other Veterans. Each topic was specifically picked and tailored for Veterans with TBI. These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Exercise Self-Efficacy Scale (ESES)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Sleep Efficiency
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed. Sleep efficiency is measured by polysomnography.
Change from baseline, after intervention (week 11), and 3 months after (week 24)

2차 결과 측정

결과 측정
측정값 설명
기간
Functional Capacity
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Functional capacity is evaluated using a Bruce protocol treadmill maximal exertion stress test. The maximum amount of work performed by the participant on the treadmill is measured as metabolic equivalents (METs)
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Dynamic Gait Index (DGI)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Pittsburgh Sleep Quality Index (PSQI)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A self-reported measure to evaluate and monitor overall sleep quality.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Mayo Portland Adaptability Index (MPAI-4)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A measure of self-reported quality of life, limitation severity, and community participation after TBI.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Community Reintegration of Service Members (CRIS)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A self-reported measure of the ability of service members to reintegrate after returning to civilian life.
Change from baseline, after intervention (week 11), and 3 months after (week 24)

기타 결과 측정

결과 측정
측정값 설명
기간
California Verbal Learning Test-Second Edition (CVLT-II)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A widely used measure of verbal learning and memory using a multiple-trial list-learning task.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Brief Symptoms Inventory 18 (BSI-18)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A self-report measure of depression, anxiety, somatic concerns, and general distress.
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Post-Traumatic Stress Disorder Checklist (PCL)
기간: Change from baseline, after intervention (week 11), and 3 months after (week 24)
A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.
Change from baseline, after intervention (week 11), and 3 months after (week 24)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Washington D.C. Veterans Affairs Medical Center

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)

2016년 6월 1일

기본 완료 (예상)

2018년 12월 1일

연구 완료 (예상)

2018년 12월 1일

연구 등록 날짜

최초 제출

2017년 3월 28일

QC 기준을 충족하는 최초 제출

2017년 5월 17일

처음 게시됨 (실제)

2017년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 31일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 01798

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. .

InFuSE에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Portugal

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다