- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03411720
Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
2020년 6월 19일 업데이트: J. Andrew Taylor, Spaulding Rehabilitation Hospital
Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life.
After injury persons with SCI engage in fewer social interactions, spend more time sedentary, and are less likely to leave the home.
This leads to restricted social participation that, in turn, contributes to greater psychological problems and negatively impacts the lives of adults with SCI.
Intense, structured exercise has substantial potential benefits for improving psychosocial wellbeing among persons with SCI, but accessible exercise options are few and cannot achieve high intensities of whole-body exercise.
This work will use approaches to overcome the barriers to intense exercise.
The investigators will use hybrid functional electrical stimulation row training (FESRT) to allow for a more intense exercise stimulus, potentially having a greater impact on psychosocial wellbeing.
There is initial evidence that persons with mobility impairments who are highly physically active demonstrate better psychosocial wellbeing compared with those who have low levels of physical activity.
A limitation to understanding the influence of exercise on psychosocial wellbeing is the lack of robust and time-dependent measures.
The investigators will use a smartphone-based research application to measure psychosocial well-being, thus decreasing self-report bias and capturing in-the-moment behavioral and self-report data.
연구 개요
연구 유형
중재적
등록 (실제)
26
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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Massachusetts
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Cambridge, Massachusetts, 미국, 02139
- Spaulding Rehabilitation Network
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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:
Adults (>18 years of age)
- Be in good health (asymptomatic for acute treatable illness) and medically cleared to exercise
- Own an iPhone or Android smartphone with the capacity to download and run the research platform (able to log into to the relevant app store, install the app on their own phone, and run the app).
- Be able to understand, communicate with and be understood by research personnel or Interpreters
- Be interested in participating and provide informed consent
- Have a SCI with motor or sensory deficits and use a wheelchair as primary means of mobility
- Have an injury level only as high as C4 to allow sufficient arm function for rowing
Exclusion Criteria:
- Participants will not have previously completed FESRT
- Acute illness
- Musculoskeletal injuries that have not healed completely
- Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, -Unstable angina
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
- uncontrolled dysrhythmias
- Recent history of congestive heart failure that has not been evaluated and effectively treated
- Severe stenotic or regurgitant valvular disease
- Hypertrophic cardiomyopathy
- Unhealed pressure ulcer Stage 2 or higher at relevant contact sites during 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: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: FES-row-training
Subjects will perform 4 months of FES-row-raining
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Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
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다른: Wait-list time control
Subjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training
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Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
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활성 비교기: Arms-only-row-training
Subjects will perform 4 months of arms-only row training before being allowed to engage in 4 months of FES-row-training
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Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Depression
기간: Each week during the 4 months
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Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression
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Each week during the 4 months
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Pain Severity
기간: Each week during the 4 months
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Difference between groups in pain severity, rated on a 0-10 scale ("0 being no pain and 10 being pain so severe you couldn't stand it"); Within-individual Correlation of exercise intensity with pain.
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Each week during the 4 months
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Pain Interference
기간: Each week during the 4 months
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Difference between groups in pain interference in daily life activities ("0.
Not at all 1.
A little bit 2. Moderately 3. Quite a bit 4. Extremely"); Within-individual Correlation of exercise intensity with pain.
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Each week during the 4 months
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Anxiety
기간: Each week during the 4 months
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Difference between groups in anxiety (Spinal Cord Injury Quality of Life Anxiety Short Form); Within-individual Correlation of exercise intensity with anxiety.
Minimum score is 9, Maximum score is 45.
Higher scores indicate higher anxiety.
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Each week during the 4 months
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Satisfaction with Social Participation
기간: Each week during the 4 months
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Difference between groups in satisfaction with social roles and activities (Spinal Cord Injury Quality of Life Satisfaction with Social Roles and Activities Short Form); Within-individual Correlation of exercise intensity with satisfaction with social participation.
The Minimum score is 20 and the maximum score is 50.
Higher values indicate greater satisfaction with social participation.
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Each week during the 4 months
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Ability to participate in social roles
기간: Each week during the 4 months
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Difference between groups in ability to participate in social roles and activities.
Spinal Cord Injury Quality of Life Ability to Participate in Social Roles and Activities Short Form.
Within-individual Correlation of exercise intensity with ability to participate in social roles.
The Minimum score is 20 and the maximum score is 50.
Higher values indicate greater satisfaction with social participation.
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Each week during the 4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Health Complications
기간: Each week during the 4 months
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Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.
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Each week during the 4 months
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Community Mobility
기간: Each week during the 4 months
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Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.
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Each week during the 4 months
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Social Connectivity: Frequency
기간: Each week during the 4 months
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Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.
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Each week during the 4 months
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Social Connectivity: Reciprocity
기간: Each week during the 4 months
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Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.
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Each week during the 4 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: J. Andrew Taylor, Spaulding Rehabilitation Hospital/Harvard Medical School
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)
2018년 2월 28일
기본 완료 (실제)
2020년 5월 31일
연구 완료 (실제)
2020년 5월 31일
연구 등록 날짜
최초 제출
2018년 1월 5일
QC 기준을 충족하는 최초 제출
2018년 1월 25일
처음 게시됨 (실제)
2018년 1월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 19일
마지막으로 확인됨
2020년 6월 1일
추가 정보
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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