- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05241171
The "Step4Life" Randomized Control Trial in Hemodialysis
The Impact of Use of a Wearable Pedometer and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The "Step4Life" Randomized Control Trial
연구 개요
상세 설명
Physical activity is an important modifiable behavior that is known to impact morbidity and mortality. The patients with advance kidney disease especially those on chronic hemodialysis are deconditioned with decreased muscle mass, and have co-morbidities such as anemia, malnutrition, and depression. These factors may explain why hemodialysis patients are known to have very low physical activity relative to healthy populations. We have recently demonstrated that hemodialysis patients are frequently sedentary, walk less with lower levels of physical activity. Thus, this provides an opportunity to design interventions to improve and sustain physical activity levels in hemodialysis patients.
There is a growing experience of digital technology and intervention delivery modalities to promote physical activity in chronic comorbid conditions, but little is known in hemodialysis patients. We set forward to test a weekly coaching intervention guided by a wearable pedometer to determine whether it would be feasible, promote physical activity, and be sustained for 12 weeks in hemodialysis patients. Equipped with pedometer data, informing subjects quantitatively about their levels of physical activity relative to other hemodialysis patients, might promote physical activity in this high-risk population.
We conduct a 12-week, open label, randomized controlled trial to determine the feasibility and effectiveness of providing structured feedback instruction (e.g., behavioral feedback, goal setting) along with a wearable pedometer (FitBit ®) in sustaining or improving physical activity levels in chronic hemodialysis patients as compared to the wearable pedometer (automated self-managed) alone. I hypothesized that the structured feedback intervention coupled with the wearable pedometer would be feasible, would improve physical activity, and would be sustainable for 12 weeks in hemodialysis patients.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국, 92101
- University of California San Diego
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
1) HD for ≥3 months, 2) age ≥18 years, and 3) ability to walk with or without assistive devices,
Exclusion Criteria:
1) wheelchair bound, 2) unstable severe health conditions (e.g., acute infections, heart failure (HF) NYHA class 4 and/or unstable angina), 3) hospitalization within 3 months before enrollment for non-access related reasons, or 4) clinically recognized cognitive impairment including dementia or psychosis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Fitbit plus Feedback Intervention
Participants who were randomized to the provider-feedback intervention arm received goal setting, and feedback graphs and charts,
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The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.
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활성 비교기: Fitbit alone
Participants in self-managed control group were provided access to the Fitbit website or app but did not receive any feedback on their activity level from the study team.
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The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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the absolute change from baseline in step counts per week from baseline to 12-weeks between randomized groups.
기간: 12 weeks
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weekly step counts measured with Fitbit
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12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rakesh Malhotra, MD, MPH, University of California, San Diego
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
신체 활동에 대한 임상 시험
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
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