- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02296268
Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke (STROKE-TRIC)
Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke: Translating Research Into Clinical Care
연구 개요
상세 설명
Research question: To what extent does an on-site aerobic exercise screening and prescription clinic effect uptake of aerobic exercise and patient outcomes in in-patient stroke rehabilitation?
Design: Pre-post cohort design to explore real-world application and feasibility
Aim 1. Establish an aerobic exercise screening and prescription clinic (herein 'Aerobics Clinic') at the NSRC.
Aim 2. Assess the potential impact of the Aerobics Clinic on the self-efficacy of physiotherapists at NSRC regarding clinical utilization of aerobic exercise in in-patient stroke rehabilitation.
Method: An assessment of the physiotherapy participants' self-efficacy regarding the clinical utilization of aerobic exercise post-stroke will be conducted prior to, and after, implementation of the Clinic.
Aim 3: Assess the potential impact of the Aerobics Clinic on prescription and treatment practices regarding aerobic exercise among patients in stroke rehabilitation at the NSRC.
Method: Prior to, and after, implementation of the Clinic the actual utilization of aerobic exercise in the practices of the physiotherapy participants will be assessed using heart rate monitoring, activity monitoring, and health record review.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Nova Scotia
-
Halifax, Nova Scotia, 캐나다, B3H3J5
- QEII Health Sciences Centre
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Male or female adults
- Diagnosed with ischemic or hemorrhagic stroke
- Referred to NSRC for stroke rehabilitation
Exclusion Criteria:
- Have contraindications to exercise testing using American College of Sports Medicine guidelines
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Pre-Clinic Stroke Group
In- or out-patients with diagnosis of ischemic or hemorrhagic stroke who have been referred to the NSRC prior to the establishment of the Clinic and are willing/able to provide written informed consent and have no contraindications to exercise testing.
Utilization of aerobic exercise will be monitored during their physiotherapy sessions (Aim 3).
|
Patients will be referred to the Clinic by their physiotherapist to be assessed regarding their safety and readiness to participate in aerobic training.
If they are deemed to be safe and ready, an aerobic exercise prescription will be written to guide the implementation of a safe and effective training protocol.
Patients deemed to be at moderate to high risk will need to be cleared for testing by a physician on the stroke service.
A cardiologist will be consulted about specific concerns re cardiac status.
|
|
Post-Clinic Stroke Group
In- or out-patients with diagnosis of ischemic or hemorrhagic stroke who have been referred to the NSRC after the establishment of the Clinic and are willing/able to provide written informed consent and have no contraindications to exercise testing.
Each patient will undergo an assessment in the Aerobics Clinic and will receive a prescription for aerobic training based on the assessment findings.
Utilization of aerobic exercise will be monitored during their physiotherapy sessions (Aim 3).
|
Patients will be referred to the Clinic by their physiotherapist to be assessed regarding their safety and readiness to participate in aerobic training.
If they are deemed to be safe and ready, an aerobic exercise prescription will be written to guide the implementation of a safe and effective training protocol.
Patients deemed to be at moderate to high risk will need to be cleared for testing by a physician on the stroke service.
A cardiologist will be consulted about specific concerns re cardiac status.
|
|
Stroke Rehabilitation Physiotherapists
Physiotherapists whose current practice involves working full-time or part-time on in- or out-patient stroke service at the NSRC.
Their self-efficacy regarding the clinical utilization of aerobic exercise post-stroke will be conducted prior to, and after, implementation of the Aerobics Clinic.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from admission 6-Minute Walk Test at discharge
기간: admission and discharge (baseline and 5-6 weeks later)
|
To assess change between admission and discharge in distance walked without manual support in 6 minutes
|
admission and discharge (baseline and 5-6 weeks later)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from admission 10-Meter Walk at discharge
기간: admission and discharge (baseline and ~5-6 weeks later)
|
To assess change between admission and discharge in n walking speed over a 10-metre distance
|
admission and discharge (baseline and ~5-6 weeks later)
|
|
Change from admission resting blood pressure at discharge
기간: admission and discharge (baseline and 5-6 weeks later)
|
To assess change between admission and discharge in resting systolic and diastolic blood pressure
|
admission and discharge (baseline and 5-6 weeks later)
|
|
Change from admission abdominal girth at discharge
기간: admission and discharge
|
To assess change between admission and discharge in waist circumference in relaxed standing position
|
admission and discharge
|
|
Change from admission Stroke-Specific Quality of Life at discharge
기간: admission and discharge (baseline and 5-6 weeks later)
|
To assess change between admission and discharge in quality of life questionnaire
|
admission and discharge (baseline and 5-6 weeks later)
|
|
Change from admission Readiness for Physical Activity Scale at discharge
기간: admission and discharge (baseline and 5-6 weeks later)
|
To assess change between admission and discharge in readiness to engage in physical activity
|
admission and discharge (baseline and 5-6 weeks later)
|
|
Change from admission Fatigue Severity Scale at discharge
기간: admission and discharge (baseline and 5-6 weeks later)
|
To assess change between admission and discharge in level of fatigue
|
admission and discharge (baseline and 5-6 weeks later)
|
공동 작업자 및 조사자
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CDHA-RS 2015-223
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .