- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02107768
Aerobic Exercise in Early Subacute Stroke
Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Ability to understand Swedish language.
- Ability to walk 5 meters with or without the support of any means or person.
- Be able to get up on a cycle ergometer and cycle in their own chosen pace.
- Approval of medically responsible physician to conduct physical training in groups.
Exclusion Criteria:
- Medical or neurological diseases that may affect the exercise execution.
- Patients for whom transportation to and from hospital can not be arranged during intervention period
공부 계획
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: Exercise recommendation
Patients randomized to the control group receive general advice for physical training and activity but no specific training or other rehabilitation efforts
|
Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) . Two fitness goals was to be achieved during the training session 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate. |
|
실험적: Aerobic exercise
The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added. The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20, Rate of Perceived Exertion (Borg 's RPE scale) Two fitness goals was to be achieved during the training session: 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) .Which corresponds to 85% of maximum heart rate. |
Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) . Two fitness goals was to be achieved during the training session 1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate. 2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Aerobic capacity
기간: Baseline,3month
|
cardiorespiratory stress test (Watt)
|
Baseline,3month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Balance
기간: Baseline,3month
|
Time Up and Go(TUG) ,Single Leg Stance(SLS)
|
Baseline,3month
|
|
Walking capacity
기간: Baseline,3month
|
Six minute walk test (6MWT ), 10 meters Walking test
|
Baseline,3month
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EQ5-D
기간: Baseline,3month,6month
|
Quality of life
|
Baseline,3month,6month
|
|
Stroke Impact Scale
기간: Baseline,3month,6month
|
Recovery after stroke, participation
|
Baseline,3month,6month
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Klas Sandberg, Msc,RPT, Rehab East, Local Health Care Östergötland County Council
- 수석 연구원: Marie Kleist, Bsc,RPT, Rehab East, Local Health Care Östergötland County Council
- 수석 연구원: Lars Falk, PhD,MD, Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,
- 수석 연구원: Paul Enthoven, PhD,RPT, Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University
간행물 및 유용한 링크
일반 간행물
- Wijkman MO, Sandberg K, Kleist M, Falk L, Enthoven P. The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise. J Clin Hypertens (Greenwich). 2018 Jan;20(1):56-64. doi: 10.1111/jch.13157. Epub 2018 Jan 16.
- Sandberg K, Kleist M, Falk L, Enthoven P. Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1244-53. doi: 10.1016/j.apmr.2016.01.030. Epub 2016 Feb 20.
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
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. .
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