NCT01953549已完成3 期
Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Gait speed and Barthel Index (BI) (co-primary endpoint)
研究概览
简要总结
The aim of this study is to investigate whether a 4-week physical fitness training (target intervention) in stroke patients (subacute stage) increase the walking speed and activities of daily living compared with a control intervention (relaxation exercises). The target or control intervention is performed in addition to standard rehabilitation treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patient considered unable to comply with study requirements
- •stroke due to intracranial hemorrhage primarily due to bleeding from ruptured aneurysm or arteriovenous malformation
- •patients with progressive stroke
- •unable to perfom the required exercises due to
- •medical problems
- •musculo-skeletal problems
- •neurological problems
- •required help to at least 1 persons to walk before stroke due to neurological or non-neurological co-morbidities
- •life expectancy of less than 1 year as determined by responsible physician
- •alcohol or drug addiction within the last 6 months
- •significant current psychiatric illness as defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality
- •current participation in another intervention study
研究组 & 干预措施
physical fitness training
Experimental
aerobic physical fitness training
干预措施: physical fitness training (Procedure)
relaxation
Active Comparator
non-aerobic training
干预措施: relaxation (Procedure)
结局指标
主要结局
Gait speed and Barthel Index (BI) (co-primary endpoint)
时间窗: 3 months post stroke vs baseline
comparing gait speed (m/s) and points achieved in BARTHEL Index in aerobic and non-aroebic training group 3 months after stroke vs baseline (before intervention)
次要结局
- Quality of life (QoL)(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- mood(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- Gait speed and Barthel Index (BI)(directly after intervention; 6 months post stroke; all vs baseline)
- motor function(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- cognitive function(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- sleep(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- Assessment of safety(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- mobility(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- Disability(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
- Physical fitness(directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline)
- Maximal walking speed and Barthel-Index(3 months post stroke vs. baseline)
研究者
Agnes Flöel
Prof. Dr.
Charite University, Berlin, Germany
研究点 (14)
Loading locations...
相似试验
已完成
不适用
Fitness Intervention Trial for StrokeStrokeNCT00786045McGill University60
已完成
不适用
Evaluation of Physical Fitness After StrokeStrokeNCT01107210KU Leuven50
已完成
不适用
Fitness intervention trial post-stroke (FITS): Enhancing walking endurance using home rehabilitation programsCirculatory SystemStrokeISRCTN45155177McGill University (Canada)130
已完成
不适用
The Effect of an Inpatient Home-work Exercise Program on Leg Function After StrokeCerebrovascular Accident (Stroke)NCT00908479University of British Columbia142
进行中（未招募）
不适用
Encourage the practice of Physical Activity in patients after stroke via a Program of Physical Exercises performed in the community: a feasibility studyStroke, not specified as haemorrhage or infarctionRBR-6bdmskEscola de Educação Física, Fisioterapia e Terapia Ocupacional da Universidade Federal de Minas Gerais