Monitoring Sedentary Behavior and Light Physical Activity in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sedentary time
研究概览
简要总结
This randomized control trial (RCT) aims to test the effect of a 12 weeks tailored behavioral intervention on stroke survivors living in the community and compare the results to a control group of stroke survivors participating in standard care. The intervention's purpose is to lower the time spend with sedentary behavior and raise the level of physical activity in stroke survivors throughout their everyday life. The intervention contains two motivational interviews with a focus on goal setting, action planning, motivation, fatigue management, and general information on life after stroke. The primary outcome for behavior change is objectively measured physical activity using an activity tracker (ActivPal4 Micro) and secondary glycohemoglobin and changes in quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified ischemic stroke or intracerebral hemorrhage
- •Modified rankin score (mRS) 1-3 at discharge
- •Discharged with at rehabilitation plan within 1-14 hospitalization days
- •Able to ambulate independently
- •Speak and understand Danish
排除标准
- •Unable to give informed consent
- •Unable to ambulate independently
- •Mental illness
- •Other co-morbidity like terminal cancer.
结局指标
主要结局
Sedentary time
时间窗: 12 weeks follow-up
Time participants spend with sedentary behavior compared between the intervention and control group
次要结局
- The General Self-efficacy Scale (GSES)(Baseline,12 and 26 weeks follow-up)
- Physical activity scale (PAS2)(Baseline,12 and 26 weeks follow-up)
- The Multi-dimensional Fatigue Inventory (MFI-20) questionnaire(Baseline,12 and 26 weeks follow-up)
- The Fugl Meyer Assessment (FMA)(Baseline,12 and 26 weeks follow-up)
- Montreal Cognitive Assessment (MoCA)(Baseline)
- Patient health questionnaire (PHQ-9)(Baseline,12 and 26 weeks follow-up)
- The Stroke Specific Quality of Life Scale (SS-QOL)(Baseline,12 and 26 weeks follow-up)
- Timed Up & Go (TUG) test(Baseline,12 and 26 weeks follow-up)
- Glycated hemoglobin (HbA1c)(Baseline,6,12 and 26 weeks follow-up)
研究者
Stefan Sjørslev Bodilsen
Ph.d. student, MSPT, PT
Zealand University Hospital