Effects of Sms-guided Outdoor Walking and Strength Training After Acute Stroke and TIA - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 6 minute walk test (6MWT)
研究概览
简要总结
Eighty community-living individuals in Uppsala municipality will be included. Intervention: Outdoor walking exercise program and one strength exercise. Methods: Clinical assessments, questionnaires and medical records. Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity, mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be documented.
详细描述
Eighty community-living individuals in Uppsala municipality will be included in a randomized controlled trial with two arms.
Intervention: Participants will perform an outdoor walking exercise program together with one strength exercise for 12 weeks. The intensity and frequency of the training will progressively increase. Participants are supposed to walk and perform strength training 5-7 days/week.
Methods: Clinical assessments, questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.
Assessment of motor function, cognition, level of physical activity, food intake and perceived stress are performed at screening as baseline measurements. Walking capacity (primary outcome measure), mobility, handgrip strength, body composition and cardiovascular risk markers will be assessed at baseline and after 12 week of training. At one year after training health-related quality of life, another cardiovascular incidence and mortality will be evaluated.
Power analysis is performed. The investigators will analyze the data using an intention-to -treat analysis. Participants should have participated in at least 50% of the training sessions
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verified ischemic cerebral infarction or intracerebral hemorrhage.
- •Sufficient walking capacity and motor function
- •Able to communicate in Swedish
- •Signed consent
排除标准
- •One or more of the following:
- •Subarachnoid bleeding
- •Insufficient cognition and impaired ability to understand instructions
- •Medical problems that make it unsuitable to participate
- •Pacemaker (body composition measurements)
研究组 & 干预措施
Intervention:
Outdoor walking and strength exercise, Three months, daily SMS.
干预措施: Outdoor walking and strength exercise (Other)
Control group
Usual care; no restriction for exercise, Three months
干预措施: control group (Other)
结局指标
主要结局
6 minute walk test (6MWT)
时间窗: from baseline walking capacity to three months
walking capacity
次要结局
- Short Physical Performance Battery (SPPB)(from baseline SPPB to three months)
- Montreal outcome assessment (MoCA)(at baseline)
- Mortality(from baseline to 1 year)
- Cardiometabolic risk markers(from baseline cardiometabolic risk markers to three months)
- Heart and lung foundation stress test(at baseline)
- Modified rankin scale (MRS)(at baseline)
- 10 meter walk test (10mWT)(from baseline 10mWT to three months)
- Hand-dynamometer (Jamar)(from baseline Jamar to three months)
- Body composition (bioelectric impedance analysis)(from baseline body composition to three months)
- Food frequency questionnaire(at baseline)
- Health-related quality of life(from baseline to 1 year)
研究者
Birgit Vahlberg
Md Dr, RPT
Uppsala County Council, Sweden