Description of Physical and Psychosocial Problems One Year After Stroke and the Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- The Berg Balance Scale (BBS)
研究概览
简要总结
Chronic conditions such as stroke are associated with physical disability and an economic burden for the family and the society. A medical approach is often not sufficient to address the bio-psychological process of chronic disease. Behavioural medicine approaches are often needed to improve the treatment outcomes. Those approaches have often successfully been used together with physical activity to change health behaviour in inactive individuals and in pain management. In this project the combined approach of behavioural medicine principles and physical training will be tried on patients who have had a stroke one year ago where it has yet only been used scarcely. As the study focus on the individuals' ability to function and be active the primary outcome measure is disability. The aim of the study are in a randomized controlled study evaluate if a high intense functional exercise program as an group intervention under three months can influence functional, psychosocial, anthropometric and biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome variables will be analyzed:
- level of physical activity, motor function and balance
- depression and health-related quality of life
- body mass index (BMI), metabolic risk profile, inflammation status
- number of falls, fall-related self-efficacy and outcome expectations
详细描述
Hife include functional exercises consisting of everyday tasks challenging leg strength, postural stability, and gait ability. All exercise shall be performed in weight-bearing positions, eg squats and walking over obstacles. HIFE are performed twice a week during 1 h. for three months in a group with 6-7 seven patients with stroke. Two physiotherapists lead the group and one physiotherapist select exercises for each participant according to their functional deficits. The exercises will be progressively increased in load and difficulty.
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
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with first-ever stroke in the age of 65-65 years getting their stroke at least one year ago and living in the community.
排除标准
- •Other illness or disability that have an impact on the activity level and participation in tests beside problems after stroke.
结局指标
主要结局
The Berg Balance Scale (BBS)
时间窗: baseline, after 3, 6 months and after 1 year
Total score on the scale: 0-56 Points. Higher scores indicates better balance.
Short Physical Performance Battery (SPPB)
时间窗: Baseline, after 3, 6 months and after 1 year
Total score on the scale: 0-12 Points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.
次要结局
未报告次要终点
研究者
karin hellstrom
Ass Prof. RPT, Senoir lecturer
Uppsala University