Effect of Rehabilitation on the Body Composition in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change Body composition assessment (fat mass, visceral fat level , muscle tissue, fat free mass , water content in the body) subjected to bioelectrical impedancy analysis - Tanita 780.
研究概览
简要总结
The study enabled assessment of changes in body mass composition, metabolic syndrome and lipid profile in patients after stroke, following rehabilitation in hospital.
详细描述
Stroke is estimated to affect 24-54% of the global population and is one of the leading causes of death. According to World Health Organization over one billion people worldwide are overweight, and approximately 300 million people are obese. The main factors contributing to this situation include insufficient physical activity and unhealthy diet. Among the major consequences of obesity in adults one can distinguish metabolic syndrome and cardiovascular diseases.
Therefore, measurements were performed to identify changes in body mass composition (body fat, visceral fat level, muscle mass, total body water, metabolic syndrome, lipid profile) in subjects after stroke following rehabilitation at hospital.
The study was carried at the Clinical Rehabilitation Ward with Early Neurological Rehabilitation Unit, at the Clinical Hospital in Rzeszów, Poland. The measurements were performed from June 2015 to March 2017. During that time the total of 1,143 patients received treatment and rehabilitation at the clinic. These included 403 patients after stroke. The subjects were examined three times. In accordance with inclusion and exclusion criteria 128 subjects were qualified for the first exam. The second exam took into account 114 subjects and finally 100 patients with stroke participated in the third exam. The analyses took into account the data obtained from the 100 subjects who took part in all the exams. Body mass composition was assessed in all the subjects with Tanita MC 780 MA analyzer, whose operation is based on Bioelectrical impedance analysis (BIA). The subjects' height was measured with the stadiometer PORTSTAND 210. Rehabilitation outcome was assessed with Barthel index, Berg scale, Ashworth scale, Brunnström scale, Rankin scale and symmetry index for lower limb weight distribution (Ws).
In addition, waist and hip circumference were measured and WHR was calculated. The above parameters were assessed three times:
Exam I took place upon admission to hospital Exam II on the day the patient was discharged from hospital Exam III was performed 12 weeks after discharge from hospital during a follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Stroke experienced.
- •Ability to stand without assistance.
- •Ability to walk without aid.
- •No impairments in higher mental functions
- •Patient's informed, voluntary consent to participate in the study.
排除标准
- •Lack of patient's consent to participate in the study
- •Lack of ability to stand without assistance.
- •Ischemic lesion located in the cerebellum and brain stem.
- •Metal, electronic implants.
- •Epilepsy.
- •Pregnancy.
- •Menstruation, in females.
- •Limb injuries incurred following stroke onset, prior to the exam.
研究组 & 干预措施
Rehabilitation group
Patients with stroke receiving standard inpatient rehabilitation for five weeks
干预措施: Standard rehabilitation after stroke (Other)
结局指标
主要结局
Change Body composition assessment (fat mass, visceral fat level , muscle tissue, fat free mass , water content in the body) subjected to bioelectrical impedancy analysis - Tanita 780.
时间窗: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
Assessment of body composition (bioelectrical impedancy analysis - Tanita 780) Change from Baseline body composition at 5 weeks between baseline, after the end of protocol treatment, and 12 weeks after the end of the protocol treatment.
次要结局
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.(at baseline, immediately after treatment completion, and 12 weeks after treatment completion)
- Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.(at baseline, immediately after treatment completion, and 12 weeks after treatment completion)
- Changes in blood parameter: HDL(at 5 weeks between baseline, after the end of protocol treatment,)
- Changes in blood parameter: LDL(at 5 weeks between baseline, after the end of protocol treatment)
- Changes in blood parameter: serum glucose(at 5 weeks between baseline, after the end of protocol treatment,)
- Balance was assessed using Berg Balance Scale (BBS)(at baseline, immediately after treatment completion, and 12 weeks after treatment completion)
- Assessment of disability level, using the modified Rankin scale (MRS)(at baseline, immediately after treatment completion, and 12 weeks after treatment completion)
- Assessment of paretic limb function was assessed using the Brunnström scale.(at baseline, immediately after treatment completion, and 12 weeks after treatment completion)
- Assessment of metabolic syndrome(at 5 weeks between baseline, after the end of protocol treatment)
- Assessment of symmetry index for lower limb weight distribution(at baseline, immediately after treatment completion, and 12 weeks after treatment completion)
- Changes in blood parameter: total cholesterol(at 5 weeks between baseline, after the end of protocol treatment)
- Changes in blood parameter: TG(at 5 weeks between baseline, after the end of protocol treatment,)
- Assessment of WHR(at 5 weeks between baseline, after the end of protocol treatment, and 12 weeks after treatment completion)
- Changes in blood parameter: atherogenic index(at 5 weeks between baseline, after the end of protocol treatment,)
- Changes in blood parameter: CRP(at 5 weeks between baseline, after the end of protocol treatment,)
研究者
Justyna Leszczak
Principal Investigator
University of Rzeszow