EINTER PROGRAM: Intensive Therapeutic Exercise in Patients With Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Strength
研究概览
简要总结
This study consists of the implementation of a therapeutic physical exercise program in a group setting in patients with spinal cord injury admitted to the Miguel Servet University Hospital in Zaragoza. This program consists of performing strength and endurance exercises from Monday to Friday with a duration of approximately 45 minutes each session.
The groups are created in such a way that the subjects in each group are homogeneous. This homogeneity is classified according to whether or not trunk control in seated or standing position is maintained in an autonomous manner as measured by the Berg scale. Each group consists of a maximum of 4 subjects and there are a maximum of 2 groups, and 1 physiotherapist per group. Group A is for those subjects who do not maintain independent standing, but maintain trunk control while seated, and group B is for those patients who do maintain independent standing.
Prior to the start of the program, subjects are informed of the study and evaluated with a series of health indicators (scales) to measure the impact of the program at the beginning of the program and at hospital discharge. These scales are as follows:
To measure muscular strength the investigators use the Medical Research Council, and to measure aerobic endurance the investigators use the 6 Minute Walking Test for patients who can ambulate autonomously and the 6 Minutes Pushing Test for those patients who do not ambulate and move around in a wheelchair. In addition, the investigators pass a satisfaction
详细描述
Metabolic alterations in patients with spinal cord injury are associated, among others, with arterial hypertension, lipid alterations, hyperinsulinemia and glucose transport disorders, which can lead to diabetes. This may favor the appearance of obesity phenomena in this type of patients. The decrease in physical exercise can increase these complications. With an increase in the level of physical activity, caloric expenditure is increased, thus improving the transport of glucose in the blood and decreasing the processes of diabetes. In addition, movement components such as strength and endurance are improved, which provides an improvement in balance. Therefore, with this increase in physical activity the investigators facilitate the patients greater participation in their environment once they are discharged from the hospital. Within the hospital setting, time away from scheduled therapy in patients with spinal cord injury on the Neurorehabilitation ward (U.L.M.E.) constitutes the majority of their waking time when they are admitted to this ward. Studies from other hospitals show that, as a rule, this time is approximately 4 hours a day, of which only 7-10 minutes a day are devoted to moderate and vigorous physical activity. For these reasons, the investigators consider it very important to implement therapeutic exercise programs in people with neurological pathology, in this case with a diagnosis of spinal cord injury, and to verify the impact it has on strength and endurance in this population.
The main hypothesis is that training through a designed program of therapeutic physical exercise optimizes the results referred to the improvement of strength and endurance in patients with spinal cord injury admitted to the Neurorehabilitation ward (U.L.M.E) of the Miguel Servet Hospital in Zaragoza.
The secondary hypotheses are that training based on a designed program of therapeutic physical exercise is satisfactory for patients with spinal cord injury admitted to the Neurorehabilitation ward of the Miguel Servet Hospital of Zaragoza.
The objectives of this study are:
- To improve the strength of patients with spinal cord injury at the U.L.M.E.
- To improve the aerobic endurance of the patient with spinal cord injury in the U.L.M.E.
- To increase the patients adherence to physiotherapy treatments.
- To assess patient satisfaction with their participation in therapeutic physical exercise programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
As a quasi-experimental observational study, there is no masking.
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
- •Adult patients 18 years of age or older. Clinical diagnosis of spinal cord injury below C3 admitted to the Neurorehabilitation ward of the Miguel Servet University Hospital.
排除标准
- •Clinical diagnosis of spinal cord injury level at C3 with tetraplegia.
结局指标
主要结局
Strength
时间窗: From the beginning of the program up to 12 weeks
o Muscular strength measured by Medical Research Council
Resistance
时间窗: From the beginning of the program up to 12 weeks
o Aerobic endurance measured by the 6 Minute Walking Test for patients who can ambulate autonomously and the 6 Minutes Pushing Test for those patients who do not ambulate and move around in a wheelchair.
次要结局
- Adherence to the program and level of satisfaction(From the beginning of the program up to 12 weeks)