EINTER PROGRAMME: INTENSIVE THERAPEUTIC EXERCISE FOR PATIENTS WITH STROKE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in muscle strength assessed using the Medical Research Council scale.
研究概览
简要总结
The aim of this observational study, using a quasi-experimental pre-post design, is to evaluate the effectiveness of the EINTER group-based therapeutic exercise programme in improving muscle strength and aerobic endurance in adult patients with post-stroke impairments admitted to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza.
The main research questions are:
Does the EINTER programme improve patients' muscle strength, as assessed using the Medical Research Council scale and the 30-Second Sit-to-Stand Test? Does the programme improve aerobic endurance, as assessed using the 2-Minute Walk Test? Is the programme satisfactory for the participating patients?
As there will be no control group, the outcomes obtained before the start of the programme will be compared with those recorded at hospital discharge.
Approximately 30 patients aged 18 years or older who participate in the programme during their hospital stay will be included. Participants will undertake:
Aerobic training on a stationary bicycle twice per week. Progressive strength training three times per week. A group-based programme lasting up to four weeks, with a maximum of four patients per physiotherapist.
Functional assessments before and after the intervention, together with a satisfaction questionnaire administered at hospital discharge.
详细描述
Stroke is one of the leading causes of acquired disability in the adult population. Its most common consequences include reduced muscle strength, decreased aerobic endurance, gait impairments, and limitations in performing transfers and functional activities. These impairments may be further aggravated during hospitalisation by immobility, reduced physical activity, and cardiorespiratory deconditioning.
Therapeutic exercise is an important component of neurorehabilitation. The combination of aerobic training and muscle-strengthening exercise may contribute to improving functional capacity, mobility, and exercise tolerance in individuals with post-stroke impairments. Moreover, a group-based format may enhance motivation, treatment adherence, and patients' active participation.
The EINTER programme is a structured, group-based therapeutic exercise programme for patients with post-stroke impairments admitted to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza. It includes aerobic and strength training tailored to each participant's clinical and functional status and supervised by physiotherapists.
The present study aims to prospectively evaluate the effects of the EINTER programme on muscle strength, aerobic endurance, and functional capacity, as well as to assess participants' satisfaction with the programme.
General objective
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged 18 years or older.
- •Diagnosis of stroke.
- •Admission to the Neurorehabilitation Unit at Hospital Universitario Miguel Servet.
- •Sufficient clinical and functional capacity to participate in the programme, as assessed by the multidisciplinary team.
- •Agreement to participate in the study.
- •Availability of both baseline and final assessments.
排除标准
- •Age under 18 years.
- •Absence of a confirmed diagnosis of stroke.
- •Not being admitted to the Neurorehabilitation Unit at Hospital Universitario Miguel Servet.
- •Presence of a clinical condition or medical contraindication that prevents safe participation in therapeutic exercise.
- •Insufficient clinical, cognitive, behavioural, or functional capacity to understand instructions or safely complete the programme, as assessed by the multidisciplinary team.
- •Clinical instability or significant deterioration during the study period.
- •Refusal or withdrawal of consent to participate in the study.
结局指标
主要结局
Change in muscle strength assessed using the Medical Research Council scale.
时间窗: Baseline assessment and final assessment, up to 4 weeks after the start of the programme or at hospital discharge, whichever occurs first.
Muscle strength will be assessed using the Medical Research Council scale, which grades the contractile capacity of the muscle groups examined from 0-no visible muscle contraction-to 5-normal strength against resistance. The change between the score obtained before starting the EINTER programme and the score recorded at the end of the intervention or at hospital discharge will be analysed. A higher score indicates greater muscle strength.
Change in aerobic endurance and walking capacity assessed using the 2-Minute Walk Test.
时间窗: Baseline assessment and final assessment, up to 4 weeks after the start of the programme or at hospital discharge, whichever occurs first.
Aerobic endurance and walking capacity will be assessed using the 2-Minute Walk Test. The outcome measure will be the total distance, expressed in metres, that the participant is able to walk within two minutes. The distance covered before starting the EINTER programme will be compared with that recorded at the end of the intervention or at hospital discharge. A greater distance covered indicates better aerobic endurance and walking capacity.
次要结局
- Participant satisfaction with the EINTER programme.(A single assessment at the end of the programme, up to 4 weeks after its initiation, or at hospital discharge.)
研究者
Yolanda Marcen Roman
PhD
Instituto de Investigación Sanitaria Aragón