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.
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 To evaluate the effectiveness of a structured, group-based therapeutic exercise programme, known as EINTER, in improving muscle strength, aerobic endurance, and functional capacity in adult patients with post-stroke impairments admitted to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza. Specific objectives The specific objectives are: To analyse changes in muscle strength following participation in the EINTER programme. To assess changes in lower limb functional capacity using the 30-Second Sit-to-Stand Test. To analyse changes in aerobic endurance and walking capacity using the 2-Minute Walk Test. To determine patients' level of satisfaction with the programme. To assess the feasibility of implementing a group-based therapeutic exercise programme during hospitalisation. Study design A prospective, single-centre, quasi-experimental study with a single-group pre-post design will be conducted. All participants will receive the EINTER programme as part of their rehabilitation intervention. Assessments will be performed before the start of the programme and after completion of the intervention or at hospital discharge. There will be no random allocation or control group. Each participant will serve as their own control through comparison of the results obtained before and after the programme. Study setting The study will be conducted at the Long- and Medium-Stay Neurorehabilitation Unit of Hospital Universitario Miguel Servet in Zaragoza. The sessions will be delivered by physiotherapists from the Department of Rehabilitation in small groups of no more than four patients per physiotherapist. This arrangement is intended to ensure appropriate supervision and allow the exercises to be adapted to each participant's abilities. Participants The study population will comprise adult patients diagnosed with stroke and admitted to the Long- and Medium-Stay Neurorehabilitation Unit. Eligibility for participation in the programme will be assessed during the multidisciplinary team meeting, taking into account each patient's clinical, cognitive, and functional status, as well as the absence of contraindications to therapeutic exercise. Recruitment and sample size Potential participants will be identified among patients admitted to the Neurorehabilitation Unit. The multidisciplinary team will determine whether they meet the established criteria and whether they can safely participate in the programme. Once eligibility has been confirmed and the corresponding consent has been obtained, a baseline assessment will be conducted. The patient will subsequently begin the EINTER programme. The sample size will correspond to the number of patients who meet the inclusion criteria during the recruitment period. Based on the unit's historical admission records and the planned duration of the study, approximately 30 patients are expected to be included. As this is a single-group study, no randomisation will be performed. Intervention The EINTER programme consists of a structured, supervised, group-based therapeutic exercise intervention. It combines aerobic and strength training tailored to each patient's abilities and limitations. The maximum duration of the programme will be four weeks. However, the actual duration of participation may vary according to the length of hospital stay, clinical progression, and exercise tolerance. The sessions will be conducted in groups of up to four patients and supervised by one physiotherapist. Variables and assessments Participants will be assessed at two time points: Before starting the EINTER programme Sociodemographic and clinical variables. Muscle strength. Lower limb functional capacity. Aerobic endurance and walking capacity. At the end of the programme or at hospital discharge Muscle strength. Lower limb functional capacity. Aerobic endurance and walking capacity. Patient satisfaction. Procedure After potentially eligible patients have been identified, the multidisciplinary team will assess compliance with the inclusion criteria and determine whether participation in the programme can be undertaken safely. Once a participant has been included, sociodemographic and clinical data will be collected, and a baseline assessment will be performed using the Medical Research Council scale, the 30-Second Sit-to-Stand Test, and the 2-Minute Walk Test. The participant will then begin the EINTER programme, which comprises aerobic and strength-training sessions. The intervention will last for a maximum of four weeks and will be adapted to the participant's length of stay in the unit. At the end of the intervention or at hospital discharge, the functional assessments will be repeated. At that time, participants will also complete a satisfaction questionnaire and receive an individualised home exercise programme. The data will be entered into a database specifically designed for the study, while ensuring the confidentiality of all participants. Statistical analysis Statistical analysis will be performed using SPSS, version 26.0. First, a descriptive analysis of the sociodemographic, clinical, and functional characteristics of the sample will be conducted. Quantitative variables will be expressed as means and standard deviations when normally distributed. When the assumption of normality is not met, medians and interquartile ranges will be reported. Categorical variables will be described using absolute frequencies and percentages. The distribution of quantitative variables will be assessed using the Shapiro-Wilk test. To evaluate the effectiveness of the programme, pre-intervention and post-intervention results will be compared for the Medical Research Council scale, the 30-Second Sit-to-Stand Test, and the 2-Minute Walk Test. When variables follow a normal distribution, parametric tests for paired samples will be used. When the assumption of normality is not met, the corresponding non-parametric tests will be applied. The results of the satisfaction questionnaire will primarily be analysed using descriptive statistics. Statistical significance will be set at p \< 0.05. Limitations The main limitation of the study will be the absence of a control group. Therefore, it will not be possible to determine conclusively whether the observed changes are exclusively attributable to the EINTER programme. Spontaneous neurological recovery, conventional rehabilitation treatment, and other interventions received during hospitalisation may also influence functional outcomes. The following limitations should also be considered: Lack of randomisation. Limited sample size. Clinical and functional heterogeneity of the participants. Differences in the actual duration of the programme. Potential loss to follow-up during hospitalisation. Limited number of outcome variables. Absence of follow-up after hospital discharge. Clinical relevance The study will provide information on the outcomes of a structured therapeutic exercise programme implemented under routine clinical practice conditions. Evidence of improvements in muscle strength, aerobic endurance, and functional capacity could support the systematic implementation of group-based therapeutic exercise programmes in hospital neurorehabilitation units. Furthermore, the information obtained may be used to optimise the content and organisation of the EINTER programme and to design future studies with greater methodological rigour.
Study Type
OBSERVATIONAL
Enrollment
30
The EINTER programme consists of a structured, supervised, group-based therapeutic exercise intervention. It combines aerobic training and strength training, tailored to each patient's abilities and limitations.
Miguel Servet Hospital
Zaragoza, Zaragoza, Spain
Change in muscle strength assessed using the Medical Research Council scale.
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.
Time frame: Baseline assessment and final assessment, up to 4 weeks after the start of the programme or at hospital discharge, whichever occurs first.
Change in aerobic endurance and walking capacity assessed using the 2-Minute Walk Test.
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.
Time frame: Baseline assessment and final assessment, up to 4 weeks after the start of the programme or at hospital discharge, whichever occurs first.
Participant satisfaction with the EINTER programme.
Satisfaction with the EINTER programme will be assessed using a questionnaire administered at the end of the intervention or at hospital discharge. Responses concerning the perceived usefulness of the programme, its organisation, the group-based format, the supervision provided, and overall satisfaction will be analysed. Results will be reported using the scores established in the questionnaire, together with frequencies and percentages for each response category.
Time frame: A single assessment at the end of the programme, up to 4 weeks after its initiation, or at hospital discharge.
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