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Not yet recruiting NCT07736794

THERAPEUTIC EXERCISE FOR PATIENTS WITH STROKE

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EINTER,Therapeutic exercise.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

EINTER PROGRAMME: INTENSIVE THERAPEUTIC EXERCISE FOR PATIENTS WITH STROKE

Overview

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.

Detailed description

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

Interventions

  • Other EINTER,Therapeutic exercise
    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.

Primary outcome measures

  • Change in muscle strength assessed using the Medical Research Council scale. [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. [Time frame: Baseline assessment and final assessment, up to 4 weeks after the start of the programme or at hospital discharge, whichever occurs first.]
Secondary outcome measures (1)
  • Participant satisfaction with the EINTER programme. [Time frame: A single assessment at the end of the programme, up to 4 weeks after its initiation, or at hospital discharge.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Miguel Servet Hospital — Zaragoza

Publications

  • Stroke Foundation - Australia. Clinical guidelines [Internet]. 2025. Disponible en: https://strokefoundation.org.au/
  • Oyanagi K, Kitai T, Yoshimura Y, Yokoi Y, Ohara N, Kohara N, Sakai N, Honda A, Onishi H, Iwata K. Effect of early intensive rehabilitation on the clinical outcomes of patients with acute stroke. Geriatr Gerontol Int. 2021 Aug;21(8):623-628. doi: 10.1111/ggi.14202. Epub 2021 Jun 8. PMID 34101957
  • Garay-Sanchez A, Ferrando-Margeli M, Navarro-Segura M, Fernandez-Celaya A, Orejuela-Aparicio E, Cuenca-Zaldivar JN, Sanchez-Romero EA, Marcen-Roman Y. Impact and feasibility of a group-based therapeutic exercise program on strength and endurance in hospitalized patients with spinal cord injury: a quasi-experimental study. J Neuroeng Rehabil. 2026 Feb 16;23(1):113. doi: 10.1186/s12984-025-01845-z. PMID 41699614
  • National Clinical Guideline for Stroke. [Internet]. 2025. Disponible en: https://www.strokeguideline.org/
  • - Ministerio de Sanidad. Estrategia en Ictus del Sistema Nacional de Salud: Actualización 2024 [Internet]. Madrid: Ministerio de Sanidad; 2024. Disponible en: https://cpage.mpr.gob.es

Identifiers

NCT: NCT07736794 · EinterStroke

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗