THERAPEUTIC EXERCISE FOR PATIENTS WITH STROKE

NCT07736794 | Not Yet Recruiting

• 1 other identifier: EinterStroke
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

EINTER; EXERCISE; THERAPEUTIC; STROKE

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline assessment and final assessment, up to 4 weeks after the start of the programme or at hospital discharge, whichever occurs first.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Group Einter

EINTER Therapeutic Exercise in Patients with Stroke

Other: EINTER,Therapeutic exercise

Interventions

EINTER,Therapeutic exercise OTHER

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.

Group Einter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients of both sexes who have been diagnosed with stroke and admitted to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza. Participants must have sufficient clinical, cognitive, and functional capacity to safely undertake the EINTER programme, agree to participate in the study, and have both baseline and final assessments available.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Miguel Servet Hospital

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (5)

• Stroke Foundation - Australia. Clinical guidelines [Internet]. 2025. Disponible en: https://strokefoundation.org.au/

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• National Clinical Guideline for Stroke. [Internet]. 2025. Disponible en: https://www.strokeguideline.org/

  BACKGROUND

• - 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

  BACKGROUND

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Yolanda Marcen, PhD

CONTACT

0034630637923; yomarcen@unizar.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)