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StrokeEINTERNCT07736794

Therapeutic Exercise for Patients With Stroke

A study testing EINTER Therapeutic Exercise Programme in people with Stroke, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this prospective, single-centre, non-randomized, single-arm interventional study is to evaluate changes in muscle strength, lower-limb functional capacity, aerobic endurance, and patient satisfaction following participation in the EINTER group-based therapeutic exercise programme in adults with post-stroke… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
EINTER Therapeutic Exercise Programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteSpain
Study dates
3 Aug 2026to 15 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Confirmed diagnosis of stroke.
  • Admission to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet.
  • Sufficient clinical, cognitive, and functional capacity to participate safely in the EINTER therapeutic exercise programme, as assessed by the multidisciplinary clinical team.
  • Ability to understand and follow the instructions required to perform the therapeutic exercise programme and study assessments, with appropriate communication support when needed.
  • Provision of informed consent to participate in the study.

Who cannot join

  • Presence of a medical or clinical contraindication to therapeutic exercise.
  • Clinical instability that prevents safe participation in the intervention.
  • Severe cognitive, behavioural, communication, or functional impairment that prevents safe participation in the programme or completion of the required study procedures, as determined by the multidisciplinary clinical team.
  • Any other clinical condition considered by the treating team to make participation in the EINTER programme unsafe.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: EINTER Programme: Intensive Therapeutic Exercise for Patients With Stroke

The aim of this prospective, single-centre, non-randomized, single-arm interventional study is to evaluate changes in muscle strength, lower-limb functional capacity, aerobic endurance, and patient satisfaction following participation in the EINTER group-based therapeutic exercise programme in adults with post-stroke impairments admitted to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza, Spain.

Participants will be assigned to receive the EINTER programme during their hospital stay. The programme combines supervised aerobic and progressive strength training and is delivered in small groups of up to four patients per physiotherapist for a maximum of four weeks.

Read more

Functional assessments will be performed before starting the programme and after completion of the intervention or at hospital discharge. Muscle strength will be assessed using the Medical Research Council scale, lower-limb functional capacity using the 30-Second Sit-to-Stand Test, and aerobic endurance and walking capacity using the 2-Minute Walk Test. Participant satisfaction will also be assessed at the end of the programme.

There will be no control group or random allocation. Changes in outcomes will therefore be evaluated using within-participant pre-post comparisons.

Read the detailed description

Stroke is a leading cause of acquired disability in adults and is frequently associated with reduced muscle strength, impaired walking capacity, decreased aerobic endurance, and limitations in transfers and other functional activities. During hospitalisation, these impairments may be further influenced by reduced physical activity, immobility, and cardiorespiratory deconditioning.

The EINTER programme is a structured, supervised, group-based therapeutic exercise intervention designed for adults with post-stroke impairments admitted to the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza, Spain. The programme combines aerobic and progressive strength training tailored to each participant's clinical and functional status and is supervised by physiotherapists.

Study objective The primary objective is to evaluate changes in muscle strength, lower-limb functional capacity, and aerobic endurance following participation in the EINTER programme. The secondary objective is to assess participant satisfaction with the EINTER programme.

Study design This is a prospective, single-centre, non-randomized, single-arm interventional study with a pre-post design. Eligible participants will be assigned to receive the EINTER programme. No control group or random allocation will be used. Outcomes will be assessed before the start of the intervention and after completion of the programme or at hospital discharge.

Study setting and participants The study will be conducted in the Long- and Medium-Stay Neurorehabilitation Unit at Hospital Universitario Miguel Servet in Zaragoza. Adult patients with a confirmed diagnosis of stroke who meet the predefined eligibility criteria and are considered clinically able to participate safely in therapeutic exercise will be considered for inclusion.

Potential participants will be identified among patients admitted to the Neurorehabilitation Unit. Eligibility will be assessed by the multidisciplinary clinical team. After informed consent and completion of the baseline assessment, participants will begin the EINTER programme.

Approximately 35 participants are expected to be enrolled during the recruitment period.

Intervention The EINTER programme consists of supervised aerobic and strength-training sessions delivered in small groups of up to four patients per physiotherapist. Aerobic training will be performed on a stationary bicycle twice per week, while progressive strength training will be performed three times per week. Exercise intensity and progression will be adapted to each participant's abilities, clinical condition, and exercise tolerance.

The maximum duration of participation will be four weeks, although the actual duration may vary according to the participant's length of hospital stay and clinical progression.

Assessments Participants will be assessed at baseline, before starting the EINTER programme, and at the end of the intervention or at hospital discharge.

The assessments will include:

  • muscle strength measured using the Medical Research Council scale;
  • lower-limb functional capacity measured using the 30-Second Sit-to-Stand Test;
  • aerobic endurance and walking capacity measured using the 2-Minute Walk Test; and
  • participant satisfaction assessed at the end of the programme. The principal analysis will examine within-participant changes between baseline and post-intervention assessments. Because the study does not include a concurrent control group, observed changes will be interpreted with consideration of potential influences such as spontaneous neurological recovery and concomitant rehabilitation received during hospitalisation.
Conditions
Stroke
Being tested
EINTER Therapeutic Exercise Programme
Keywords
Einter, Exercise, Therapeutic, Stroke, Stroke Rehabilitation, Neurorehabilitation, Aerobic Exercise, Strength Training, Group-Based Exercise, Functional Capacity
Medical subject headings
Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EINTER Therapeutic Exercise ProgrammeOther

    The EINTER programme is a structured, supervised, group-based therapeutic exercise intervention for adults with post-stroke impairments. It combines aerobic training on a stationary bicycle twice per week with progressive strength training three times per week. Exercise intensity and progression are individualized according to each participant's clinical status, functional capacity, and exercise tolerance. The intervention is delivered in groups of up to four participants per physiotherapist for a maximum of four weeks or until hospital discharge, whichever occurs first.

Study groups in NCT07736794
Study groupRoleWhat they receive
EINTER Therapeutic ExerciseExperimentalParticipants assigned to this arm receive the EINTER therapeutic exercise programme, a structured, supervised, group-based intervention combining aerobic and progressive strength training. Aerobic training is performed on a stationary bicycle twice per week and progressive strength training three times per week. Sessions are delivered in groups of up to four participants per physiotherapist and are individualized according to each participant's clinical and functional status. The programme lasts for a maximum of four weeks or until hospital discharge, whichever occurs first.
Receives: Other: EINTER Therapeutic Exercise Programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Muscle Strength Assessed Using the Medical Research Council Scale

    Muscle strength will be assessed using the Medical Research Council (MRC) scale. Each muscle group is graded from 0 (no visible muscle contraction) to 5 (normal strength against resistance), with higher scores indicating greater muscle strength. The change between baseline, before starting the EINTER programme, and the final assessment after completion of the intervention or at hospital discharge will be analysed.

    Measured: Baseline and final assessment, up to 4 weeks after starting the intervention or at hospital discharge, whichever occurs first.

  2. 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 (2MWT). The outcome is the total distance walked, measured in metres, during two minutes. The distance recorded at baseline will be compared with that recorded after completion of the EINTER programme or at hospital discharge. A greater distance indicates better aerobic endurance and walking capacity.

    Measured: Baseline and final assessment, up to 4 weeks after starting the intervention or at hospital discharge, whichever occurs first.

  3. Change in Lower-Limb Functional Capacity Assessed Using the 30-Second Sit-to-Stand Test

    Lower-limb functional capacity will be assessed using the 30-Second Sit-to-Stand Test (30s-STS). The outcome is the total number of complete sit-to-stand repetitions performed within 30 seconds. The number of repetitions recorded at baseline will be compared with that recorded after completion of the EINTER programme or at hospital discharge. A greater number of completed repetitions indicates better lower-limb functional capacity.

    Measured: Baseline and final assessment, up to 4 weeks after starting the intervention or at hospital discharge, whichever occurs first.

Secondary outcomes (1)
  1. Participant Satisfaction With the EINTER Programme

    Participant satisfaction with the EINTER programme will be assessed using an ad hoc six-item questionnaire administered at the end of the intervention or at hospital discharge. Each item is rated on a 5-point Likert scale: 1 = Completely false, 2 = False, 3 = Neither true nor false, 4 = True, and 5 = Completely true. Higher scores indicate a more favourable assessment of the programme. The questionnaire evaluates the individualisation of strength exercises, session duration, programme duration, availability of equipment, physiotherapist care, and overall satisfaction. Individual item responses will be summarized using descriptive statistics and response frequencies.

    Measured: Single assessment at the end of the intervention, up to 4 weeks after starting the programme or at hospital discharge, whichever occurs first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start3 Aug 2026
  3. Primary completion1 Oct 2026
  4. Study completion15 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, single-centre, single-arm interventional study with a pre-post design. All participants receive the EINTER therapeutic exercise programme as part of the study protocol. Outcomes are assessed at baseline, before starting the intervention, and again after completion of the programme or at hospital discharge. No concurrent control group or random allocation is used.
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07736794
Sponsor's protocol ID
EinterStroke
Acronym
EINTER
Status last verified
Oct 2026
First submitted
26 Jul 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to the small, single-centre sample and the risk of participant re-identification.

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.

    PubMed 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.

    PubMed 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

Questions about this trial

What is this clinical trial studying?

A study testing EINTER Therapeutic Exercise Programme in people with Stroke, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Muscle Strength Assessed Using the Medical Research Council Scale (time frame: Baseline and final assessment, up to 4 weeks after starting the intervention or at hospital discharge, whichever occurs first.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07736794, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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