An interventional study of EINTER Therapeutic Exercise Programme in Stroke, sponsored by Instituto de Investigación Sanitaria Aragón. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Instituto de Investigación Sanitaria Aragón · Not applicable, Interventional, and Treatment
Among 321 studies in Stroke with a site in Spain — 71 open to participants now, 89 under way, 6 of them phase 3. Stroke · Spain.
Among the 321 studies in Stroke with a site in Spain, this one is the 178th largest by enrollment of the 244 interventional ones, is one of 15 that started in 2026, is one of 158 with no phase, reaches primary completion later than 43 of the 88 other live ones, and was the 312th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 35 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →71 of the 321 studies in Stroke with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →321 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 15 started in 2026.
Median enrollment 70 across the 244 interventional studies, 250 across the 77 observational. Of the 197 that completed or were terminated, 33 (17%) have results posted.
82 of 321 have an industry lead sponsor. The 10 most frequent:
Instituto de Investigación Sanitaria Aragón is the lead sponsor of 32 studies on the registry; 12 are open to participants now.
Instituto de Investigación Sanitaria Aragón has 1 study filed under Stroke — fewer than ten, so there is no comparison to draw.
25 of the studies in Stroke with a site in Spain that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT06296082Phase 3Universiteit AntwerpenComparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity | 2026-12-30 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT07357285iVascular S.L.U.Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO) | 2026-11 |
| NCT07497464Alfredo Lerín CalvoValidity of an Open-access Handedness Recognition Task in Stroke Patients | 2026-11 |
Among the 321 studies in Stroke with a site in Spain, from their registry updates:
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.
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.
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:
The criteria were revised on the registry on Oct 7, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Other: EINTER Therapeutic Exercise Programme
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.
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.
Time frame: Baseline and final assessment, up to 4 weeks after starting the intervention 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 (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.
Time frame: Baseline and final assessment, up to 4 weeks after starting the intervention or at hospital discharge, whichever occurs first.
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.
Time frame: Baseline and final assessment, up to 4 weeks after starting the intervention or at hospital discharge, whichever occurs first.
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.
Time frame: Single assessment at the end of the intervention, up to 4 weeks after starting the programme or at hospital discharge, whichever occurs first.
Plan to share: No — Individual participant data will not be shared due to the small, single-centre sample and the risk of participant re-identification.
Ran from Aug 2026 to primary completion in Oct 2026, 1 month.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 1 month is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 7, 2026: primary completion Dec 2026 → Oct 2026 and completion Feb 2027 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Sanitaria Aragón