StrokeNCT07327593
Exercise Induced Hypoalgesia in Pain-free Stroke and Healthy Populations: a Cohort Study
A study testing Cardiovascular training in people with Stroke and Pain, run by Neuron, Spain at 2 sites in Spain.
Trial summary
Exercise has shown multiple beneficial effects in both healthy and post-stroke populations. One of these is the acute reduction in sensitivity to painful stimuli, called exercise-induced hypoalgesia (EIH). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Pain, Exercise Induced Hypoalgesia
- What is being tested?
- Cardiovascular training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2026to Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy cohort:
- Age > 18 years
- No neurological damage
- No medical conditions that could affect the test
- Post-stroke cohort:
- Age > 18 years
- Ischemic or hemorrhagic stroke (time since onset > 3 months)
Who cannot join
- Healthy cohort:
- Any medical condition that could affect the test (respiratory, cardiovascular, metabolic diseases, for example)
- Pain in any location, of duration > 1 week in the 3 months preceding the trial.
- Post-stroke cohort:
- Unable to participate in the test (no possibility of transfer or active pedaling)
- Medical contraindication to cardiovascular training for any reason
Show all 10Show fewer
- Inability to follow instructions or communicate sensations during training
- Other neurological pathology, cardiac pathology (unstable angina, arrhythmias, aortic or left ventricular problems, myocarditis, pericarditis), pulmonary pathology that affects the test (pulmonary embolisms, pulmonary hypertension, etc.), renal or metabolic problems (severe renal dysfunction, uncontrolled diabetes, etc.), acute infection or fever, neurosurgery within 6 weeks prior to inclusion in the study
- Pain in any location, lasting > 1 week in the 3 months prior to the trial.
- Use of beta-blockers, antidepressants, or any medication that may alter heart rate measurements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Neuron Madrid Río
Madrid, Madrid, 28045
Alejandro Herrera Rojas, Physical Therapist, +34 640944777, alejandro.herrera@lasallecampus.es
- Recruiting
Neuron Nuevos Ministerios
Madrid, Madrid
Alejandro Herrera Rojas, Physical Therapist, +34 640944777, alejandro.herrera@lasallecampus.es
About this study
Exercise has shown multiple beneficial effects in both healthy and post-stroke populations. One of these is the acute reduction in sensitivity to painful stimuli, called exercise-induced hypoalgesia (EIH). This phenomenon has been studied since 1979 and has shown improvements in pain thresholds with both aerobic and resistance training in healthy, pain-free populations and different chronic pain conditions.
Although there has been extensive research on EIH in healthy populations and those with chronic musculoskeletal pain, surprisingly little attention has been given to individuals with neurological pathologies. Chronic pain is found in more than 50% of patients after stroke, and 70% of affected individuals experience pain on daily activities. Reported prevalences of post-stroke pain (PSP) between different studies, but there is a general consensus that it is an underreported phenomenon. Patients with pain experience greater cognitive and functional decline, fatigue, depression and lower quality of life.
Multiple factors contribute to PSP, and various approaches exist to treat all the variables influencing it. This study aims to compare the effects of exercise on pain perception in healthy individuals and stroke patients without pain, using the same cardiovascular training protocol, to better understand the mechanisms of EIH and its maintenance after stroke, ultimately aiming to improve the treatment of people with stroke.
- Conditions
- Stroke, Pain, Exercise Induced Hypoalgesia
- Being tested
- Cardiovascular training
- Keywords
- Stroke, Pain, Exercise induced hypoalgesia, Cardiovascular training
- Medical subject headings
- Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular trainingOther
The cardiovascular training protocol will consist of a 5-minute warm-up aimed at reaching 70% of maximum heart rate (MHR) followed by 20 minutes of sustained work at this intensity (since maintaining this intensity is difficult, especially in the stroke cohort, we will allow for a margin of ±2-3% of MHR and provide feedback to increase or decrease the heart rate). We will aim to keep the heart rate below 73% of maximum heart rate, maintain blood pressure within safe ranges, and keep the effort level between 14/20 and 16/20
| Study group | Role | What they receive |
|---|---|---|
| Healthy cohort | Active comparator | Age > 18 years; no neurological damage; no medical conditions that could affect the test; no pain of duration > 1 week in the 3 months preceding the enrollment. No serious medical conditions.
First, pressure pain thresholds and conditioned pain modulation will be assessed. Then, participants will conduct a cardiovascular training for 30 minutes, and will be reassessed inmediately post-training and 30 minutes after. Receives: Other: Cardiovascular training |
| Post-stroke pain free cohort | Experimental | Ischemic or hemorrhagic stroke (> 3 months); older than 18 years old; of duration > 1 week in the 3 months preceding the enrollment. No other serious medical conditions.
Post-stroke participants will get the same study protocol than healthy cohort. Receives: Other: Cardiovascular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain thresholds
Pressure pain thresholds (PPT) are the most used pain sensitivity measure for these paradigms, and represent a static measure of pain, indicating the basal state of pain perception. It is usually measured with an algometer, which is pressured into the body of the participant, who is informed to warn in the moment when pressure starts to be painful. EIH has shown little differences between local and general effects, so we will measure PPT in both rectus femoris (local effects) and first dorsal interosseous (general effects), marking the exact points for ensuring the replicability of the measure after the exercise program. In the post-stroke cohort, this assessment will be performed on the non-paretic side, so that the possible loss of sensitivity due to the condition does not influence the measurements.
Measured: Before the cardiovacular training, inmediately after the training, and 30 minutes after
Conditioned pain modulation
Conditioned pain comulation (CPM) is the terminology used to describe the effect of endogenous pathways to enhance or diminish the afferent noxious stimuli. For this assessment the "cuff test" methodology will be carried out over the healthy arm of post-stroke participants. This methodology employs a test stimulus (TS) using pressure pain threshold measurement. Subsequently, an inflatable pressure cuff is applied, and its pressure is increased until the patient reports a pain sensation of 6 out of 10. While the cuff is inflated, the pressure pain threshold measurement is repeated to obtain a a conditioned stimulus (CS). The test result is then calculated by subtracting the pressures obtained on the algometer, thus calculating the CS-TS difference.
CPM will be measured in the dominant side in the healthy cohort and in the healthy side in the post-stroke cohort.
Measured: Before the cardiovascular training, inmediately after the training and 30 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups will be created (healthy and post-stroke). Both will carry out the same evaluation and exercise protocol to study the differences between both cohorts
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuron, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Herrera Rojas, Physical Therapist, Principal investigator, Neuron, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327593
- Sponsor's protocol ID
- NeuronRehab
- Status last verified
- Mar 2026
- First submitted
- 26 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All used databases (anonymized data) will be uploaded into zenodo
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Induced Hypoalgesia in Pain-free Stroke and Healthy Populations: a Cohort Study
- ClinicalTrials.gov ID
- NCT07327593
- Acronym / sponsor ID
- NeuronRehab
- Conditions
- Stroke, Pain, Exercise Induced Hypoalgesia
- Keywords
- Stroke, Pain, Exercise induced hypoalgesia, Cardiovascular training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Neuron, SpainUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise has shown multiple beneficial effects in both healthy and post-stroke populations. One of these is the acute reduction in sensitivity to painful stimuli, called exercise-induced hypoalgesia (EIH). This phenomenon has been studied since 1979 and has shown improvements in pain thresholds with both aerobic and resistance training in healthy, pain-free populations and different chronic pain conditions.
Although there has been extensive research on EIH in healthy populations and those with chronic musculoskeletal pain, surprisingly little attention has been given to individuals with neurological pathologies. Chronic pain is found in more than 50% of patients after stroke, and 70% of affected individuals experience pain on daily activities. Reported prevalences of post-stroke pain (PSP) between different studies, but there is a general consensus that it is an underreported phenomenon. Patients with pain experience greater cognitive and functional decline, fatigue, depression and lower quality of life.
Multiple factors contribute to PSP, and various approaches exist to treat all the variables influencing it. This study aims to compare the effects of exercise on pain perception in healthy individuals and stroke patients without pain, using the same cardiovascular training protocol, to better understand the mechanisms of EIH and its maintenance after stroke, ultimately aiming to improve the treatment of people with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups will be created (healthy and post-stroke). Both will carry out the same evaluation and exercise protocol to study the differences between both cohorts
| Arm | Type | Receives |
|---|---|---|
| Healthy cohort | Active comparator | Other: Cardiovascular trainingAge > 18 years; no neurological damage; no medical conditions that could affect the test; no pain of duration > 1 week in the 3 months preceding the enrollment. No serious medical conditions. First, pressure pain thresholds and conditioned pain modulation will be assessed. Then, participants will conduct a cardiovascular training for 30 minutes, and will be reassessed inmediately post-training and 30 minutes after. |
| Post-stroke pain free cohort | Experimental | Other: Cardiovascular trainingIschemic or hemorrhagic stroke (> 3 months); older than 18 years old; of duration > 1 week in the 3 months preceding the enrollment. No other serious medical conditions. Post-stroke participants will get the same study protocol than healthy cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- No neurological damage
- No medical conditions that could affect the test
- Age > 18 years
- Ischemic or hemorrhagic stroke (time since onset > 3 months)
Key exclusion criteria (10 listed)
- Any medical condition that could affect the test (respiratory, cardiovascular, metabolic diseases, for example)
- Pain in any location, of duration > 1 week in the 3 months preceding the trial.
- Unable to participate in the test (no possibility of transfer or active pedaling)
- Medical contraindication to cardiovascular training for any reason
- Inability to follow instructions or communicate sensations during training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular trainingThe cardiovascular training protocol will consist of a 5-minute warm-up aimed at reaching 70% of maximum heart rate (MHR) followed by 20 minutes of sustained work at this intensity (since maintaining this intensity is difficult, especially in the stroke cohort, we will allow for a margin of ±2-3% of MHR and provide feedback to increase or decrease the heart rate). We will aim to keep the heart rate below 73% of maximum heart rate, maintain blood pressure within safe ranges, and keep the effort level between 14/20 and 16/20 | Other | Healthy cohort, Post-stroke pain free cohort |
Primary outcome
Pressure pain thresholds
Time frame: Before the cardiovacular training, inmediately after the training, and 30 minutes after
Pressure pain thresholds (PPT) are the most used pain sensitivity measure for these paradigms, and represent a static measure of pain, indicating the basal state of pain perception. It is usually measured with an algometer, which is pressured into the body of the participant, who is informed to warn in the moment when pressure starts to be painful. EIH has shown little differences between local and general effects, so we will measure PPT in both rectus femoris (local effects) and first dorsal interosseous (general effects), marking the exact points for ensuring the replicability of the measure after the exercise program. In the post-stroke cohort, this assessment will be performed on the non-paretic side, so that the possible loss of sensitivity due to the condition does not influence the measurements.
Conditioned pain modulation
Time frame: Before the cardiovascular training, inmediately after the training and 30 minutes after
Conditioned pain comulation (CPM) is the terminology used to describe the effect of endogenous pathways to enhance or diminish the afferent noxious stimuli. For this assessment the "cuff test" methodology will be carried out over the healthy arm of post-stroke participants. This methodology employs a test stimulus (TS) using pressure pain threshold measurement. Subsequently, an inflatable pressure cuff is applied, and its pressure is increased until the patient reports a pain sensation of 6 out of 10. While the cuff is inflated, the pressure pain threshold measurement is repeated to obtain a a conditioned stimulus (CS). The test result is then calculated by subtracting the pressures obtained on the algometer, thus calculating the CS-TS difference. CPM will be measured in the dominant side in the healthy cohort and in the healthy side in the post-stroke cohort.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. All used databases (anonymized data) will be uploaded into zenodo
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Herrera Rojas, Physical Therapist principal investigator
Neuron, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular training in people with Stroke and Pain, run by Neuron, Spain at 2 sites 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Alejandro Herrera Rojas, Physical Therapist (+ 34 640944777, aherrerar2003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain thresholds (time frame: Before the cardiovacular training, inmediately after the training, and 30 minutes after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.