Brain IschemiaNCT07861009
Functional Outcomes in Patients With Cerebral Infarction After Aquatic Physiotherapy and Aerobic Exercise
A study testing Aquatic physiotherapy and Aerobic exercises in people with Brain Ischemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The aim of the study was to evaluate changes in functional outcomes in patients with cerebral infarction following aquatic physiotherapy and aerobic exercises during the second stage of rehabilitation. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Brain Ischemia
- What is being tested?
- Aquatic physiotherapy and Aerobic exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- Sep 2026to Sep 2028
- 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 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Muscle strength of 4-5 points, assessed using manual muscle testing.
- Ability to walk independently or with the use of an assistive device.
- Stable cardiovascular status, based on the results of a physician's examination and the participant's medical history.
- First-ever cerebral infarction.
- Participants aged 45-74 years.
- Mini-Mental State Examination (MMSE) score of 11-30 points, based on the patient's medical records and the assessment performed by psychologists working at Kulautuva Rehabilitation Hospital.
Who cannot join
- Muscle strength of less than 4 points, assessed using manual muscle testing.
- Inability to walk independently or with the use of an assistive device.
- Unstable cardiovascular status (uncontrolled arterial hypertension, angina --pectoris, cardiac arrhythmias, and other contraindications).
- Recurrent cerebral infarction.
- Participants younger than 45 years or older than 74 years.
- MMSE score below 11 points.
- Comorbidities that limit the ability to safely perform aquatic physiotherapy or aerobic exercises.
- Contraindications to aquatic physiotherapy (open wounds, skin diseases, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kotryna Burneikaitė contact
Lithuania1 site
LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
Kaunas, LT-53483
Ieva Žemaitienė, +37064822184, kulautuvos.reabilitacijos.ligonine@kaunoklinikos.lt
About this study
Official title: Changes in Functional Outcomes in Patients With Cerebral Infarction Following Aquatic Physiotherapy and Aerobic Exercise
The aim of the study was to evaluate changes in functional outcomes in patients with cerebral infarction following aquatic physiotherapy and aerobic exercises during the second stage of rehabilitation.
- Conditions
- Brain Ischemia
- Being tested
- Aquatic physiotherapy, Aerobic exercises
- Keywords
- Aerobic exercises, Ischemic stroke, Barthel index, Aquatic physiotherapy, Ten-Meter Walk Test, Six-Minute Walk Test, Thirty-Second Sit-to-Stand Test, Pittsburgh Sleep Quality Index
- Medical subject headings
- Brain Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic physiotherapyBehavioural
Aquatic physiotherapy will consist of a structured exercise program performed in water under the supervision of a physiotherapist. Each session will last 30 minutes and will be performed 3 times per week.
Aerobic exercisesBehavioural
Aerobic exercise will consist of a continuous 30-minute cyclical aerobic exercise session performed on a stationary bicycle under the supervision of a physiotherapist. The session will be performed 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic physiotherapy | Experimental | Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The first group will receive aquatic physiotherapy for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aquatic physiotherapy group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. Receives: Behavioral: Aquatic physiotherapy |
| Aerobic exercises | Experimental | Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The second group will receive aerobic exercise for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aerobic exercise group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. Receives: Behavioral: Aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirty-Second Sit-to-Stand Test
The Thirty-Second Sit-to-Stand Test will be used to assess lower-extremity muscle strength by measuring the number of complete sit-to-stand repetitions performed in thirty seconds. Minimum 0 repetitions, no fixed maximum; higher scores indicate better lower-extremity functional strength.
Measured: Before and after 3 weeks of rehabilitation
Six-Minute Walk Test
The Six-Minute Walk Test will be used to assess functional exercise capacity by measuring the distance walked during six minutes. Six-Minute Walk Test: minimum 0 meters, no fixed maximum; greater distances indicate better walking endurance.
Measured: Before and after 3 weeks of rehabilitation
Ten-Meter Walk Test
The Ten-Meter Walk Test will be used to assess walking speed by measuring the time required to walk ten meters. Minimum 0 seconds, no fixed maximum; lower completion times indicate better walking performance.
Measured: Before and after 3 weeks of rehabilitation
Secondary outcomes (5)
Barthel Index
The Barthel Index will be used to assess the patient's independence in activities of daily living. Minimum 0, maximum 100; higher scores indicate greater independence in activities of daily living.
Measured: Before and after 3 weeks of rehabilitation
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index will be used to assess the patient's sleep quality and sleep disturbances. Minimum 0, maximum 21; higher scores indicate worse sleep quality.
Measured: Before and after 3 weeks of rehabilitation
Systolic Blood Pressure
Systolic blood pressure will be measured to assess the cardiovascular response to physical exercise. Measured in millimeters of mercury (mmHg); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context.
Measured: Before and after 3 weeks of rehabilitation
Diastolic Blood Pressure
Diastolic blood pressure will be measured to assess the cardiovascular response to physical exercise. Measured in millimeters of mercury (mmHg); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context.
Measured: Before and after 3 weeks of rehabilitation
Heart Rate Measurement
Heart rate will be measured to assess the cardiovascular response to physical exercise. Heart rate measured in beats per minute (bpm); no fixed minimum or maximum values; higher or lower values are not inherently better or worse, as interpretation depends on the clinical context.
Measured: Before and after 3 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ieva Žemaitienė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861009
- Sponsor's protocol ID
- BE-2-65/2026
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded, de-identified individual participant data collected before and after the intervention will be shared, including results of the 6-Minute Walk Test, 10-Meter Walk Test, 30-Second Sit-to-Stand Test, Barthel Index, Sleep Quality Index questionnaire, as well as blood pressure and heart rate measurements.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Functional Outcomes in Patients With Cerebral Infarction Following Aquatic Physiotherapy and Aerobic Exercise
- ClinicalTrials.gov ID
- NCT07861009
- Acronym / sponsor ID
- BE-2-65/2026
- Conditions
- Brain Ischemia
- Keywords
- Aerobic exercises, Ischemic stroke, Barthel index, Aquatic physiotherapy, Ten-Meter Walk Test, Six-Minute Walk Test, Thirty-Second Sit-to-Stand Test, Pittsburgh Sleep Quality Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 6 Oct 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.
The aim of the study was to evaluate changes in functional outcomes in patients with cerebral infarction following aquatic physiotherapy and aerobic exercises during the second stage of rehabilitation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic physiotherapy | Experimental | Behavioral: Aquatic physiotherapyParticipants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The first group will receive aquatic physiotherapy for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aquatic physiotherapy group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. |
| Aerobic exercises | Experimental | Behavioral: Aerobic exercisesParticipants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The second group will receive aerobic exercise for 30 minutes, 3 times per week, in addition to conventional physiotherapy for 60 minutes, 5 times per week. Participants will be allocated to the aerobic exercise group using randomization to minimize selection bias and ensure comparable distribution of participants between the two groups. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Muscle strength of 4-5 points, assessed using manual muscle testing.
- Ability to walk independently or with the use of an assistive device.
- Stable cardiovascular status, based on the results of a physician's examination and the participant's medical history.
- First-ever cerebral infarction.
- Participants aged 45-74 years.
Key exclusion criteria (8 listed)
- Muscle strength of less than 4 points, assessed using manual muscle testing.
- Inability to walk independently or with the use of an assistive device.
- Unstable cardiovascular status (uncontrolled arterial hypertension, angina --pectoris, cardiac arrhythmias, and other contraindications).
- Recurrent cerebral infarction.
- Participants younger than 45 years or older than 74 years.
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 |
|---|---|---|
| Aquatic physiotherapyAquatic physiotherapy will consist of a structured exercise program performed in water under the supervision of a physiotherapist. Each session will last 30 minutes and will be performed 3 times per week. | Behavioural | Aquatic physiotherapy |
| Aerobic exercisesAerobic exercise will consist of a continuous 30-minute cyclical aerobic exercise session performed on a stationary bicycle under the supervision of a physiotherapist. The session will be performed 3 times per week. | Behavioural | Aerobic exercises |
Primary outcome
Thirty-Second Sit-to-Stand Test
Time frame: Before and after 3 weeks of rehabilitation
The Thirty-Second Sit-to-Stand Test will be used to assess lower-extremity muscle strength by measuring the number of complete sit-to-stand repetitions performed in thirty seconds. Minimum 0 repetitions, no fixed maximum; higher scores indicate better lower-extremity functional strength.
Six-Minute Walk Test
Time frame: Before and after 3 weeks of rehabilitation
The Six-Minute Walk Test will be used to assess functional exercise capacity by measuring the distance walked during six minutes. Six-Minute Walk Test: minimum 0 meters, no fixed maximum; greater distances indicate better walking endurance.
Ten-Meter Walk Test
Time frame: Before and after 3 weeks of rehabilitation
The Ten-Meter Walk Test will be used to assess walking speed by measuring the time required to walk ten meters. Minimum 0 seconds, no fixed maximum; lower completion times indicate better walking performance.
5 secondary outcomes
Barthel Index
Time frame: Before and after 3 weeks of rehabilitation
Pittsburgh Sleep Quality Index
Time frame: Before and after 3 weeks of rehabilitation
Systolic Blood Pressure
Time frame: Before and after 3 weeks of rehabilitation
Diastolic Blood Pressure
Time frame: Before and after 3 weeks of rehabilitation
Heart Rate Measurement
Time frame: Before and after 3 weeks of rehabilitation
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Coded, de-identified individual participant data collected before and after the intervention will be shared, including results of the 6-Minute Walk Test, 10-Meter Walk Test, 30-Second Sit-to-Stand Test, Barthel Index, Sleep Quality Index questionnaire, as well as blood pressure and heart rate measurements.
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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.
Kotryna Burneikaitė contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic physiotherapy and Aerobic exercises in people with Brain Ischemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 8 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: opening soon, as of the sponsor's last update on 8 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 Lithuania. 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 Ieva Žemaitienė (+37064822184, ieva.zemaitien@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirty-Second Sit-to-Stand Test (time frame: Before and after 3 weeks of rehabilitation). 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?
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 8 Oct 2026.