StrokeEarly Phase 1NCT06998017
The Feasibility of LVHIIT on Inpatient Stroke Rehab
A Early Phase 1 study testing Low Volume High Intensity Interval Training in people with Stroke and High Intensity Interval Training, run by University of Kansas Medical Center.
Trial summary
The objective of this study is to explore the safety and feasibility of conducting low-volume, high-intensity interval training (HIIT) on a total body recumbent stepper (TBRS) in persons with stroke in an inpatient rehabilitation setting. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, High Intensity Interval Training, Aerobic Fitness
- What is being tested?
- Low Volume High Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2026to Aug 2026
- Phase
- Early Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Both sexes between the age of 18-85 years at time of consent
- Ischemic or hemorrhagic stroke at consent. People with stroke and newly diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed.
- Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test or therapist confirmation/documentation of participant's ability to use the recumbent stepper.
- No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test determined by the therapy team or inpatient physicians.
- Able to communicate with investigators, follow 2-step command \& correctly answer consent comprehension questions
Who cannot join
- Implanted pacemaker or defibrillator limiting exercise performance
- Reported pain that limits or interferes with activities of daily living and physical activity/exercise
- Acute Myocardial Infarction in the last 2 days
- Ongoing unstable Angina
- Active Endocarditis
- Symptomatic Severe Aortic Stenosis
Show all 13Show fewer
- Decompensated Heart Failure
- Acute Pulmonary Embolism, Pulmonary Insufficiency, or Deep Veinous Thrombosis
- Acute Myocarditis or Pericarditis
- Other significant neurologic, orthopedic, or peripheral vascular conditions that would limit exercise participation
- Oxygen-dependent chronic obstructive pulmonary disease
- Neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease)
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Feasibility of Low-Volume High Intensity Interval Training on Inpatient Stroke Rehab
The objective of this study is to explore the safety and feasibility of conducting low-volume, high-intensity interval training (HIIT) on a total body recumbent stepper (TBRS) in persons with stroke in an inpatient rehabilitation setting.
- Being tested
- Low Volume High Intensity Interval Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Volume High Intensity Interval TrainingOther
Participants will conduct aerobic exercise on a total body recumbent stepper to get their heart rates to levels consistent with high intensity exercise.
| Study group | Role | What they receive |
|---|---|---|
| Low-Volume High Intensity Interval Training | Experimental | This is the only arm in the study as it is a feasibility trial. Receives: Other: Low Volume High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Treatment related adverse events will be defined as the presence of study-related cardiac or serious adverse events. The Investigators hypothesize that low-volume, short-interval, TBRS HIIT will have no incidents of treatment related adverse events in participants with subacute stroke while admitted to inpatient rehabilitation during HIIT (H1a) and within the 30 minutes following HIIT cessation (H1b).
Measured: 2-3 months
Adherence of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Feasibility will be assessed by adherence to the exercise session, attainment of target heart rates, and acceptability of the exercise. Adherence will measured by ≥ 75% of participants complete the entire 10-minute HIIT bout (H2a). Units will be the number of participants that are able to finish the full 10 minute bout of exercise.
Measured: 2-3 months
Attainment of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Feasibility will be assessed by adherence to the exercise session, attainment of target heart rates, and acceptability of the exercise. Attainment will be measured by ≥75% of participants will reach target heart rates (75%-85% max HR) during ≥75% of the high-intensity intervals (H2b). Heart rates will be measured in beats per minute. HR max will be calculated using an algorithm that adjusts for age, or beta blocker use. Units will be the number of participants reaching target HR.
Measured: 2-3 months
Acceptability of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Feasibility will be assessed by adherence to the exercise session, attainment of target heart rates, and acceptability of the exercise. To examine acceptability, the valid and reliable 8-item Physical Activity Enjoyment Scale (PACES-8) will be used, where higher scores indicate greater exercise enjoyment (H2c).
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start13 Apr 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 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.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Arickx, MD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998017
- Sponsor's protocol ID
- STUDY00160192
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Low-Volume High Intensity Interval Training on Inpatient Stroke Rehab
- ClinicalTrials.gov ID
- NCT06998017
- Acronym / sponsor ID
- STUDY00160192
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 31 May 2025 (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 objective of this study is to explore the safety and feasibility of conducting low-volume, high-intensity interval training (HIIT) on a total body recumbent stepper (TBRS) in persons with stroke in an inpatient rehabilitation setting.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Volume High Intensity Interval Training | Experimental | Other: Low Volume High Intensity Interval TrainingThis is the only arm in the study as it is a feasibility trial. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -Both sexes between the age of 18-85 years at time of consent
- Ischemic or hemorrhagic stroke at consent. People with stroke and newly diagnosed cardiovascular complications had >50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed.
- Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test or therapist confirmation/documentation of participant's ability to use the recumbent stepper.
- No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test determined by the therapy team or inpatient physicians.
- Able to communicate with investigators, follow 2-step command \& correctly answer consent comprehension questions
Key exclusion criteria (13 listed)
- Implanted pacemaker or defibrillator limiting exercise performance
- Reported pain that limits or interferes with activities of daily living and physical activity/exercise
- Acute Myocardial Infarction in the last 2 days
- Ongoing unstable Angina
- Active Endocarditis
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 |
|---|---|---|
| Low Volume High Intensity Interval TrainingParticipants will conduct aerobic exercise on a total body recumbent stepper to get their heart rates to levels consistent with high intensity exercise. | Other | Low-Volume High Intensity Interval Training |
Primary outcome
Safety of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Time frame: 2-3 months
Treatment related adverse events will be defined as the presence of study-related cardiac or serious adverse events. The Investigators hypothesize that low-volume, short-interval, TBRS HIIT will have no incidents of treatment related adverse events in participants with subacute stroke while admitted to inpatient rehabilitation during HIIT (H1a) and within the 30 minutes following HIIT cessation (H1b).
Adherence of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Time frame: 2-3 months
Feasibility will be assessed by adherence to the exercise session, attainment of target heart rates, and acceptability of the exercise. Adherence will measured by ≥ 75% of participants complete the entire 10-minute HIIT bout (H2a). Units will be the number of participants that are able to finish the full 10 minute bout of exercise.
Attainment of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Time frame: 2-3 months
Feasibility will be assessed by adherence to the exercise session, attainment of target heart rates, and acceptability of the exercise. Attainment will be measured by ≥75% of participants will reach target heart rates (75%-85% max HR) during ≥75% of the high-intensity intervals (H2b). Heart rates will be measured in beats per minute. HR max will be calculated using an algorithm that adjusts for age, or beta blocker use. Units will be the number of participants reaching target HR.
Acceptability of LVHIIT (low volume high intensity interval training) on total body recumbent stepper
Time frame: 2-3 months
Feasibility will be assessed by adherence to the exercise session, attainment of target heart rates, and acceptability of the exercise. To examine acceptability, the valid and reliable 8-item Physical Activity Enjoyment Scale (PACES-8) will be used, where higher scores indicate greater exercise enjoyment (H2c).
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 15 Apr 2026.
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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.
Alexandra Arickx, MD principal investigator
University of Kansas
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low Volume High Intensity Interval Training in people with Stroke and High Intensity Interval Training, run by University of Kansas Medical Center.
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 5 inclusion and 13 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ann Wingard, DO (5129250447, Awingard@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of LVHIIT (low volume high intensity interval training) on total body recumbent stepper (time frame: 2-3 months). The study lists 4 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 15 Apr 2026.