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NCT Number: NCT06998017

The Feasibility of LVHIIT 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.

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Key information

Conditions

Stroke Aerobic Fitness Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders High Intensity Interval Training Nervous System Diseases Physical Therapy Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • -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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Low Volume High Intensity Interval Training

Other

Participants will conduct aerobic exercise on a total body recumbent stepper to get their heart rates to levels consistent with high intensity exercise.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Arickx, MD

CONTACT

[email protected]

9135886796

Ann Wingard, DO

CONTACT

[email protected]

5129250447

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

The Feasibility of Low-Volume High Intensity Interval Training on Inpatient Stroke Rehab

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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