The Feasibility of LVHIIT on Inpatient Stroke Rehab

NCT06998017 | Not Yet Recruiting Early Phase 1

• 1 other identifier: STUDY00160192
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

High Intensity Interval Training; Stroke; Aerobic Fitness; Physical Therapy

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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).

  2-3 months

Study Arms (1)

Low-Volume High Intensity Interval Training

EXPERIMENTAL

This is the only arm in the study as it is a feasibility trial.

Other: Low Volume High Intensity Interval Training

Interventions

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.

Low-Volume High Intensity Interval Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexandra Arickx, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Wingard, DO

CONTACT

5129250447; Awingard@kumc.edu

Alexandra Arickx, MD

CONTACT

9135886796; aarickx@kumc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: May 31, 2025
• Study Start: April 13, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04