The Feasibility of LVHIIT on Inpatient Stroke Rehab
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
-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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Low Volume High Intensity Interval Training
Other interventionParticipants will conduct aerobic exercise on a total body recumbent stepper to get their heart rates to levels consistent with high intensity exercise.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Low-Volume High Intensity Interval TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
2-3 months2
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.
Time frame
2-3 months3
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.
Time frame
2-3 months4
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).
Time frame
2-3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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