Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

People living with stroke have very low aerobic fitness, which can negatively impact brain health. Identifying the best exercise which includes exercise stimulus type (interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit aerobic fitness, vascular health, and the brain's main blood vessels after stroke are unknown. This study is designed to determine the preliminary efficacy of high-volume HIIT to moderate intensity exercise using a seated stepper exercise device that allows the arms and legs to move back and forth.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 85
Healthy Volunteers: f
View:

• Both sexes between the age of 20-85 years at time of consent

• Chronic ischemic or hemorrhagic stroke 6 months to 15 years 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.

• Ability to walk over ground with assistive devices and no continuous physical assistance from another person to perform tests for gait speed and six-minute walk test

• Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test.

• No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test.

• Able to communicate with investigators, follow 2-step command \& correctly answer consent comprehension questions

• Currently participating in less than 150 minutes of physical activity/week assessed by the Rapid Assessment of Physical Activity

• Stable blood pressure \& statin medication doses for 30 days prior to enrollment due to effects on vascular health/hemodynamics

Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Sandra A Billinger, PhD
sbillinger@kumc.edu
913-945-6685
Backup
Sasha Moores
smoores@kumc.edu
913-588-2697
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Active_comparator: Moderate intensity, continuous training (MICT)
After a 5-minute warm-up at 30% peak watts, MICT will consist of continuous exercise for 25 minutes at 55% of peak watts (range: 45%-65%). The average heart rate for each individual session should not exceed 70% (60-70%) of HR maximum to align with current exercise recommendations for stroke. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention.
Active_comparator: High intensity, interval exercise (HIIT)
After the 5-minute warm-up at 30% peak watts, HIIT will consist of repeated 1-minute, high intensity bursts (on interval) alternated with 1-minute interval recovery (off interval) for 25 minutes. The on interval will begin at 70% of peak watts (range: 65%-95%) followed by the off interval at 10% of peak watts. The average HR for the on intervals will not exceed 85% age predicted maximum (75-85%). There will be 13 minutes of on and 12 minutes of off interval exercise. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov