HIT-Stroke Trial 2

Part of paid clinical trials in Newark, Delaware.

Sponsor
University of Cincinnati
Study ID
NCT06268041
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Moderate-Intensity Aerobic Training — BEHAVIORAL
    Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.
  • High-Intensity Interval Training — BEHAVIORAL
    Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.

Study Details

People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.

Key Dates

Start date
Feb 9, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Moderate-Intensity Aerobic Training
  • Experimental: High-Intensity Interval Training

Primary Outcome Measure

6-Minute Walk Test Distance [ Time Frame: Change from Baseline to 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of DelawareNewarkDelaware19713
Darcy Reisman, PT, PhD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Sasha Moores
[email protected]
913-588-2697
Sandra Billinger, PT, PhD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45267
Audrey Nicoloff
[email protected]
513-558-7487

Find similar trials in Newark, DE

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Delaware· Newark, DEUniversity of Kansas Medical Center· Kansas City, KSUniversity of Cincinnati· Cincinnati, OH

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