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NCT03760016

Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke

Completed NA Results posted Last updated 26 March 2025
What this trial tests

NA trial testing Moderate-Intensity Aerobic Training in Stroke in 55 participants. Completed in 25 April 2022.

Timeline
4 January 2019
Primary endpoint
25 April 2022
25 April 2022

Quick facts

Lead sponsorUniversity of Cincinnati
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment55
Start date4 January 2019
Primary completion25 April 2022
Estimated completion25 April 2022
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Cincinnati

Who can join

Adults 40 to 80, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Six-Minute Walk Test Distance Primary · Change Six-Minute Walk Test Distance from Baseline to 4 Weeks

Total distance walked in 6 minutes in meters

GroupValue95% CI
High-Intensity Interval Training276 – 48
Moderate-Intensity Aerobic Training12-9 – 33
Six-Minute Walk Test Distance Primary · Change Six-Minute Walk Test Distance from Baseline to 8 Weeks

Total distance walked in 6 minutes in meters

GroupValue95% CI
High-Intensity Interval Training5839 – 76
Moderate-Intensity Aerobic Training299 – 48
Six-Minute Walk Test Distance Primary · Change Six-Minute Walk Test Distance from Baseline to 12 Weeks

Total distance walked in 6 minutes in meters

GroupValue95% CI
High-Intensity Interval Training7149 – 94
Moderate-Intensity Aerobic Training273 – 50
Comfortable Gait Speed Secondary · Change from Baseline to 4 Weeks

From 10-meter walk test, in meters per second

GroupValue95% CI
High-Intensity Interval Training0.110.06 – 0.15
Moderate-Intensity Aerobic Training0.02-0.02 – 0.07
Comfortable Gait Speed Secondary · Change from Baseline to 8 Weeks

From 10-meter walk test, in meters per second

GroupValue95% CI
High-Intensity Interval Training0.140.08 – 0.20
Moderate-Intensity Aerobic Training0.060.00 – 0.12
Comfortable Gait Speed Secondary · Change from Baseline to 12 Weeks

From 10-meter walk test, in meters per second

GroupValue95% CI
High-Intensity Interval Training0.190.13 – 0.25
Moderate-Intensity Aerobic Training0.060.00 – 0.12
Fast Gait Speed Secondary · Change from Baseline to 4 Weeks

From 10-meter walk test, in meters per second

GroupValue95% CI
High-Intensity Interval Training0.220.16 – 0.28
Moderate-Intensity Aerobic Training0.01-0.05 – 0.07
Fast Gait Speed Secondary · Change from Baseline to 8 Weeks

From 10-meter walk test, in meters per second

GroupValue95% CI
High-Intensity Interval Training0.240.17 – 0.32
Moderate-Intensity Aerobic Training0.090.01 – 0.17
Fast Gait Speed Secondary · Change from Baseline to 12 Weeks

From 10-meter walk test, in meters per second

GroupValue95% CI
High-Intensity Interval Training0.280.19 – 0.37
Moderate-Intensity Aerobic Training0.09-0.01 – 0.18
Aerobic Fitness Secondary · Change from Baseline to 4 Weeks

Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute

GroupValue95% CI
High-Intensity Interval Training1.30.4 – 2.2
Moderate-Intensity Aerobic Training0.4-0.5 – 1.3
Aerobic Fitness Secondary · Change from Baseline to 8 Weeks

Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute

GroupValue95% CI
High-Intensity Interval Training2.00.7 – 3.3
Moderate-Intensity Aerobic Training1.70.3 – 3.1
Aerobic Fitness Secondary · Change from Baseline to 12 Weeks

Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute

GroupValue95% CI
High-Intensity Interval Training1.90.4 – 3.4
Moderate-Intensity Aerobic Training1.4-0.2 – 3.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of participant enrollment post-randomization, which was approximately 4 months for participants who completed the study. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High-Intensity Interval Training
Serious: 1/27 (4%)
Deaths: 0/27
Moderate-Intensity Aerobic Training
Serious: 3/28 (11%)
Deaths: 0/28

Serious adverse events (4 terms)

ReactionSystemHigh-Intensity Interval Tr…Moderate-Intensity Aerobic…
seizureNervous system disorders
fall with fractureMusculoskeletal and connective tissue disorders
deliriumNervous system disorders
strokeNervous system disorders
Other adverse events (4 terms — click to expand)

ReactionSystemHigh-Intensity Interval Tr…Moderate-Intensity Aerobic…
Pain/sorenessMusculoskeletal and connective tissue disorders
LightheadednessGeneral disorders
FallGeneral disorders
FatigueGeneral disorders

Most-reported serious reactions: seizure, fall with fracture, delirium, stroke.

Data from ClinicalTrials.gov NCT03760016 adverse events section.

Sponsor's own description

The objective of this study is to determine the optimal training intensity and the minimum training duration needed to maximize immediate improvements in walking capacity in chronic stroke. A single-blind, phase II, 3-site randomized controlled trial has been planned. Fifty persons \>6 months post stroke will randomize to either moderate-intensity aerobic locomotor training or high-intensity interval locomotor training; each for 45 minutes, 3x/week for up to 36 total sessions over approximately 12 weeks. Clinical measures of walking function, aerobic fitness, daily walking activity and quality of life will be assessed at baseline (PRE) and after 4, 8 and 12 weeks of training (POST-4WK, POST-8WK, POST-12WK).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Optimal Intensity and Duration of Walking Rehabilitation in Patients With Chronic Stroke: A Randomized Clinical Trial.
    Boyne P, Billinger SA, Reisman DS, Awosika OO, et al · · 2023 · cited 103× · PMID 36822187 · DOI 10.1001/jamaneurol.2023.0033
  2. Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial.
    Miller A, Reisman DS, Billinger SA, Dunning K, et al · · 2021 · cited 18× · PMID 34271979 · DOI 10.1186/s13063-021-05419-x
  3. Training Parameters and Adaptations That Mediate Walking Capacity Gains from High-Intensity Gait Training Poststroke.
    Boyne P, Miller A, Schwab-Farrell SM, Sucharew H, et al · · 2025 · cited 7× · PMID 40025665 · DOI 10.1249/mss.0000000000003691
  4. Aerobic Exercise Improves Cortical Inhibitory Function After Stroke: A Preliminary Investigation.
    Palmer JA, Whitaker AA, Payne AM, Bartsch BL, et al · · 2024 · cited 5× · PMID 37436187 · DOI 10.1097/npt.0000000000000453
  5. Effects of maximal speed locomotor training on spatiotemporal gait changes in individuals with chronic stroke: A secondary analysis of a randomized controlled trial.
    Pressler D, Schwab-Farrell SM, Reisman DS, Billinger SA, et al · · 2025 · cited 2× · PMID 40712307 · DOI 10.1016/j.gaitpost.2025.07.325
  6. Effects of high-intensity exercise on rehabilitation of patients after stroke: a systematic review and meta-analysis of randomized controlled trials with high quality.
    Li S, Dou Y, Li H. · · 2025 · cited 1× · PMID 40843265 · DOI 10.3389/fneur.2025.1565118
  7. Higher Heart Rates During Locomotor High-Intensity Interval Training Are Associated With Gait Asymmetry and Fatigue After Stroke.
    Whitaker-Hilbig AA, Boyne P, Reisman DS, McCartney K, et al · · 2025 · PMID 42205471 · DOI 10.1097/cpt.0000000000000297
  8. Power and sample size for reversible linear mixed models with clustering and longitudinality: GLIMMPSE Version 3.
    Glueck DH, Li Q, Macleod AJ, Litkowski EM, et al · · 2025 · PMID 40901910 · DOI 10.1371/journal.pone.0329712

Verify or expand the search:

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other University of Cincinnati trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03760016.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing