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

NCT03760016 | Completed Results DMC

• 2 other identifiers: 2017-5325R01HD093694
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Stroke

Keywords

Rehabilitation; Locomotion; Aerobic; Intensity; Dosing

Outcome Measures

Primary Outcomes (3)

• Six-Minute Walk Test Distance

  Total distance walked in 6 minutes in meters

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

• Six-Minute Walk Test Distance

  Total distance walked in 6 minutes in meters

  Change Six-Minute Walk Test Distance from Baseline to 8 Weeks

• Six-Minute Walk Test Distance

  Total distance walked in 6 minutes in meters

  Change Six-Minute Walk Test Distance from Baseline to 12 Weeks

Secondary Outcomes (12)

• Comfortable Gait Speed

  Change from Baseline to 4 Weeks

• Comfortable Gait Speed

  Change from Baseline to 8 Weeks

• Comfortable Gait Speed

  Change from Baseline to 12 Weeks

• Fast Gait Speed

  Change from Baseline to 4 Weeks

• Fast Gait Speed

  Change from Baseline to 8 Weeks

Other Outcomes (18)

• Exercise Capacity

  Change from Baseline to 4 Weeks

• Exercise Capacity

  Change from Baseline to 8 Weeks

• Exercise Capacity

  Change from Baseline to 12 Weeks

Study Arms (2)

Moderate-Intensity Aerobic Training

ACTIVE COMPARATOR

Behavioral: Moderate-Intensity Aerobic Training

High-Intensity Interval Training

EXPERIMENTAL

Behavioral: High-Intensity Interval Training

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.

Moderate-Intensity Aerobic Training

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.

High-Intensity Interval Training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80 years at time of consenting
• Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date
• Walking speed \<1.0 m/s on the 10-meter walk test
• Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
• Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
• Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \<6 metabolic equivalents)
• Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

You may not qualify if:

• Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out)
• Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
• Hospitalization for cardiac or pulmonary disease within past 3 months
• Implanted pacemaker or defibrillator
• Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
• Severe lower limb spasticity (Ashworth \>2)
• Recent history (\<3 months) of illicit drug or alcohol abuse or significant mental illness
• Major post-stroke depression (Patient Health Questionnaire \[PHQ-9\] ≥ 10) in the absence of depression management by a health care provider
• Currently participating in physical therapy or another interventional study
• Recent botulinum toxin injection to the paretic lower limb (\<3 months) or planning to have lower limb botulinum toxin injection in the next 4 months
• Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
• Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
• Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
• Pregnancy
• Previous exposure to fast treadmill walking (\>3 cumulative hours) during clinical or research therapy in the past year

Sponsors & Collaborators

• University of Cincinnati: lead
• University of Delaware: collaborator
• University of Kansas Medical Center: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

University of Delaware

Newark, Delaware, 19713, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (3)

• Boyne P, Billinger SA, Reisman DS, Awosika OO, Buckley S, Burson J, Carl D, DeLange M, Doren S, Earnest M, Gerson M, Henry M, Horning A, Khoury JC, Kissela BM, Laughlin A, McCartney K, McQuaid T, Miller A, Moores A, Palmer JA, Sucharew H, Thompson ED, Wagner E, Ward J, Wasik EP, Whitaker AA, Wright H, Dunning K. Optimal Intensity and Duration of Walking Rehabilitation in Patients With Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Apr 1;80(4):342-351. doi: 10.1001/jamaneurol.2023.0033.

  PMID: 36822187 RESULT

• Boyne P, Miller A, Schwab-Farrell SM, Sucharew H, Carl D, Billinger SA, Reisman DS. Training Parameters and Adaptations That Mediate Walking Capacity Gains from High-Intensity Gait Training Poststroke. Med Sci Sports Exerc. 2025 Jul 1;57(7):1285-1296. doi: 10.1249/MSS.0000000000003691. Epub 2025 Mar 3.

  PMID: 40025665 DERIVED

• Miller A, Reisman DS, Billinger SA, Dunning K, Doren S, Ward J, Wright H, Wagner E, Carl D, Gerson M, Awosika O, Khoury J, Kissela B, Boyne P. Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. Trials. 2021 Jul 16;22(1):457. doi: 10.1186/s13063-021-05419-x.

  PMID: 34271979 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Pierce Boyne
• Organization: University of Cincinnati

Pierce.Boyne@uc.edu

5135587499

Study Officials

• Pierce Boyne, DPT, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 30, 2018
• Study Start: January 4, 2019
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: March 26, 2025
• Results First Posted: July 20, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data are available now and should remain available indefinitely.
• Access Criteria: Established by the repository

Locations

US (3)