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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate-Intensity Aerobic Training
High-Intensity Interval Training
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Locomotion, Aerobic, Intensity, Dosing

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 40-80 years at time of consenting
  2. Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date
  3. Walking speed <1.0 m/s on the 10-meter walk test
  4. 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)
  5. Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
  6. Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 METs)
  7. Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

Exclusion Criteria:

  1. 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)
  2. 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
  3. Hospitalization for cardiac or pulmonary disease within past 3 months
  4. Implanted pacemaker or defibrillator
  5. Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
  6. Severe lower limb spasticity (Ashworth >2)
  7. Recent history (<3 months) of illicit drug or alcohol abuse or significant mental illness
  8. Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider
  9. Currently participating in physical therapy or another interventional study
  10. 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
  11. Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
  12. Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
  13. 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)
  14. Pregnancy
  15. Previous exposure to fast treadmill walking (>3 cumulative hours) during clinical or research therapy in the past year

Sites / Locations

  • University of Delaware
  • University of Kansas Medical Center
  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate-Intensity Aerobic Training

High-Intensity Interval Training

Arm Description

Outcomes

Primary Outcome Measures

Six-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Six-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Six-Minute Walk Test Distance
Total distance walked in 6 minutes in meters

Secondary Outcome Measures

Comfortable Gait Speed
From 10-meter walk test, in meters per second
Fast Gait Speed
From 10-meter walk test, in meters per second
Aerobic Fitness
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
PROMIS-Fatigue Scale
An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total score will be calculated by averaging the scores for each item.

Full Information

First Posted
November 26, 2018
Last Updated
July 18, 2023
Sponsor
University of Cincinnati
Collaborators
University of Delaware, University of Kansas Medical Center, Children's Hospital Medical Center, Cincinnati, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03760016
Brief Title
Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke
Official Title
Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
University of Delaware, University of Kansas Medical Center, Children's Hospital Medical Center, Cincinnati, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Locomotion, Aerobic, Intensity, Dosing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate-Intensity Aerobic Training
Arm Type
Active Comparator
Arm Title
High-Intensity Interval Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Moderate-Intensity Aerobic Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High-Intensity Interval Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six-Minute Walk Test Distance
Description
Total distance walked in 6 minutes in meters
Time Frame
Change Six-Minute Walk Test Distance from Baseline to 4 Weeks
Title
Six-Minute Walk Test Distance
Description
Total distance walked in 6 minutes in meters
Time Frame
Change Six-Minute Walk Test Distance from Baseline to 8 Weeks
Title
Six-Minute Walk Test Distance
Description
Total distance walked in 6 minutes in meters
Time Frame
Change Six-Minute Walk Test Distance from Baseline to 12 Weeks
Secondary Outcome Measure Information:
Title
Comfortable Gait Speed
Description
From 10-meter walk test, in meters per second
Time Frame
4 ,8, 12 weeks
Title
Fast Gait Speed
Description
From 10-meter walk test, in meters per second
Time Frame
4 ,8, 12 weeks
Title
Aerobic Fitness
Description
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Time Frame
4 ,8, 12 weeks
Title
PROMIS-Fatigue Scale
Description
An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total score will be calculated by averaging the scores for each item.
Time Frame
4 ,8, 12 weeks
Other Pre-specified Outcome Measures:
Title
Exercise Capacity
Description
Time to exhaustion during treadmill graded exercise test, recorded in minutes
Time Frame
4 ,8, 12 weeks
Title
Peak Oxygen Consumption Rate
Description
Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Time Frame
4 ,8, 12 weeks
Title
Metabolic Cost of Gait
Description
Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter
Time Frame
4 ,8, 12 weeks
Title
EuroQol 5D-5L (EQ-5D-5L)
Description
A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and overall health. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total score will be calculated by averaging the scores for each item.
Time Frame
4 ,8, 12 weeks
Title
Activities-specific Balance Confidence Scale
Description
A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score will be calculated by averaging the scores for each item.
Time Frame
4 ,8, 12 weeks
Title
Daily Walking Activity
Description
Mean daily step count recorded with activity monitor, recorded as steps per day
Time Frame
4 ,8, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierce Boyne, DPT, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We deposited the final, de-identified dataset and data documentation into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive (URL below)
IPD Sharing Time Frame
Data are available now and should remain available indefinitely.
IPD Sharing Access Criteria
Established by the repository
IPD Sharing URL
https://dash.nichd.nih.gov/study/424597
Citations:
PubMed Identifier
36822187
Citation
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.
Results Reference
result
PubMed Identifier
34271979
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://dash.nichd.nih.gov/study/424597
Available IPD/Information Identifier
424597

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

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