NCT02858349

Brief Summary

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

July 29, 2016

Results QC Date

November 26, 2018

Last Update Submit

November 26, 2018

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Walking Speed

    10-meter walk test

    Change from 4-weeks to 8-weeks

Secondary Outcomes (11)

  • Gait Symmetry

    baseline, 4 weeks, 8 weeks

  • Metabolic Cost of Gait

    baseline, 4 weeks, 8 weeks

  • Aerobic Capacity

    baseline, 4 weeks, 8 weeks

  • NIH Toolbox - Cognition Domain

    baseline, 4 weeks, 8 weeks

  • NIH Toolbox Standing Balance Test

    baseline, 4 weeks, 8 weeks

  • +6 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL

4-week control period with no intervention and 4-weeks of high-intensity interval training

Behavioral: No interventionBehavioral: High-intensity interval training

Interventions

No interventionBEHAVIORAL

No intervention

Arm 1
High-intensity interval trainingBEHAVIORAL

High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods

Arm 1

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 30-90 years
  • unilateral stroke experienced \>6 months prior to enrollment in middle cerebral artery (MCA) territory without complete disruption of the putamen on the lesion side
  • 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 physical assistance

You may not qualify if:

  • MRI incompatibility (e.g. metallic or electronic implants, severe claustrophobia)
  • inability to perform mental imagery (time dependent motor imagery screening test \[TDMI\])
  • evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test, or significant baseline ECG abnormalities that would make an exercise ECG uninterpretable
  • recent (\<3 months) cardiopulmonary hospitalization
  • unable to communicate with investigators or correctly answer consent comprehension questions
  • significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
  • severe lower extremity (LE) spasticity (Ashworth \>2)
  • recent (\<3 months) illicit drug or alcohol abuse or significant mental illness
  • major post-stroke depression (PHQ-9 ≥10) in the absence of medical management
  • participating in physical therapy or another interventional research study;
  • recent (\<3 months) paretic LE botulinum toxin injection
  • concurrent progressive neurologic disorder or other major medical, orthopedic or peripheral vascular conditions that would limit improvement
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Pierce Boyne
Organization
University of Cincinnati
Pierce.Boyne@uc.edu
5135587499

Study Officials

  • Pierce Boyne, PT, DPT, NCS

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor was blinded to study design, including when participant was in control phase versus intervention phase
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 8, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 15, 2019

Results First Posted

March 15, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)