NCT01958606

Brief Summary

The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable stroke

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

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 29, 2017

Completed
Last Updated

May 15, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

October 7, 2013

Results QC Date

February 12, 2017

Last Update Submit

April 8, 2017

Conditions

Stroke

Keywords

StrokeRehabilitationExerciseIntensityGait

Outcome Measures

Primary Outcomes (1)

  • Change in Peak Aerobic Capacity (VO2-peak)

    Baseline and 4 weeks

Secondary Outcomes (6)

  • Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)

    Baseline and 4 weeks

  • Change in Gait Velocity (10 Meter Walk Test)

    Baseline and 4 weeks

  • Change in 6-Minute Walk Test

    Baseline and 4 weeks

  • Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)

    Baseline and 4 weeks

  • Change in Fastest Treadmill Speed (Steep Ramp Test)

    Baseline and 4 weeks

  • +1 more secondary outcomes

Other Outcomes (10)

  • Change in Self-Efficacy and Outcome Expectations for Exercise Scale

    Baseline and 4 weeks

  • Change in Montreal Cognitive Assessment

    Baseline and 4 weeks

  • Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks

    Baseline and 4 weeks

  • +7 more other outcomes

Study Arms (2)

High-intensity interval training (HIT)

EXPERIMENTAL

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Other: High-intensity interval training (HIT)

Traditional aerobic training

ACTIVE COMPARATOR

Moderate intensity continuous aerobic exercise on a treadmill

Other: Traditional Aerobic Training

Interventions

High-intensity interval training (HIT)OTHER

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

High-intensity interval training (HIT)
Traditional Aerobic TrainingOTHER

Moderate intensity continuous aerobic exercise on a treadmill

Traditional aerobic training

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) age 35-90 years
  • \) unilateral stroke experienced \>6 months prior to enrollment
  • \) able to walk 10m overground with assistive devices as needed and no physical assistance
  • \) able to walk 3 minutes on the treadmill at \>.13m/s (0.3mph) with no aerobic exercise contraindications
  • \) stable cardiovascular condition (American Heart Association class B, allowing for aerobic capacity \<6 metabolic equivalents)
  • \) discharged from formal rehabilitation

You may not qualify if:

  • \) significant resting ECG abnormalities
  • \) evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test
  • \) hospitalization for cardiac or pulmonary disease within 3 months
  • \) pacemaker or implanted defibrillator
  • \) lower extremity claudication
  • \) unable to communicate with investigators or correctly answer consent comprehension questions
  • \) severe lower extremity spasticity (Ashworth \>2)
  • \) lower extremity weight bearing pain \>4/10 on visual analogue scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

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
513-558-7499

Study Officials

  • Brett Kissela, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

  • Kari Dunning, PhD, PT

    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
Principal Investigator

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 15, 2017

Results First Posted

March 29, 2017

Record last verified: 2017-04

Locations

US(1)