High Intensity Interval Training in Chronic Stroke

NCT ID: NCT01958606

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-08-31

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.

Detailed Description

Participants were randomized to either HIT or traditional aerobic training; each 25 minutes, 3 times per week for 4 weeks. Outcomes were measured before and after training by a blinded rater.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High-intensity interval training (HIT)

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Group Type: EXPERIMENTAL

High-intensity interval training (HIT)

Intervention Type: OTHER

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Traditional aerobic training

Moderate intensity continuous aerobic exercise on a treadmill

Group Type: ACTIVE_COMPARATOR

Traditional Aerobic Training

Intervention Type: OTHER

Moderate intensity continuous aerobic exercise on a treadmill

Interventions

High-intensity interval training (HIT)

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Intervention Type: OTHER

Traditional Aerobic Training

Moderate intensity continuous aerobic exercise on a treadmill

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

For the transcranial magnetic stimulation substudy, additional exclusions will also be applied. These include large cerebral infarcts or other structural defects with the potential to increase seizure risk, uncontrolled seizures, metal implants and previous craniotomy.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Physical Therapy Association

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Brett Kissela

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett Kissela, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Kari Dunning, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

HIT in chronic stroke

Identifier Type: -

Identifier Source: org_study_id