NCT02550015

Brief Summary

The purpose of this study is to examine if high intensity interval training after stroke is more effective than standard care to increase maximal oxygen uptake, reduce known risk factors for recurrent stroke and improve function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2015

Typical duration 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

September 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2018

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

September 8, 2015

Last Update Submit

March 9, 2020

Conditions

Stroke

Keywords

Exercise trainingOxygen consumption

Outcome Measures

Primary Outcomes (1)

  • Maximal Oxygen Uptake

    A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer

    1 year after inclusion

Secondary Outcomes (9)

  • Change in blood pressure (systolic and diastolic)

    8 weeks and 12 months after inclusion

  • Walking speed

    8 weeks and 12 months after inclusion

  • Leisure time activity and inactive time

    8 weeks and 12 months after inclusion

  • Balance tested with the Bergs Balance Test

    8 weeks and 12 months after inclusion

  • Change in Blood tests

    8 weeks and 12 months after inclusion

  • +4 more secondary outcomes

Other Outcomes (6)

  • New cardiovascular or cerebrovascular incidents

    8 weeks and 12 months after inclusion

  • Severity of stroke

    8 weeks and 12 months after inclusion

  • Anxiety and depression after stroke

    8 weeks and 12 months after inclusion

  • +3 more other outcomes

Study Arms (2)

Training

EXPERIMENTAL

Supervised high intensity interval training (uphill treadmill walking 4 x 4 min at 90-95% of peak heart rate) 3 times weekly for 8 weeks

Behavioral: High intensity interval training

standard care

OTHER

Standard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle

Behavioral: General information

Interventions

High intensity interval trainingBEHAVIORAL

Uphill treadmill walking

Training
General informationBEHAVIORAL

Standard care

standard care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Approved informed consent
  • Independent walking \> 2 minutes
  • First episode of stroke (ischemic or hemorrhagic)
  • Minimum 3 months post-stroke
  • Living in the community and able to travel to assessment and training site
  • Approval to participate from the study's responsible medical doctor
  • Modified Rankin Scale 0-3

You may not qualify if:

  • Impaired cognitive function to give valid informed consent to participate
  • Instability of cardiac conditions (ie. serious rhythm disorder, valve malfunction)
  • Other conditions where test of maximal oxygen uptake is contraindicated
  • Poorly controlled hypertension (\>180/100), measured at rest
  • \> 5 years post stroke
  • Subarachnoid hemorrhage
  • Participating in other ongoing intervention study
  • Other serious illness influencing testing of cardiorespiratory fitness and function at 1 year follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience

Trondheim, Norway

Location

Related Publications (1)

  • Gjellesvik TI, Becker F, Tjonna AE, Indredavik B, Nilsen H, Brurok B, Torhaug T, Busuladzic M, Lydersen S, Askim T. Effects of High-Intensity Interval Training After Stroke (the HIIT-Stroke Study): A Multicenter Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):939-947. doi: 10.1016/j.apmr.2020.02.006. Epub 2020 Mar 4.

    PMID: 32145280RESULT

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

Study Officials

  • Torunn Askim, phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

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
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

December 2, 2018

Study Completion

December 2, 2018

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

NO(1)