NCT02731235

Brief Summary

In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

7.3 years

First QC Date

January 22, 2016

Last Update Submit

September 5, 2022

Conditions

Stroke, Lacunar

Keywords

Strokestroke, acuteCerebral small vessel disease

Outcome Measures

Primary Outcomes (1)

  • Difference in the 'Graded Cycling Test with Talk Test'

    Sub-maximal exercise test on a stationary bicycle

    at baseline, 3 (primary analysis), 6 and 12 months after baseline testing

Secondary Outcomes (10)

  • Endothelial response

    at baseline, 3 (primary analysis), 6 and 12 months after baseline testing

  • Physical Activity Scale (PAS)

    at baseline, 3 (primary analysis), 6 and 12 months after baseline testing

  • Short time activity measurements

    at baseline, 3 (primary analysis), 6 and 12 months after baseline testing

  • The WHO-five Well-being Index (WHO-5)

    at baseline, 3 (primary analysis), 6 and 12 months after baseline testing

  • Montreal Cognitive Assessment (MOCA)

    at baseline, 3 (primary analysis), 6 and 12 months after baseline testing

  • +5 more secondary outcomes

Other Outcomes (1)

  • Cardio-vascular event or death

    5 years

Study Arms (2)

Control

OTHER

Prophylactic stroke medication and recommendations for lifestyle changes

Drug: prophylactic stroke medicationBehavioral: Recommendations for lifestyle changes

Exercise

ACTIVE COMPARATOR

Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks

Other: High-intensity trainingDrug: prophylactic stroke medicationBehavioral: Recommendations for lifestyle changes

Interventions

High-intensity trainingOTHER

high intensity training 5 days a week for 12 weeks

Exercise
prophylactic stroke medicationDRUG

Usual care medication for stroke prophylaxis

ControlExercise
Recommendations for lifestyle changesBEHAVIORAL

Advise on diet, alcohol, smoking and exercise

ControlExercise

Eligibility Criteria

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

You may qualify if:

  • lacunar stroke verified by clinical examination and CT- or MRI-scans
  • able to speak and read Danish

You may not qualify if:

  • previous large artery stroke,
  • symptoms or co-morbidities in the musculoskeletal system, which hinder bicycling,
  • dyspnoea caused by heart or pulmonary disease,
  • aphasia or dementia which hinder completion of the Talk Test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital, Dept Neurology

Herlev, 2730, Denmark

Location

Related Publications (2)

  • Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

    PMID: 34184251DERIVED

  • Steen Krawcyk R, Vinther A, Petersen NC, Faber J, Iversen HK, Christensen T, Lambertsen KL, Rehman S, Klausen TW, Rostrup E, Kruuse C. Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. Front Neurol. 2019 Jun 28;10:664. doi: 10.3389/fneur.2019.00664. eCollection 2019.

    PMID: 31316451DERIVED

MeSH Terms

Conditions

Stroke, LacunarStrokeCerebral Small Vessel Diseases

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesThrombotic StrokeIschemic StrokeVascular DiseasesCardiovascular DiseasesBrain InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Christina Kruuse, MD, DMSc

    Herlev Hospital, Dept Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, consultant neurologist

Study Record Dates

First Submitted

January 22, 2016

First Posted

April 7, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2023

Study Completion

March 1, 2024

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)