The Effect of Aerobic Exercise in Patients With Lacunar Stroke (HITPALS)

September 5, 2022 updated by: Christina Kruuse, Herlev Hospital

High-intensity Training in Patients With Lacunar Stroke (HITPALS)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Little is known about effect of exercise for patients with lacunar stroke, no studies have investigated the feasibility or effect of aerobic exercise in this subgroup of stroke. The patients have few and temporary symptoms and are therefore early discharged from the hospital. After an cerebral infarct the patients have increased risk of recurrent stroke and they are at risk of developing cognitive deficits or vascular dementia over time. Researchers want to investigate if high-intensity training at home in the acute phase has an effect on aerobic fitness, endothelial response and health profile in this potential fragile group of patients. We hope to increase the patients´ physical and mental function, and thereby prevent a recurrent stroke and slow the progression of vascular diseases.

Study Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital, Dept Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Amendment 1 (version 4.0, June 2016) has been modified to allow an extended inclusion period from 0-21 days (previously 0-7 days).

Also, to allow inclusion of patients with recurrent lacunar stroke, with clinical symptoms and a corresponding ischemic lesion on MRI.

Amendment 2 (version 5.0, June 2017) has allowed inclusion from two other stroke units in the Capital Region of Copenhagen due to low recruitment rate. The article describes protocol version 5.0 from June 6th. 2017

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Prophylactic stroke medication and recommendations for lifestyle changes
Drug: prophylactic stroke medication
Usual care medication for stroke prophylaxis
Behavioral: Recommendations for lifestyle changes
Advise on diet, alcohol, smoking and exercise
Active Comparator: Exercise
Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
Drug: prophylactic stroke medication
Usual care medication for stroke prophylaxis
Behavioral: Recommendations for lifestyle changes
Advise on diet, alcohol, smoking and exercise
Other: High-intensity training
high intensity training 5 days a week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the 'Graded Cycling Test with Talk Test'
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Sub-maximal exercise test on a stationary bicycle
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial response
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measurement of endothelial response by Endopat2000
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Physical Activity Scale (PAS)
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
A questionnaire that measures the level of self-reported physical activity
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Short time activity measurements
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Accelerometer (Axivity) to short time registration of physical activity (24 hours in an 8 day period (after inclusion, before 3 months visit, before 12 month visit)
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
The WHO-five Well-being Index (WHO-5)
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
A questionnaire that measures current mental well-being
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Montreal Cognitive Assessment (MOCA)
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
A cognitive screening test for detection of mild cognitive impairments
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Major Depression Inventory (MDI)
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
A self-report mood questionnaire
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Multidimensional Fatigue Inventory (MFI-20)
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
A 20-item self-report instrument designed to measure fatigue.
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Ull-Meter
Time Frame: At baseline, 3 (primary analysis), 6 and 12 months after baseline testing
An instrument which measures the individual stress reaction - it presents an objective number for the body and mind's state of stress.
At baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Blood samples
Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Blood samples to determine cardiovascular risk factors
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Magnetic resonance Imaging (MRI)
Time Frame: 12 months after baseline testing
Detection of new infarcts or white matter lesions
12 months after baseline testing

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardio-vascular event or death
Time Frame: 5 years
Follow-up 5 years from inclusion on cardiovascular events or death
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

University of Copenhagen
Association of Danish Physiotherapists

Investigators

  • Principal Investigator: Christina Kruuse, MD, DMSc, Herlev Hospital, Dept Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15012371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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