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

Primary Purpose

Stroke, Lacunar

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High-intensity training
prophylactic stroke medication
Recommendations for lifestyle changes
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke, Lacunar focused on measuring Stroke, stroke, acute, Cerebral small vessel disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev Hospital, Dept Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control

Exercise

Arm Description

Prophylactic stroke medication and recommendations for lifestyle changes

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

Outcomes

Primary Outcome Measures

Difference in the 'Graded Cycling Test with Talk Test'
Sub-maximal exercise test on a stationary bicycle

Secondary Outcome Measures

Endothelial response
measurement of endothelial response by Endopat2000
Physical Activity Scale (PAS)
A questionnaire that measures the level of self-reported physical activity
Short time activity measurements
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)
The WHO-five Well-being Index (WHO-5)
A questionnaire that measures current mental well-being
Montreal Cognitive Assessment (MOCA)
A cognitive screening test for detection of mild cognitive impairments
Major Depression Inventory (MDI)
A self-report mood questionnaire
Multidimensional Fatigue Inventory (MFI-20)
A 20-item self-report instrument designed to measure fatigue.
Ull-Meter
An instrument which measures the individual stress reaction - it presents an objective number for the body and mind's state of stress.
Blood samples
Blood samples to determine cardiovascular risk factors
Magnetic resonance Imaging (MRI)
Detection of new infarcts or white matter lesions

Full Information

First Posted
January 22, 2016
Last Updated
September 5, 2022
Sponsor
Herlev Hospital
Collaborators
University of Copenhagen, Association of Danish Physiotherapists
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1. Study Identification

Unique Protocol Identification Number
NCT02731235
Brief Title
The Effect of Aerobic Exercise in Patients With Lacunar Stroke
Acronym
HITPALS
Official Title
High-intensity Training in Patients With Lacunar Stroke (HITPALS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
University of Copenhagen, Association of Danish Physiotherapists

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Lacunar
Keywords
Stroke, stroke, acute, Cerebral small vessel disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Prophylactic stroke medication and recommendations for lifestyle changes
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
Intervention Type
Other
Intervention Name(s)
High-intensity training
Intervention Description
high intensity training 5 days a week for 12 weeks
Intervention Type
Drug
Intervention Name(s)
prophylactic stroke medication
Intervention Description
Usual care medication for stroke prophylaxis
Intervention Type
Behavioral
Intervention Name(s)
Recommendations for lifestyle changes
Intervention Description
Advise on diet, alcohol, smoking and exercise
Primary Outcome Measure Information:
Title
Difference in the 'Graded Cycling Test with Talk Test'
Description
Sub-maximal exercise test on a stationary bicycle
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary Outcome Measure Information:
Title
Endothelial response
Description
measurement of endothelial response by Endopat2000
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Physical Activity Scale (PAS)
Description
A questionnaire that measures the level of self-reported physical activity
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Short time activity measurements
Description
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)
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
The WHO-five Well-being Index (WHO-5)
Description
A questionnaire that measures current mental well-being
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Montreal Cognitive Assessment (MOCA)
Description
A cognitive screening test for detection of mild cognitive impairments
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Major Depression Inventory (MDI)
Description
A self-report mood questionnaire
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Multidimensional Fatigue Inventory (MFI-20)
Description
A 20-item self-report instrument designed to measure fatigue.
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Ull-Meter
Description
An instrument which measures the individual stress reaction - it presents an objective number for the body and mind's state of stress.
Time Frame
At baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Blood samples
Description
Blood samples to determine cardiovascular risk factors
Time Frame
at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Title
Magnetic resonance Imaging (MRI)
Description
Detection of new infarcts or white matter lesions
Time Frame
12 months after baseline testing
Other Pre-specified Outcome Measures:
Title
Cardio-vascular event or death
Description
Follow-up 5 years from inclusion on cardiovascular events or death
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Kruuse, MD, DMSc
Organizational Affiliation
Herlev Hospital, Dept Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital, Dept Neurology
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34184251
Citation
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.
Results Reference
derived
PubMed Identifier
31316451
Citation
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.
Results Reference
derived

Learn more about this trial

The Effect of Aerobic Exercise in Patients With Lacunar Stroke

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