Stroke, LacunarHITPALSNCT02731235
The Effect of Aerobic Exercise in Patients With Lacunar Stroke
A study testing High-intensity training, prophylactic stroke medication and Recommendations for lifestyle changes in people with Stroke, Lacunar, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Lacunar
- What is being tested?
- High-intensity training, prophylactic stroke medication and Recommendations for lifestyle changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lacunar stroke verified by clinical examination and CT- or MRI-scans
- able to speak and read Danish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Lacunar
- Being tested
- High-intensity training, prophylactic stroke medication, Recommendations for lifestyle changes
- Keywords
- Stroke, stroke, acute, Cerebral small vessel disease
- Medical subject headings
- Stroke, Lacunar, Stroke, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity trainingOther
high intensity training 5 days a week for 12 weeks
prophylactic stroke medicationDrug
Usual care medication for stroke prophylaxis
Recommendations for lifestyle changesBehavioural
Advise on diet, alcohol, smoking and exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Prophylactic stroke medication and recommendations for lifestyle changes Receives: Drug: prophylactic stroke medication; Behavioral: 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 Receives: Other: High-intensity training; Drug: prophylactic stroke medication; Behavioral: Recommendations for lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the 'Graded Cycling Test with Talk Test'
Sub-maximal exercise test on a stationary bicycle
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary outcomes (10)
Endothelial response
measurement of endothelial response by Endopat2000
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Physical Activity Scale (PAS)
A questionnaire that measures the level of self-reported physical activity
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
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)
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
The WHO-five Well-being Index (WHO-5)
A questionnaire that measures current mental well-being
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Montreal Cognitive Assessment (MOCA)
A cognitive screening test for detection of mild cognitive impairments
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Major Depression Inventory (MDI)
A self-report mood questionnaire
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Multidimensional Fatigue Inventory (MFI-20)
A 20-item self-report instrument designed to measure fatigue.
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Ull-Meter
An instrument which measures the individual stress reaction - it presents an objective number for the body and mind's state of stress.
Measured: At baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Blood samples
Blood samples to determine cardiovascular risk factors
Measured: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Magnetic resonance Imaging (MRI)
Detection of new infarcts or white matter lesions
Measured: 12 months after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, LacunarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Association of Danish Physiotherapists
- Responsible party
- Principal investigator, Christina Kruuse, Herlev Hospital
- Investigators
- Christina Kruuse, MD, DMSc, Principal investigator, Herlev Hospital, Dept Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731235
- Sponsor's protocol ID
- H-15012371
- Acronym
- HITPALS
- Status last verified
- Sep 2022
- First submitted
- 22 Jan 2016
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34184251Steen 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.
PubMed 31316451
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Training in Patients With Lacunar Stroke (HITPALS)
- ClinicalTrials.gov ID
- NCT02731235
- Acronym / sponsor ID
- HITPALS / H-15012371
- Conditions
- Stroke, Lacunar
- Keywords
- Stroke, stroke, acute, Cerebral small vessel disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Association of Danish Physiotherapists
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Drug: prophylactic stroke medication, Behavioral: Recommendations for lifestyle changesProphylactic stroke medication and recommendations for lifestyle changes |
| Exercise | Active comparator | Other: High-intensity training, Drug: prophylactic stroke medication, Behavioral: Recommendations for lifestyle changesProphylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- lacunar stroke verified by clinical examination and CT- or MRI-scans
- able to speak and read Danish
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity traininghigh intensity training 5 days a week for 12 weeks | Other | Exercise |
| prophylactic stroke medicationUsual care medication for stroke prophylaxis | Drug | Control, Exercise |
| Recommendations for lifestyle changesAdvise on diet, alcohol, smoking and exercise | Behavioural | Control, Exercise |
Primary outcome
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
10 secondary outcomes
Endothelial response
Time frame: 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
Short time activity measurements
Time frame: 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
Montreal Cognitive Assessment (MOCA)
Time frame: 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
Multidimensional Fatigue Inventory (MFI-20)
Time frame: 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
Blood samples
Time frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Magnetic resonance Imaging (MRI)
Time frame: 12 months after baseline testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 34184251Saunders 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.
- Derived from this study: PubMed 31316451Steen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Kruuse, MD, DMSc principal investigator
Herlev Hospital, Dept Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity training, prophylactic stroke medication and Recommendations for lifestyle changes in people with Stroke, Lacunar, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the 'Graded Cycling Test with Talk Test' (time frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02731235, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.