The Effect of Aerobic Exercise in Patients With Lacunar Stroke

Stroke, Lacunar Clinical Trial

— HITPALS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02731235
• Other study ID #: H-15012371
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2024

Study information

• Verified date: September 2022
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: March 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Lacunar

Intervention

Other:
• High-intensity training
high intensity training 5 days a week for 12 weeks

Drug:
• prophylactic stroke medication
Usual care medication for stroke prophylaxis

Behavioral:
• Recommendations for lifestyle changes
Advise on diet, alcohol, smoking and exercise

Locations

Country	Name	City	State
Denmark	Herlev Hospital, Dept Neurology	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Herlev Hospital	Association of Danish Physiotherapists, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardio-vascular event or death	Follow-up 5 years from inclusion on cardiovascular events or death	5 years
Primary	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	Endothelial response	measurement of endothelial response by Endopat2000	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	Physical Activity Scale (PAS)	A questionnaire that measures the level of self-reported physical activity	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	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)	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	The WHO-five Well-being Index (WHO-5)	A questionnaire that measures current mental well-being	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	Montreal Cognitive Assessment (MOCA)	A cognitive screening test for detection of mild cognitive impairments	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	Major Depression Inventory (MDI)	A self-report mood questionnaire	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	Multidimensional Fatigue Inventory (MFI-20)	A 20-item self-report instrument designed to measure fatigue.	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	Ull-Meter	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
Secondary	Blood samples	Blood samples to determine cardiovascular risk factors	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary	Magnetic resonance Imaging (MRI)	Detection of new infarcts or white matter lesions	12 months after baseline testing