Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients

Study Overview
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Brief Summary
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The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.

Official Title
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Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: Thai traditional massage
* Other: No massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A single ischemic stroke with Middle cerebral artery (MCA) stenosis Men or women age 50-80 years Physician's approvals to participate the study Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment The modified rankin scale level is 2 or 3 Exclusion Criteria: History of serious diseases Musculoskeletal diseases (Chronic arthritis, Lower spondylosis/spondylolisthesis with radiculopathy, Spinal deformity, Cervical spondylosis, Rheumatoid arthritis) Cardiovascular diseases (Poorly control hypertension, Heart disease class C and D) Neurological disorders (Peripheral neuropathy, Parkinson) Respiratory diseases (Chronic Obstructive Pulmonary Disease) Brain disorders (Cardioembolic, Severe dementia, Alzheimer's disease) Medical condition precluding taking Anticoagulant and Statin drug Temporal window were not found

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thai traditional massage<br> | Other: Thai traditional massage<br>* Thai traditional massage treatment based on original Thai traditional massage at Wat Po was use in this study. The participants will be assigned to receive one time of Thai traditional massage one time. Thai traditional massage techniques consists of petrissage, friction, and passive stretching on head, neck, shoulders, arms, back and legs for 60 minutes.<br>* Other names: Thai massage;|
| Sham Comparator: No massage<br> | Other: No massage<br>* The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in cerebrovascular reactivity | - Cerebrovascular reactivity or cerebral CO2 reactivity test will be assessed using the ultrasound equipment (CX50, Philips, USA). Blood flow velocity (BFV) of the middle cerebral artery (MCA) will be measured during normocapnic, hypocapnic, and hypercapnic states. Subjects will be asked to wear nose clips and breathe only through a mouthpiece. Baseline (3 minutes) recordings will be taken during spontaneous breathing of room air and then subjects underwent 1 minute of maximal voluntary hyperventilation with a duty cycle of 1 second. The MCA-BFV will be recorded during the last 20 seconds of hyperventilation. After that, subjects will be asked to breathe air containing a mixture of 5 % CO2 and 21 % O2 balanced with nitrogen spontaneously for 3 minutes and the MCA-BFV will be recorded during the last minute of hypercapnia. | baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in stress indicators | - Serum cortisol will be measured with cortisol EIA kit (Enzo Life Science, Switzerland). | Baseline, Post-test (immediately: 0 min after finish massage intervention) | 
| Change from baseline in stress indicators | - Heart rate variability (HRV) will be measured using the Heart rate monitoring (RS800CX, Polar Electro, Oy, Finland) | Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs. | 
| Change from baseline in Peripheral arterial stiffness | - Pulse wave velocity measurement will be assessed with MD6 bidirectional transcutaneous Doppler probe (Hokanson, Bellevue, WA, USA). All subjects will be monitored with an EKG and PWV measurements in the computer and used as timing markers for PWV identification. | Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs. | 
| Change from baseline in blood chemistry | Nitric oxide (NO) will be measured in plasma samples with Colorimetric nitric oxide assay kit (Biovision, USA). Beta-endorphin will be measured in serum samples with the commercial assay kit (Beta-endorphin [bEP] BioAssay ELISA kit [Human], US Biological Life Science). Malondialdehyde (MDA) will be determined using thiobarbituric acid reaction. | baseline, Post-test (immediately: 0 min after finish massage intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Thai traditional massage, Vascular function, Cerebral blood flow, Cerebrovascular reactivity