Back to resultsAcute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Thai traditional massage
No massage
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, Thai traditional massage, Vascular function, Cerebral blood flow, Cerebrovascular reactivity
Eligibility Criteria
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
Sites / Locations
- Faculty of Sports Science, Chulalongkorn University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Thai traditional massage
No massage
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline in stress indicators
- Serum cortisol will be measured with cortisol EIA kit (Enzo Life Science, Switzerland).
Change from baseline in stress indicators
- Heart rate variability (HRV) will be measured using the Heart rate monitoring (RS800CX, Polar Electro, Oy, Finland)
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.
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.
Full Information
NCT ID
NCT02270294
First Posted
October 14, 2014
Last Updated
April 1, 2018
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT02270294
Brief Title
Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
Official Title
Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
October 31, 2015 (Actual)
Study Completion Date
August 3, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
5. Study Description
Brief Summary
The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic stroke, Thai traditional massage, Vascular function, Cerebral blood flow, Cerebrovascular reactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thai traditional massage
Arm Type
Experimental
Arm Title
No massage
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Thai traditional massage
Other Intervention Name(s)
Thai massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No massage
Intervention Description
The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.
Primary Outcome Measure Information:
Title
Change from baseline in cerebrovascular reactivity
Description
- 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.
Time Frame
baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Secondary Outcome Measure Information:
Title
Change from baseline in stress indicators
Description
- Serum cortisol will be measured with cortisol EIA kit (Enzo Life Science, Switzerland).
Time Frame
Baseline, Post-test (immediately: 0 min after finish massage intervention)
Title
Change from baseline in stress indicators
Description
- Heart rate variability (HRV) will be measured using the Heart rate monitoring (RS800CX, Polar Electro, Oy, Finland)
Time Frame
Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Title
Change from baseline in Peripheral arterial stiffness
Description
- 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.
Time Frame
Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Title
Change from baseline in blood chemistry
Description
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.
Time Frame
baseline, Post-test (immediately: 0 min after finish massage intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Sports Science, Chulalongkorn University
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
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Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
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