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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270294
• Other study ID #: SPSC-3
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: April 1, 2018
• Start date: October 1, 2014
• Est. completion date: August 3, 2016

Study information

• Verified date: April 2018
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 3, 2016
• Est. primary completion date: October 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. A single ischemic stroke with Middle cerebral artery (MCA) stenosis

2. Men or women age 50-80 years

3. Physician's approvals to participate the study

4. Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment

5. The modified rankin scale level is 2 or 3

Exclusion Criteria:

1. 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

2. Temporal window were not found

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Thai traditional massage
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.
• No massage
The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.

Locations

Country	Name	City	State
Thailand	Faculty of Sports Science, Chulalongkorn University	Pathumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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.
Secondary	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.
Secondary	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)