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

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

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: Thai traditional massage; Other: No massage

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathumwan, Bangkok, Thailand, 10330
      • Faculty of Sports Science, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thai traditional massage	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.; Other Names: Thai massage
Sham Comparator: No massage	Other: No massage; The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): October 31, 2015
• Study Completion (Actual): August 3, 2016

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: April 1, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Ischemic stroke; Vascular function; Cerebral blood flow; Cerebrovascular reactivity; Thai traditional massage
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: SPSC-3