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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Dr.Daroonwan Suksom, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT02270294
First received: October 14, 2014
Last updated: August 1, 2015
Last verified: August 2015
  Purpose
The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.

Condition Intervention
Ischemic Stroke
Other: Thai traditional massage
Other: No massage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Change from baseline in cerebrovascular reactivity [ Time Frame: baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs. ]
    - 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 [ Time Frame: Baseline, Post-test (immediately: 0 min after finish massage intervention) ]
    - Serum cortisol will be measured with cortisol EIA kit (Enzo Life Science, Switzerland).

  • Change from baseline in stress indicators [ Time Frame: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs. ]
    - Heart rate variability (HRV) will be measured using the Heart rate monitoring (RS800CX, Polar Electro, Oy, Finland)

  • Change from baseline in Peripheral arterial stiffness [ Time Frame: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs. ]
    - 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 [ Time Frame: baseline, Post-test (immediately: 0 min after finish massage intervention) ]
    • 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.


Estimated Enrollment: 18
Study Start Date: October 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02270294

Contacts
Contact: Daroonwan Suksom, Ph.D 6681-341-5736 daroonwanc@hotmail.com

Locations
Thailand
Faculty of Sports Science, Chulalongkorn University Recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Assoc.Prof.Dr.Daroonwan Suksom, Ph.D    6681-341-5736    daroonwanc@hotmail.com   
Principal Investigator: Assoc.Prof.Dr.Daroonwan Suksom, Ph.D.         
Sponsors and Collaborators
Chulalongkorn University
  More Information

Responsible Party: Assoc. Prof. Dr.Daroonwan Suksom, DSuksom, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02270294     History of Changes
Other Study ID Numbers: SPSC-3
Study First Received: October 14, 2014
Last Updated: August 1, 2015

Keywords provided by Chulalongkorn University:
Ischemic stroke
Thai traditional massage
Vascular function
Cerebral blood flow
Cerebrovascular reactivity

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 28, 2017