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Completed

NCT Number: NCT02270294

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports Science, Chulalongkorn University

Pathumwan, Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thai traditional massage

Other

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

No massage

Other

The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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)

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 21, 2014
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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