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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Other: Thai traditional massage; Other: No massage

• Registration Number: NCT02270294
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-01
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-21
• Primary Completion: 2015-10-31
• Study Completion: 2016-08-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-01
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Thai traditional massage	Thai traditional massage	-
No massage	No massage	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in cerebrovascular reactivity	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

Name	Time	Method
Change from baseline in stress indicators	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	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	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.

Trial Locations

Locations (1)

Faculty of Sports Science, Chulalongkorn University; 🇹🇭 Pathumwan, Bangkok, Thailand