- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02300207
Electroacupuncture is Effective in Cardiac Deconditioning Induced by Head-down Bed Rest
November 20, 2014 updated by: Jing Sun, Air Force Military Medical University, China
Electracupuncture Could Ameliorate Orthostatic Intolerance After Weightlessness by Improving Cardiovascular Function
To investigate the changes of cardiovascular function during short-term simulated weightlessness after electroacupuncture (EA) treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Spaceflight is associated with cardiovascular deregulation.
However, the influence of microgravity on the cardiovascular system and the underlying mechanisms and countermeasures remain largely unknown.
Our previous studies have demonstrated that electroacupuncture (EA) is effective at improving orthostatic tolerance (OT).
The purpose of this study was to determine if EA treatment can attenuate cardiovascular deconditioning induced by a 4-day -6° head-down bed rest (HDBR).
Fourteen healthy male subjects were randomly allocated into a control group (Con, n=6, 4 days HDBR without countermeasure) and an EA treatment group (EA, n=8, 4 days HDBR with EA at Neiguan [PC-6] for 30 min daily for 4 consecutive days during HDBR).
OT was estimated with a combination of +75°/20 min head-up tilt and lower body negative pressure test before and after HDBR.
Plasma hormones and heart rate variability were assessed before and after HDBR.
Cardiac systolic functions and cerebral blood flow were measured before, during, and after HDBR.
The data showed that EA treatment applied daily for 30 min during a 4-day HDBR prevented OT and cardiac systolic function from decrease, prevented autonomic dysfunction (a decrease in the activity of the parasympathetic nervous system), and increased the concentrations of plasma angiotensin II (Ang II) and aldosterone (Ald).
These results indicate that 30 min of daily EA treatment at PC-6 is highly effective in partially maintaining OT and cardiac systolic function.
Activation of the peripheral sympathetic nervous system and increased plasma hormones is largely responsible for maintaining OT after a 4-day HDBR.
Therefore, EA treatment appears to be an effective countermeasure against cardiovascular deconditioning induced by HDBR.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Department of Aerospace Biodynamics, Faculty of Aerospace Medicine, Fourth Military Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- The subjects were healthy and physically fit but were not athletes.Comprehensive physical, psychological and routine blood chemistry examinations were performed to select qualified subjects for this research.No medication, smoking, alcohol, or caffeinated drinks were allowed during the study.
Exclusion Criteria:
- skeleton-muscle diseases, visual or acoustic dysfunction, organic and functional diseases of psychiatry and neurology as well as sleep disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Subjects were in a resting, flat, head-down position -6° from the horizontal.
The entire bed rest period was composed of the 4-day head-down bed rest and 2-day period of data collection (before and after the bed rest period).
During all of these periods, there was intensive care monitoring.
All dining, washing, urination, and defecation were carried out in the bedridden state.
Changing position around the body axis was permitted.
Dietary intake was 2300-2500 kcal/day, and water intake was 1.0-1.5 L/day.
Urine samples (24 h) were collected every day throughout the study.
Body weight, heart rate (HR), and blood pressure (BP) were measured in the morning before breakfast.
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Experimental: Electroacupuncture group
During the bed rest phase, subjects in the Electroacupuncture(EA) groups received 30 min of EA treatment, while subjects in the Con group did not receive any treatment.EA was performed using small-sized (1.5 cm) cutaneous electrode pads placed bilaterally at the PC-6 points of the forearms.
The intensity of the electrical stimulation was adjusted to produce the most intense tolerable electrical sensation without muscle contractions or uncomfortable feelings at a frequency of 50 Hz using the Hwato electronic acupuncture treatment instrument (Model No. SDZ-II; Suzhou Medical Appliances Co, Ltd, Suzhou, China).
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Electroacupuncture was performed using small-sized (1.5 cm) cutaneous electrode pads placed bilaterally at the PC-6 points of the forearms (Supplementary Figure 1).
The intensity of the electrical stimulation was adjusted to produce the most intense tolerable electrical sensation without muscle contractions or uncomfortable feelings at a frequency of 50 Hz using the Hwato electronic acupuncture treatment instrument (Model No. SDZ-II; Suzhou Medical Appliances Co, Ltd, Suzhou, China).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Orthostatic tolerance test
Time Frame: 35 minutes
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The subjects remained at rest in a supine position for 15 min to collect control data, and then tilted to 75° head-up tilt testing (HUT) for 5 second followed by increasing steps of lower body negative pressure (LBNP).
LBNP began at -20mm Hg for 5 minutes followed by an increase of -20 mm Hg every 5 minutes until -60 mm Hg (total duration = 20 minutes) or presyncope.
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35 minutes
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurements of cardiac systolic function and cerebral blood flow
Time Frame: 6 days
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6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Xiqing Sun, Ph.D, Department of Aerospace Biodynamics, Faculty of Aerospace Medicine, Fourth Military Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 20, 2014
First Submitted That Met QC Criteria
November 20, 2014
First Posted (Estimate)
November 24, 2014
Study Record Updates
Last Update Posted (Estimate)
November 24, 2014
Last Update Submitted That Met QC Criteria
November 20, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LL-2013163
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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