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Completed

NCT Number: NCT02300207

Electroacupuncture is Effective in Cardiac Deconditioning Induced by Head-down Bed Rest

To investigate the changes of cardiovascular function during short-term simulated weightlessness after electroacupuncture (EA) treatment．

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Key information

Conditions

Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Weightlessness

Age range

20 year–28 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Aerospace Biodynamics, Faculty of Aerospace Medicine, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

electronic acupuncture treatment instrument

Device

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).

Primary outcomes

  1. Orthostatic tolerance test

    Time frame: 35 minutes

    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.

Secondary outcomes

  1. Measurements of cardiac systolic function and cerebral blood flow

    Time frame: 6 days

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Electracupuncture Could Ameliorate Orthostatic Intolerance After Weightlessness by Improving Cardiovascular Function

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
Nov 24, 2014

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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