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

NCT ID: NCT02300207

Last Updated: 2014-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-10-31

Brief Summary

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

Conditions

Cardiovascular Abnormalities; Weightlessness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

electronic acupuncture treatment instrument

Intervention Type: 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).

Interventions

electronic acupuncture treatment instrument

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Jing Sun

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiqing Sun, Ph.D

Role: STUDY_DIRECTOR

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

Locations

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

Xi'an, Shaanxi, China

Countries

China

References

Sun J, Li X, Yang C, Wang Y, Shi F, Gao Y, Luan Q, Zhu Y, Sun X. Transcutaneous electrical acupuncture stimulation as a countermeasure against cardiovascular deconditioning during 4 days of head-down bed rest in humans. Acupunct Med. 2015 Oct;33(5):381-7. doi: 10.1136/acupmed-2014-010730. Epub 2015 May 29.

Reference Type: DERIVED

PMID: 26025383 (View on PubMed)

Other Identifiers

LL-2013163

Identifier Type: -

Identifier Source: org_study_id