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

NCT02300207 | Completed

• 1 other identifier: LL-2013163
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Abnormalities; Weightlessness

Keywords

Electroacupuncture; Cardiovascular function; Orthostatic tolerance; Head-down bed rest

Outcome Measures

Primary Outcomes (1)

• Orthostatic tolerance test

  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.

  35 minutes

Secondary Outcomes (1)

• Measurements of cardiac systolic function and cerebral blood flow

  6 days

Study Arms (2)

Control group

NO INTERVENTION

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.

Electroacupuncture group

EXPERIMENTAL

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).

Device: electronic acupuncture treatment instrument

Interventions

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).

Electroacupuncture group

Eligibility Criteria

• Age: 20 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• skeleton-muscle diseases, visual or acoustic dysfunction, organic and functional diseases of psychiatry and neurology as well as sleep disorders

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 26025383 DERIVED

MeSH Terms

Conditions

Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiqing Sun, Ph.D

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

CN (1)