Cardiovascular AbnormalitiesNCT02300207
Electroacupuncture is Effective in Cardiac Deconditioning Induced by Head-down Bed Rest
A study testing electronic acupuncture treatment instrument in people with Cardiovascular Abnormalities and Weightlessness, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
To investigate the changes of cardiovascular function during short-term simulated weightlessness after electroacupuncture (EA) treatment． Read more about this study
- Who is it for?
- Ages 20 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Abnormalities, Weightlessness
- What is being tested?
- electronic acupuncture treatment instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- skeleton-muscle diseases, visual or acoustic dysfunction, organic and functional diseases of psychiatry and neurology as well as sleep disorders
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Aerospace Biodynamics, Faculty of Aerospace Medicine, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: 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．
Read the 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
- Being tested
- electronic acupuncture treatment instrument
- Keywords
- Electroacupuncture, Cardiovascular function, Orthostatic tolerance, Head-down bed rest
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic acupuncture treatment instrumentDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: electronic acupuncture treatment instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 minutes
Secondary outcomes (1)
Measurements of cardiac systolic function and cerebral blood flow
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Sun, Air Force Military Medical University, China
- Investigators
- Xiqing Sun, Ph.D, Study director, Department of Aerospace Biodynamics, Faculty of Aerospace Medicine, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300207
- Sponsor's protocol ID
- LL-2013163
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26025383
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electracupuncture Could Ameliorate Orthostatic Intolerance After Weightlessness by Improving Cardiovascular Function
- ClinicalTrials.gov ID
- NCT02300207
- Acronym / sponsor ID
- LL-2013163
- Conditions
- Cardiovascular Abnormalities, Weightlessness
- Keywords
- Electroacupuncture, Cardiovascular function, Orthostatic tolerance, Head-down bed rest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: electronic acupuncture treatment instrumentDuring 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). |
Who may qualify
- Ages
- 20 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- skeleton-muscle diseases, visual or acoustic dysfunction, organic and functional diseases of psychiatry and neurology as well as sleep disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic acupuncture treatment instrumentElectroacupuncture 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). | Device | Electroacupuncture group |
Primary outcome
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.
1 secondary outcome
Measurements of cardiac systolic function and cerebral blood flow
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 26025383Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiqing Sun, Ph.D study director
Department of Aerospace Biodynamics, Faculty of Aerospace Medicine, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic acupuncture treatment instrument in people with Cardiovascular Abnormalities and Weightlessness, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic tolerance test (time frame: 35 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02300207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.