Healthy SubjectsNCT01102634
Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Blood Lactate and Excessive Post-exercise Oxygen Consumption (EPOC)
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Healthy Subjects, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and EPOC Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Aug 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- with normal health (no known history of cardiovascular, pulmonary, metabolic or musculoskeletal diseases)
Who cannot join
- unable to communicate and follow the exercise procedures
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiopulmonary and Exercise Physiology Laboratory, The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Alice Jones, PhD, FACP, (852)27666749, alice.jones@polyu.edu.hk
Alice Jones, PhD, FACP
About this study
The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and EPOC
- Conditions
- Healthy Subjects
- Being tested
- Transcutaneous electrical nerve stimulation (TENS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
Application of TENS over acupuncture points
Transcutaneous electrical nerve stimulation (TENS)Device
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Acu-TENS | Experimental | Application of TENS over acupuncture points Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Placebo-TENS | Placebo comparator | Application of Acu-TENS but with no electricity Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lactate level
Finger pick method - measured by Lactate Plus (Nova Biomedical, USA)
Measured: Before exercise
Blood lactate level
Finger pick method - measured by Lactate Plus (Nova Biomedical, USA)
Measured: Immediately post exercise
Blood lactate level
Finger pick method - measured by Lactate Plus (Nova Biomedical, USA)
Measured: 15 minutes post exercise
Oxygen consumption
measured by K4b2 (Cosmed, Italy)
Measured: Measurements continued during exercise and until heart rate returned to baseline
Secondary outcomes (1)
Heart rate
measured by Polar heart rate monitor (RS800CX, Polar Electro, Finland)
Measured: Measurements continued during exercise and until heart rate returned to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Investigators
- Alice Jones, PhD, FACP, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102634
- Sponsor's protocol ID
- HSEARS20100407006
- Status last verified
- Apr 2010
- First submitted
- 8 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Blood Lactate and Excessive Post-exercise Oxygen Consumption (EPOC)
- ClinicalTrials.gov ID
- NCT01102634
- Acronym / sponsor ID
- HSEARS20100407006
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (estimated)
- First posted
- 13 Apr 2010 (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.
The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and EPOC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acu-TENS | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Application of TENS over acupuncture points |
| Placebo-TENS | Placebo comparator | Device: Transcutaneous electrical nerve stimulation (TENS)Application of Acu-TENS but with no electricity |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- with normal health (no known history of cardiovascular, pulmonary, metabolic or musculoskeletal diseases)
Key exclusion criteria (1 listed)
- unable to communicate and follow the exercise procedures
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)Application of TENS over acupuncture points | Device | Acu-TENS |
| Transcutaneous electrical nerve stimulation (TENS)Placebo | Device | Placebo-TENS |
Primary outcome
Blood lactate level
Time frame: Before exercise
Finger pick method - measured by Lactate Plus (Nova Biomedical, USA)
Blood lactate level
Time frame: Immediately post exercise
Finger pick method - measured by Lactate Plus (Nova Biomedical, USA)
Blood lactate level
Time frame: 15 minutes post exercise
Finger pick method - measured by Lactate Plus (Nova Biomedical, USA)
Oxygen consumption
Time frame: Measurements continued during exercise and until heart rate returned to baseline
measured by K4b2 (Cosmed, Italy)
1 secondary outcome
Heart rate
Time frame: Measurements continued during exercise and until heart rate returned to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
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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.
Alice Jones, PhD, FACP principal investigator
The Hong Kong Polytechnic 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 Transcutaneous electrical nerve stimulation (TENS) in people with Healthy Subjects, run by The Hong Kong Polytechnic University 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: status not confirmed, as of the sponsor's last update on 13 Apr 2010. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Jones, PhD, FACP ((852) 27666749, alice.jones@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lactate level (time frame: Before exercise). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2010.