HealthyNCT00998179
Effect of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Expiratory Flow Volume in Healthy Subjects
A study testing Acu-TENS in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one second (FEV1), a test of pulmonary function used to assess airway resistance, during sub-maximal treadmill exercise in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acu-TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- With normal health
Who cannot join
- Suffered from respiratory, cardiovascular, musculoskeletal, neurological or endocrine disorders
- No allergic to gel
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
Hong Kong
About this study
This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one second (FEV1), a test of pulmonary function used to assess airway resistance, during sub-maximal treadmill exercise in healthy subjects.
- Conditions
- Healthy
- Being tested
- Acu-TENS, Placebo-TENS
- Keywords
- TENS, acupuncture, FEV1, Normal Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acu-TENSDevice
Application of Acu-TENS (with electrical output from the machine)
Placebo-TENSDevice
Application of Acu-TENS (without electrical output from the machine)
| Study group | Role | What they receive |
|---|---|---|
| Acu-TENS | Active comparator | Application of Acu-TENS prior to exercise Receives: Device: Acu-TENS |
| Placebo-TENS | Placebo comparator | Application of Acu-TENS (without electrical output from the machine) prior to exercise Receives: Device: Placebo-TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory flow volume in one second (FEV1)and forced vital capacity (FVC)
Measured: before and immediate after the exercise test
Forced expiratory flow volume in one second (FEV1) and forced vital capacity (FVC)
Measured: at 15min, 30 min and 45min after the exercise test
Secondary outcomes (1)
Exercise duration
Measured: Immediately after the exercise test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Investigators
- Alice Jones, PhD, FACP, Principal investigator, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998179
- Sponsor's protocol ID
- RS9/10
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Expiratory Flow Volume in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00998179
- Acronym / sponsor ID
- RS9/10
- Conditions
- Healthy
- Keywords
- TENS, acupuncture, FEV1, Normal Healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- First posted
- 20 Oct 2009 (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.
This study aims to investigate the effect of Acu-TENS on forced expiratory volume in one second (FEV1), a test of pulmonary function used to assess airway resistance, during sub-maximal treadmill exercise in healthy subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acu-TENS | Active comparator | Device: Acu-TENSApplication of Acu-TENS prior to exercise |
| Placebo-TENS | Placebo comparator | Device: Placebo-TENSApplication of Acu-TENS (without electrical output from the machine) prior to exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- With normal health
Key exclusion criteria (2 listed)
- Suffered from respiratory, cardiovascular, musculoskeletal, neurological or endocrine disorders
- No allergic to gel
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 |
|---|---|---|
| Acu-TENSApplication of Acu-TENS (with electrical output from the machine) | Device | Acu-TENS |
| Placebo-TENSApplication of Acu-TENS (without electrical output from the machine) | Device | Placebo-TENS |
Primary outcome
Forced expiratory flow volume in one second (FEV1)and forced vital capacity (FVC)
Time frame: before and immediate after the exercise test
Forced expiratory flow volume in one second (FEV1) and forced vital capacity (FVC)
Time frame: at 15min, 30 min and 45min after the exercise test
1 secondary outcome
Exercise duration
Time frame: Immediately after the exercise test
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 20 Oct 2009.
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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
Department of Rehabilitation Sciences, 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 Acu-TENS in people with Healthy, 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 2 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 20 Oct 2009. 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?
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?
Forced expiratory flow volume in one second (FEV1)and forced vital capacity (FVC) (time frame: before and immediate after the exercise test). The study lists 2 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 20 Oct 2009.