AsthmaNCT00824642
Effect of Acu-Transcutaneous Electrical Nerve Stimulation (TENS) on Post-Exercise Expiratory Flow Rate in Subjects With Asthma
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Asthma, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- 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
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2005to May 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis with asthma attending regular follow up at respiratory clinic
Who cannot join
- Allergic to gel
- Suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance
- Suffered from upper respiratory tract infection prior to the study
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Cardiopulmonary and exercise physiology laboratory, The Hong Kong Polytechnic University
Hong Kong
About this study
Official title: Effect of Acu-TENS on Post-Exercise Expiratory Flow Rate in Subjects With Asthma- A Randomized Controlled Trial
The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise.
- Conditions
- Asthma
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), placebo
- Keywords
- Asthma, Exercise training, TENS, Acupuncture, FEV1
- Medical subject headings
- Asthma
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
Applied 45 minutes prior to exercise
placeboDevice
placebo TENS applied prior to exercise
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Applied Acu-TENS prior to exercise Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Group 2 | Experimental | Applied Acu-TENS prior to and during exercise Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Group 3 | Placebo comparator | Applied placebo TENS prior to exercise Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC)
Measured: measured before exercise, immediately after exercise and at 20, 40 and 60 minutes post exercise
Secondary outcomes (1)
RPE, Exercise duration
Measured: immediately post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startMay 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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, Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824642
- Sponsor's protocol ID
- CRE-2004.362
- Status last verified
- Jan 2009
- First submitted
- 16 Jan 2009
- Last updated
- 19 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acu-TENS on Post-Exercise Expiratory Flow Rate in Subjects With Asthma- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00824642
- Acronym / sponsor ID
- CRE-2004.362
- Conditions
- Asthma
- Keywords
- Asthma, Exercise training, TENS, Acupuncture, FEV1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 19 Jan 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.
The objective of this study is to investigate the effectiveness of Acu-TENS (Transcutaneous electrical nerve stimulation applied on acupoints) on the post- exercise expiratory flow rate and exercise performance on the subjects with exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Applied Acu-TENS prior to exercise |
| Group 2 | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Applied Acu-TENS prior to and during exercise |
| Group 3 | Placebo comparator | Device: placeboApplied placebo TENS prior to exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis with asthma attending regular follow up at respiratory clinic
Key exclusion criteria (3 listed)
- Allergic to gel
- Suffered from other neurological or cardiovascular or musculoskeletal disorders that may affect their exercise performance
- Suffered from upper respiratory tract infection prior to the study
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)Applied 45 minutes prior to exercise | Device | Group 1, Group 2 |
| placeboplacebo TENS applied prior to exercise | Device | Group 3 |
Primary outcome
Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC)
Time frame: measured before exercise, immediately after exercise and at 20, 40 and 60 minutes post exercise
1 secondary outcome
RPE, Exercise duration
Time frame: immediately post exercise
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 19 Jan 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, 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 Asthma, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 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 19 Jan 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 Hong Kong. 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 volume in one second (FEV1) and Forced vital capacity (FVC) (time frame: measured before exercise, immediately after exercise and at 20, 40 and 60 minutes post exercise). 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 19 Jan 2009.