AttentionPhase 1/2NCT00988702
Shaolin Dan Tian Breathing Fosters Relaxed and Attentive Mind
A Phase 1/2 study testing Dan Tian Breathing and Progressive muscle training in people with Attention and Electroencephalography, run by The Hong Kong Polytechnic University.
Trial summary
The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention, Electroencephalography
- What is being tested?
- Dan Tian Breathing and Progressive muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy controls
- age 20 to 60 years
Who cannot join
- history of head injury,
- seizure,
- stroke,
- other CNS diseases or psychiatric illnesses of psychosis or mania.
About this study
Official title: Shaolin Dan Tian Breathing Fosters Relaxed and Attentive Mind: A Randomized Controlled Neuroelectrophysiological Study
The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique.
Read the detailed description
Neuroelectrophysiological studies on various types of meditative breathing revealed its association with either a relaxing (i.e., enhanced alpha asymmetry) or an attentive state (i.e., enhanced intra- and inter-hemispheric theta coherence). The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique. This technique consists of two components -- Passive DTB and Active DTB, and is considered not only as a relaxation exercise but also a form of Qigong. Based upon some pilot neuroimaging data and clinical observation, it was hypothesized that after familiarizing with the method, practicing DTB can induce both relaxing and attentive states. Twenty-two adults received training on the DTB (experimental group) for one month. They were instructed to practice the technique daily, and at each practice, until they felt warm and/or relaxed. Twenty age-, gender- and education-matched adults receiving conventional progressive muscle relaxation training were recruited as control. All participation was voluntary. Quantitative EEG and bio-physiological data were collected at baseline and post training. Eyes-closed resting EEG data before and immediately after each type of breathing were obtained individually at two time points.
- Conditions
- Attention, Electroencephalography
- Being tested
- Dan Tian Breathing, Progressive muscle training
- Keywords
- Dan Tian Breathing, Physiological measurement, progressive muscle relaxation, Monitoring, Physiologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dan Tian BreathingBehavioural
Also called Dan Tian, Shaolin
Dan Tian Breathing for one month
Progressive muscle trainingBehavioural
Also called muscle training, relaxation
Progressive muscle training for one month
| Study group | Role | What they receive |
|---|---|---|
| Dan Tian Breathing | Experimental | subjects received one-month's training on the Dan Tian Breathing Receives: Behavioral: Dan Tian Breathing |
| Progressive muscle relaxation training | Active comparator | Subjects received one-month's conventional progressive muscle relaxation training Receives: Behavioral: Progressive muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative electroencephalography
Measured: Before and after one month's training
Secondary outcomes (1)
Bio-physiological measures
Measured: Before and after one month's training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Investigators
- Agnes S Chan, PhD, Principal investigator, The ChineseUniversity of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988702
- Sponsor's protocol ID
- Chanwuyi-0006
- Status last verified
- Oct 2009
- First submitted
- 30 Sep 2009
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shaolin Dan Tian Breathing Fosters Relaxed and Attentive Mind: A Randomized Controlled Neuroelectrophysiological Study
- ClinicalTrials.gov ID
- NCT00988702
- Acronym / sponsor ID
- Chanwuyi-0006
- Conditions
- Attention, Electroencephalography
- Keywords
- Dan Tian Breathing, Physiological measurement, progressive muscle relaxation, Monitoring, Physiologic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 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.
The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique.
Detailed description
Neuroelectrophysiological studies on various types of meditative breathing revealed its association with either a relaxing (i.e., enhanced alpha asymmetry) or an attentive state (i.e., enhanced intra- and inter-hemispheric theta coherence). The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique. This technique consists of two components -- Passive DTB and Active DTB, and is considered not only as a relaxation exercise but also a form of Qigong. Based upon some pilot neuroimaging data and clinical observation, it was hypothesized that after familiarizing with the method, practicing DTB can induce both relaxing and attentive states. Twenty-two adults received training on the DTB (experimental group) for one month. They were instructed to practice the technique daily, and at each practice, until they felt warm and/or relaxed. Twenty age-, gender- and education-matched adults receiving conventional progressive muscle relaxation training were recruited as control. All participation was voluntary. Quantitative EEG and bio-physiological data were collected at baseline and post training. Eyes-closed resting EEG data before and immediately after each type of breathing were obtained individually at two time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dan Tian Breathing | Experimental | Behavioral: Dan Tian Breathingsubjects received one-month's training on the Dan Tian Breathing |
| Progressive muscle relaxation training | Active comparator | Behavioral: Progressive muscle trainingSubjects received one-month's conventional progressive muscle relaxation training |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy controls
- age 20 to 60 years
Key exclusion criteria (4 listed)
- history of head injury,
- seizure,
- stroke,
- other CNS diseases or psychiatric illnesses of psychosis or mania.
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 |
|---|---|---|
| Dan Tian BreathingAlso: Dan Tian, ShaolinDan Tian Breathing for one month | Behavioural | Dan Tian Breathing |
| Progressive muscle trainingAlso: muscle training, relaxationProgressive muscle training for one month | Behavioural | Progressive muscle relaxation training |
Primary outcome
Quantitative electroencephalography
Time frame: Before and after one month's training
1 secondary outcome
Bio-physiological measures
Time frame: Before and after one month's training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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.
Agnes S Chan, PhD principal investigator
The ChineseUniversity of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dan Tian Breathing and Progressive muscle training in people with Attention and Electroencephalography, run by The Hong Kong Polytechnic University.
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 2 inclusion and 4 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 2 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Quantitative electroencephalography (time frame: Before and after one month's training). 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 2 Oct 2009.