HealthyNCT02320747
Immediate Effect of Tai Chi Exercise in Healthy Volunteers
A study testing Tai Chi in people with Healthy, run by Adwin Life Care at 1 site in India.
Trial summary
Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential movements, providing a smooth, continuous and low intensity activity. It has been promoted to improve balance and strength and to reduce falls in the elderly, especially those 'at risk'. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- Sep 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 25 years old
- Have given written informed consent
- Have a high school level of education
- Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.
- Have an active interest in exploring and developing their spiritual lives
- Cigarette smokers must agree to abstain from smoking on session days
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours
- Agree that for one week before each session, refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators.
Who cannot join
- Women who are pregnant or nursing
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality
- Epilepsy with history of seizures
- Insulin-dependent diabetes
- Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Tai Chi Exercise in Healthy Volunteers:Randomized Controlled Study
Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential movements, providing a smooth, continuous and low intensity activity. It has been promoted to improve balance and strength and to reduce falls in the elderly, especially those 'at risk'. The potential benefits in healthy younger age cohorts and for wider aspects of health have received less attention.
The present study documented prospective changes in balance and vascular responses for a community sample of adults.
- Conditions
- Healthy
- Being tested
- Tai Chi
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiOther
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Group | Experimental | Experienced instructor at teaching tai chi delivered in a group setting in the community lasted approximately 40 minutes. Participants in the program served as an active control group that matched to the program and delivered.The class comprised mainly seated exercises including stretching, low-level strength, and low-level cardiovascular exercise. Participants walked (warm-up and cool-down) for 7 min in class, remaining seated or standing with arm support the rest of the time. Receives: Other: Tai Chi |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate (HR)
Heart rate was recorded before and after the session.
Measured: 40 Minutes
Systolic Pressure (SP)
Measured: 40 minutes
Diastolic Pressure (DP)
Measured: 40 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startSep 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.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adwin Life Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai University of Sport, Warwick Research Services
- Responsible party
- Sponsor
- Investigators
- Avinash Mishra, MSc, Principal investigator, Shanghai University of SportDinghai Yu, Study director, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320747
- Sponsor's protocol ID
- Adwin009
- Status last verified
- Apr 2015
- First submitted
- 10 Dec 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Tai Chi Exercise in Healthy Volunteers:Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02320747
- Acronym / sponsor ID
- Adwin009
- Conditions
- Healthy
- Keywords
- Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Adwin Life CareIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai University of Sport, Warwick Research Services
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Dec 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.
Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential movements, providing a smooth, continuous and low intensity activity. It has been promoted to improve balance and strength and to reduce falls in the elderly, especially those 'at risk'. The potential benefits in healthy younger age cohorts and for wider aspects of health have received less attention.
The present study documented prospective changes in balance and vascular responses for a community sample of adults.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Group | Experimental | Other: Tai ChiExperienced instructor at teaching tai chi delivered in a group setting in the community lasted approximately 40 minutes. Participants in the program served as an active control group that matched to the program and delivered.The class comprised mainly seated exercises including stretching, low-level strength, and low-level cardiovascular exercise. Participants walked (warm-up and cool-down) for 7 min in class, remaining seated or standing with arm support the rest of the time. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18 to 25 years old
- Have given written informed consent
- Have a high school level of education
- Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.
- Have an active interest in exploring and developing their spiritual lives
Key exclusion criteria (5 listed)
- Women who are pregnant or nursing
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality
- Epilepsy with history of seizures
- Insulin-dependent diabetes
- Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
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 |
|---|---|---|
| Tai Chi | Other | Tai Chi Group |
Primary outcome
Heart rate (HR)
Time frame: 40 Minutes
Heart rate was recorded before and after the session.
Systolic Pressure (SP)
Time frame: 40 minutes
Diastolic Pressure (DP)
Time frame: 40 Minutes
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 7 Apr 2015.
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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.
Avinash Mishra, MSc principal investigator
Shanghai University of Sport
Dinghai Yu study director
Shanghai University of Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Healthy, run by Adwin Life Care at 1 site in India.
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 8 inclusion and 5 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 7 Apr 2015. 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 India. 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?
Heart rate (HR) (time frame: 40 Minutes). The study lists 3 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 7 Apr 2015.