Cardiovascular DiseasesNCT06303323
Comparative Effectiveness of Qigong Exercise Versus Wu Dang Tai Chi Chuan in CVD Risk Individuals
A study testing Qigong Exercise and Wu Dang Tai Chi in people with Cardiovascular Diseases and Risk Behavior, Health, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare whether the Qigong exercise or Wu Dang Tai Chi Chuan will be effective in improving exercise capacity and reducing stress in CVD-risk individuals. Based on preliminary data, Qigong and Tai-Chi may help treat anxiety and depression symptoms in patients with chronic illnesses as well as in healthy adults. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Cardiovascular Diseases, Risk Behavior, Health
- What is being tested?
- Qigong Exercise and Wu Dang Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2024to 15 Aug 2024
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- According to the Framingham risk calculator 10% to 20%+ for moderate to high-risk
- Patients at risk of CVD (last 6 months)
- Patients with either HTN, dyslipidemia, or diabetes
- Patients with less than 45 scores on the Berg Balance scale
- Stress from moderate to severe on PSS
- No regular physical exercise for at least 1 year
- Willing to take part
Who cannot join
- History of stroke
- CVD
- Acute Infection
- Acute injury
- Any diagnosed psychological issue
- MSK disorders
- Member of marital arts/dance
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 4600
About this study
Official title: Comparative Effectiveness of Qigong Exercise Versus Wu Dang Tai Chi Chuan on Exercise Capacity and Stress in CVD Risk Individuals
To compare whether the Qigong exercise or Wu Dang Tai Chi Chuan will be effective in improving exercise capacity and reducing stress in CVD-risk individuals. Based on preliminary data, Qigong and Tai-Chi may help treat anxiety and depression symptoms in patients with chronic illnesses as well as in healthy adults. Without the need for specialized equipment, Qigong and Tai-Chi are both readily adjustable mind-body exercises that may be done whenever and wherever. For this reason, Qigong and TaiChi should be extensively encouraged as ways to enhance emotional wellbeing
Read the detailed description
Since no comparison study has thus far been carried out in Pakistan which includes both interventions and very little literature is available. They belong to a group of Chinese exercises known for their efficacy in reducing blood pressure, stress, and quality of life and improving exercise capacity in patients with a high risk of CVD or CVD disease. These techniques are cost-effective treatment approaches and provide early outcomes. The positive results of this study would be helpful in the near future.
- Conditions
- Cardiovascular Diseases, Risk Behavior, Health
- Being tested
- Qigong Exercise, Wu Dang Tai Chi
- Keywords
- Qigong exercise, Wu Dang Tai Chi Chuan, Exercise capacity, CVD Risk individuals
- Medical subject headings
- Cardiovascular Diseases, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong ExerciseOther
Baduanjin Exercise will be performed which consists of 8 standing postures. At least 30 minutes per time. 10-13 min for a set of Badaunjin.
In the first 2 weeks, two sets of Baduanjin will be performed. Total Duration: 6 weeks Frequency: for 3 days/week. (alternative days) Intensity: low-intensity exercise Total Time: 50 Minutes Type: aerobic training
Wu Dang Tai ChiOther
Wu Dang 13 form postures will be performed. Initially, each posture will be performed 3 times then progressively increase to more according to the patient's discomfort.
Total Duration: 6 weeks Frequency: 3 times/ week (alternative day ) Intensity: Low to Moderate Intensity Time: 50 Minutes Type: aerobic training
| Study group | Role | What they receive |
|---|---|---|
| Qigong Exercise | Experimental | Baduanjin Exercise will be performed which consists of 8 standing postures. At least 30 minutes per time. 10-13 min for a set of Badaunjin Receives: Other: Qigong Exercise |
| Wu Dang Tai Chi | Experimental | Wu Dang 13 form postures will be performed. Initially, each posture will be performed 3 times then progressively increase to more according to the patient's discomfort. Receives: Other: Wu Dang Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Changes from baseline to 6 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional/exercise capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.
Measured: 6 weeks
Stress
Changes from baseline to 6 weeks after the intervention, measured through Perceived Stress Scale.
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303323
- Sponsor's protocol ID
- Rec/01816 Nawal Fatima
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Qigong Exercise Versus Wu Dang Tai Chi Chuan on Exercise Capacity and Stress in CVD Risk Individuals
- ClinicalTrials.gov ID
- NCT06303323
- Acronym / sponsor ID
- Rec/01816 Nawal Fatima
- Conditions
- Cardiovascular Diseases, Risk Behavior, Health
- Keywords
- Qigong exercise, Wu Dang Tai Chi Chuan, Exercise capacity, CVD Risk individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- 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.
To compare whether the Qigong exercise or Wu Dang Tai Chi Chuan will be effective in improving exercise capacity and reducing stress in CVD-risk individuals. Based on preliminary data, Qigong and Tai-Chi may help treat anxiety and depression symptoms in patients with chronic illnesses as well as in healthy adults. Without the need for specialized equipment, Qigong and Tai-Chi are both readily adjustable mind-body exercises that may be done whenever and wherever. For this reason, Qigong and TaiChi should be extensively encouraged as ways to enhance emotional wellbeing
Detailed description
Since no comparison study has thus far been carried out in Pakistan which includes both interventions and very little literature is available. They belong to a group of Chinese exercises known for their efficacy in reducing blood pressure, stress, and quality of life and improving exercise capacity in patients with a high risk of CVD or CVD disease. These techniques are cost-effective treatment approaches and provide early outcomes. The positive results of this study would be helpful in the near future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong Exercise | Experimental | Other: Qigong ExerciseBaduanjin Exercise will be performed which consists of 8 standing postures. At least 30 minutes per time. 10-13 min for a set of Badaunjin |
| Wu Dang Tai Chi | Experimental | Other: Wu Dang Tai ChiWu Dang 13 form postures will be performed. Initially, each posture will be performed 3 times then progressively increase to more according to the patient's discomfort. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- According to the Framingham risk calculator 10% to 20%+ for moderate to high-risk
- Patients at risk of CVD (last 6 months)
- Patients with either HTN, dyslipidemia, or diabetes
- Patients with less than 45 scores on the Berg Balance scale
- Stress from moderate to severe on PSS
Key exclusion criteria (7 listed)
- History of stroke
- CVD
- Acute Infection
- Acute injury
- Any diagnosed psychological issue
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 |
|---|---|---|
| Qigong ExerciseBaduanjin Exercise will be performed which consists of 8 standing postures. At least 30 minutes per time. 10-13 min for a set of Badaunjin. In the first 2 weeks, two sets of Baduanjin will be performed. Total Duration: 6 weeks Frequency: for 3 days/week. (alternative days) Intensity: low-intensity exercise Total Time: 50 Minutes Type: aerobic training | Other | Qigong Exercise |
| Wu Dang Tai ChiWu Dang 13 form postures will be performed. Initially, each posture will be performed 3 times then progressively increase to more according to the patient's discomfort. Total Duration: 6 weeks Frequency: 3 times/ week (alternative day ) Intensity: Low to Moderate Intensity Time: 50 Minutes Type: aerobic training | Other | Wu Dang Tai Chi |
Primary outcome
Exercise Capacity
Time frame: 6 weeks
Changes from baseline to 6 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional/exercise capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.
Stress
Time frame: 6 weeks
Changes from baseline to 6 weeks after the intervention, measured through Perceived Stress Scale. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress.
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 4 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Mehwish Waseem, MSPT-CPPT principal investigator
Riphah International 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 Qigong Exercise and Wu Dang Tai Chi in people with Cardiovascular Diseases and Risk Behavior, Health, run by Riphah International University at 1 site in Pakistan.
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 7 inclusion and 7 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 4 Sep 2024. 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 Pakistan. 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?
Exercise Capacity (time frame: 6 weeks). 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 4 Sep 2024.