Pulmonary Arterial Hypertension PAHPAHNCT06454422
Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension
A study testing wu qinxi in people with Pulmonary Arterial Hypertension PAH, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
Aims and objective: The primary objective of this study was to assess the effects of a traditional Chinese Qigong practice known as Wuqinxi on activity tolerance，negative emotions and quality of life in pulmonary arterial hypertension patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension PAH
- What is being tested?
- wu qinxi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) patients with PAH related to IPAH(idiopathic pulmonary arterial), CTD(connective tissue disease), DPAH(drug-induced pulmonary hypertension), CHD(congenital heart disease) and associated with secondary disease, aged 18-75 years; (2)patients with PAH as defined by the American College of Cardiology Foundation/American Heart Association (right heart catheterization: mPAP≥20mmHg and PAWP≤15mmHg); (3) patients with WHO pulmonary arterial hypertension functional class II-III; (4) patients on drug-based treatment for ≥1 month and in the recovery period; (5) could read, write, and comprehend Chinese; (6) volunteered for this trial and provided written informed consent.
Who cannot join
- (1) patients unable or unwilling to complete the 6MWD; (2) The physician confirms that the disease requires bed rest or with severely impaired cardiopulmonary function, tumors, and limb dysfunction; (3) patients who were unable to complete the questionnaire independently; (4) a history of mental problems and cognitive impairment; or have had psychotherapy or taken any psychiatric medication in the past or present.(5) patients who were hospitalized with severe disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension to Enhance Exercise Tolerance ，Reduce Negative Emotions and Quality of Life: A Randomized Clinical Trial
Aims and objective: The primary objective of this study was to assess the effects of a traditional Chinese Qigong practice known as Wuqinxi on activity tolerance，negative emotions and quality of life in pulmonary arterial hypertension patients.
Methods: In the current prospective, randomized-controlled clinical trial, 60 patients with pulmonary arterial hypertension were randomly assigned to one of two groups: intervention or control. Participants in the intervention group received targeted pharmacological therapy and five sessions of qigong exercise per week. In contrast, individuals in the control group underwent targeted drug therapy and routine care. Observe the change in exercise tolerance as measured by the 6-minute walking distance (6MWD). Serological indicators (n-terminal brain natriuretic peptide precursor, NT-pro BNP) ,negative emotions(PHQ-9/GAD-7)and the MOS Item Short Form Health Survey (SF-36) or emPHasis-10 were used to assess patients condition and quality of life.
Read the detailed description
In the previous study, we examined the effects of comprehensive respiratory function exercise on exercise tolerance in patients with PAH. The results indicated that limb exercise combined with breath regulating guidance affects patients' physical health.Given these TCM principles, the current study investigated the clinical utility of Wuqinxi for improving patients' exercise tolerance and quality of life by comparing the intervention and control groups' NT-pro BNP scores, 6MWD data, negative emotionsand quality of life indices.
- Conditions
- Pulmonary Arterial Hypertension PAH
- Being tested
- wu qinxi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wu qinxiOther
Wuqinxi, also known as the Hundred-step Sweating Exercise, is one of the most emblematic Health qigong exercises. Huatuo, guided by the principle, formulated the 'Wuqinxi': " Running water is never stale and a door-hinge is never gets worm-eaten," and sums up the experiences of the fitness activities of Huatuo's predecessors that imitate the movements of tigers, deer, bears, apes, birds, and other animals, and are associated with human organs, meridians, and 'qi'
| Study group | Role | What they receive |
|---|---|---|
| Wuqinxi | Experimental | including observation of disease progression and complications, oxygen inhalation, medication guidance, rest and diet nursing, daily activity guidance, psychological guidance, and follow-up after discharge.
Patients mimicked precise Wuqinxi movements and breathing patterns while exercising. Receives: Other: wu qinxi |
| general nursing routines | No intervention | including observation of disease progression and complications, oxygen inhalation, medication guidance, rest and diet nursing, daily activity guidance, psychological guidance, and follow-up after discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker
NT-pro BNP was detected using a colloidal gold immunochromatography analyzer, model LEPU Quant 800, made in Beijing, China.
Measured: admission and discharge at the end of 3 months
6-minute walking distance
The 6MWD test for selected patients with stable illness was conducted in the corridor of the cardiology ward
Measured: admission and discharge at the end of 3 months
Quality of Life Assessment
emPHasis-10 or pulmonary hypertension health quality of life score, SF-36
Measured: admission and discharge at the end of 3 months
Secondary outcomes (1)
Negative emotions
PHQ-9/GAD-7
Measured: admission and discharge at the end of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension PAHStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang yun, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454422
- Sponsor's protocol ID
- KY20240422-KS-01
- Acronym
- PAH
- Status last verified
- Apr 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension to Enhance Exercise Tolerance ，Reduce Negative Emotions and Quality of Life: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06454422
- Acronym / sponsor ID
- PAH / KY20240422-KS-01
- Conditions
- Pulmonary Arterial Hypertension PAH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jun 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.
Aims and objective: The primary objective of this study was to assess the effects of a traditional Chinese Qigong practice known as Wuqinxi on activity tolerance，negative emotions and quality of life in pulmonary arterial hypertension patients.
Methods: In the current prospective, randomized-controlled clinical trial, 60 patients with pulmonary arterial hypertension were randomly assigned to one of two groups: intervention or control. Participants in the intervention group received targeted pharmacological therapy and five sessions of qigong exercise per week. In contrast, individuals in the control group underwent targeted drug therapy and routine care. Observe the change in exercise tolerance as measured by the 6-minute walking distance (6MWD). Serological indicators (n-terminal brain natriuretic peptide precursor, NT-pro BNP) ,negative emotions(PHQ-9/GAD-7)and the MOS Item Short Form Health Survey (SF-36) or emPHasis-10 were used to assess patients condition and quality of life.
Detailed description
In the previous study, we examined the effects of comprehensive respiratory function exercise on exercise tolerance in patients with PAH. The results indicated that limb exercise combined with breath regulating guidance affects patients' physical health.Given these TCM principles, the current study investigated the clinical utility of Wuqinxi for improving patients' exercise tolerance and quality of life by comparing the intervention and control groups' NT-pro BNP scores, 6MWD data, negative emotionsand quality of life indices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wuqinxi | Experimental | Other: wu qinxiincluding observation of disease progression and complications, oxygen inhalation, medication guidance, rest and diet nursing, daily activity guidance, psychological guidance, and follow-up after discharge. Patients mimicked precise Wuqinxi movements and breathing patterns while exercising. |
| general nursing routines | No intervention | –including observation of disease progression and complications, oxygen inhalation, medication guidance, rest and diet nursing, daily activity guidance, psychological guidance, and follow-up after discharge. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) patients with PAH related to IPAH(idiopathic pulmonary arterial), CTD(connective tissue disease), DPAH(drug-induced pulmonary hypertension), CHD(congenital heart disease) and associated with secondary disease, aged 18-75 years; (2)patients with PAH as defined by the American College of Cardiology Foundation/American Heart Association (right heart catheterization: mPAP≥20mmHg and PAWP≤15mmHg); (3) patients with WHO pulmonary arterial hypertension functional class II-III; (4) patients on drug-based treatment for ≥1 month and in the recovery period; (5) could read, write, and comprehend Chinese; (6) volunteered for this trial and provided written informed consent.
Key exclusion criteria (1 listed)
- (1) patients unable or unwilling to complete the 6MWD; (2) The physician confirms that the disease requires bed rest or with severely impaired cardiopulmonary function, tumors, and limb dysfunction; (3) patients who were unable to complete the questionnaire independently; (4) a history of mental problems and cognitive impairment; or have had psychotherapy or taken any psychiatric medication in the past or present.(5) patients who were hospitalized with severe disease.
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 |
|---|---|---|
| wu qinxiWuqinxi, also known as the Hundred-step Sweating Exercise, is one of the most emblematic Health qigong exercises. Huatuo, guided by the principle, formulated the 'Wuqinxi': " Running water is never stale and a door-hinge is never gets worm-eaten," and sums up the experiences of the fitness activities of Huatuo's predecessors that imitate the movements of tigers, deer, bears, apes, birds, and other animals, and are associated with human organs, meridians, and 'qi' | Other | Wuqinxi |
Primary outcome
Biomarker
Time frame: admission and discharge at the end of 3 months
NT-pro BNP was detected using a colloidal gold immunochromatography analyzer, model LEPU Quant 800, made in Beijing, China.
6-minute walking distance
Time frame: admission and discharge at the end of 3 months
The 6MWD test for selected patients with stable illness was conducted in the corridor of the cardiology ward
Quality of Life Assessment
Time frame: admission and discharge at the end of 3 months
emPHasis-10 or pulmonary hypertension health quality of life score, SF-36
1 secondary outcome
Negative emotions
Time frame: admission and discharge at the end of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Chang yun study chair
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing wu qinxi in people with Pulmonary Arterial Hypertension PAH, run by Nanjing First Hospital, Nanjing Medical 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 1 inclusion and 1 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 12 Jun 2024. 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.
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?
Contact Jia ruoya (15850516619, 274991496@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker (time frame: admission and discharge at the end of 3 months). 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 12 Jun 2024.