StrokeNCT05930262
Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated
A study testing TCM acupuncture therapy, Conventional drug therapy and Rehabilitation therapy in people with Stroke and Lung Diseases, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial summary
The goal of this prospective randomized controlled study is to explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. Read more about this study
- Who is it for?
- Ages 28 to 80 years
- Conditions the study is for
- Stroke, Lung Diseases
- What is being tested?
- TCM acupuncture therapy, Conventional drug therapy and Rehabilitation therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 1 Jun 2023
- 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 28 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the diagnostic criteria of Western medicine for stroke complicated with pneumonia
- conforming to the TCM syndrome of vital qi deficiency and phlegm-heat obstructing the lung
- confirmed as the initial onset of stroke through CT or magnetic resonance imaging (MRI)
- clear consciousness, no cognitive impairment, and ability to cooperate with pulmonary function assessment and rehabilitation training
- willingness to participate in this study and sign the informed consent
Who cannot join
- Patients with systemic multi-organ failure such as the heart, brain, kidney, etc
- patients with a coronary metal stent or pacemaker implantation
- patients with malignant tumors
- patients with severe cognitive impairment, depression or mental disorders
- patients with pulmonary infections before stroke or caused by other causes
- patients in the acute phase of infection
Trial locations and contacts
1 site in 1 country.
China1 site
Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study
Shijiazhuang, Hebei, 050000
About this study
Official title: Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated With Pulmonary Infection: A Clinical Study
The goal of this prospective randomized controlled study is to explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. The intervention group and control group were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. To evaluate the clinical efficacy of both groups.
Read the detailed description
To explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. Using a prospective randomized controlled study, 72 patients with pulmonary infection after stroke admitted to our hospital from May 2020 to May 2021 were randomly divided into the intervention group and control group, with 36 patients in each group. Both groups were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. The traditional Chinese medicine (TCM) syndrome score and clinical pulmonary infection score (CPIS) before and after treatment, time of fever relieving, time for the disappearance of cough, expectoration and moist rales in the lung, white blood cell count (WBC), serum C-reactive protein (CRP) level, calcitonin (PCT) level and pulmonary indexes were compared between the 2 groups, respectively, to evaluate clinical efficacy.
- Conditions
- Stroke, Lung Diseases
- Being tested
- TCM acupuncture therapy, Conventional drug therapy, Rehabilitation therapy, Breathing training
- Keywords
- Acupuncture therapy, Respiratory training, Seroinflammatory factors, Lung function
- Medical subject headings
- Stroke, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM acupuncture therapyDevice
TCM acupuncture therapy: Zusanli, Quchi, Hegu, Taichong, Feishu and Fenglong were selected as the main acupoints, and the auxiliary acupoints were selected according to the symptoms, including Fengchi, Dazhui, Lieque, Tiantu, Shenshu, Zhongfu, etc.
Conventional drug therapyDrug
Antibiotics were selected based on drug sensitivity test results. Patients with body temperature > 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided.
Rehabilitation therapyBehavioural
Comprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w.
Breathing trainingBehavioural
Training was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time.
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training Receives: Device: TCM acupuncture therapy; Drug: Conventional drug therapy; Behavioral: Rehabilitation therapy; Behavioral: Breathing training |
| the control group | Active comparator | Conventional drug therapy Rehabilitation therapy Breathing training Receives: Drug: Conventional drug therapy; Behavioral: Rehabilitation therapy; Behavioral: Breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum inflammatory factors：C-reactive protein (CRP) level
C-reactive protein (CRP) level(mg/L)
Measured: 2 Weeks
Serum inflammatory factors：Calcitonin (PCT) level
Calcitonin (PCT) level(ng/mL)
Measured: 2 Weeks
Serum inflammatory factors：WBC
WBC (x 109/L)
Measured: 2 Weeks
Improvement time for symptoms and signs of pulmonary infection：Time of fever relieving
the time for body temperature to return to normal (d)
Measured: 2 Weeks
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of cough
the time for the disappearance of cough (d)
Measured: 2 Weeks
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of expectoration
the time for the disappearance of expectoration (d)
Measured: 2 Weeks
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of moist rales
the time for the disappearance of moist rales (d)
Measured: 2 Weeks
TCM syndrome score
Before and after treatment, TCM syndrome scores were counted in the two groups. The main and secondary symptoms were classified into 4 levels, with scores of 0, 1, 2 and 3 based on the severity of the symptoms. The tongue coating and pulse pattern were scored into 2 levels, with no scored as 0 and yes as 1. The sum of various scores was calculated as the total score, with a score range of 0-36. The higher the score, the severer the condition.
Measured: 2 Weeks
Clinical pulmonary infection score (CPIS)
Before and after treatment, the 2 groups were scored comprehensively based on the average range of 12-h body temperature, WBC range, amount and character of tracheal secretions, index of gas exchange, pulmonary infiltration shadow of X-ray chest film, and pathogenic bacteria in sputum culture. According to the severity, they were divided into 3 levels, with a score of 0, 1 and 2. The maximum score was 12. The higher the score, the severer the infection.
Measured: 2 Weeks
Pulmonary indexes:forced vital capacity (FVC)
To measure the forced vital capacity (FVC)(L) before and after treatment
Measured: 2 Weeks
Pulmonary indexes:forced expiratory volume in the first second (FEV1)
To measure the forced expiratory volume in the first second (FEV1)(L/S) before and after treatment
Measured: 2 Weeks
Pulmonary indexes: peak expiratory flow (PEF)
To measure the peak expiratory flow (PEF)(L/S) before and after treatment
Measured: 2 Weeks
Efficacy evaluation:Number of patients with clinical efficacy（Cured，Effective，Remarkably effective，Invalid）
Efficacy was evaluated according to the Criteria of Diagnosis and Therapeutic Effect of Diseases and Symptoms in Traditional Chinese Medicine . Cured: Clinical adverse symptoms such as cough, expectoration and chest tightness disappeared, inflammation was absorbed on X-ray or CT, and routine blood indexes were normal. Remarkably effective: Adverse symptoms such as cough, expectoration and chest tightness were improved significantly, and X-ray or CT and routine blood test results basically returned to normal. Effective: Clinical adverse symptoms such as cough, expectoration and chest tightness were relieved, and X-ray or CT and routine blood test results were improved partially. Invalid: Clinical adverse symptoms such as cough, expectoration and chest tightness had no changes or aggravated.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 May 2020
- Primary completion31 May 2021
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WangHonglian, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930262
- Sponsor's protocol ID
- ACS002
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated With Pulmonary Infection: A Clinical Study
- ClinicalTrials.gov ID
- NCT05930262
- Acronym / sponsor ID
- ACS002
- Conditions
- Stroke, Lung Diseases
- Keywords
- Acupuncture therapy, Respiratory training, Seroinflammatory factors, Lung function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 5 Jul 2023 (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.
The goal of this prospective randomized controlled study is to explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. The intervention group and control group were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. To evaluate the clinical efficacy of both groups.
Detailed description
To explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. Using a prospective randomized controlled study, 72 patients with pulmonary infection after stroke admitted to our hospital from May 2020 to May 2021 were randomly divided into the intervention group and control group, with 36 patients in each group. Both groups were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. The traditional Chinese medicine (TCM) syndrome score and clinical pulmonary infection score (CPIS) before and after treatment, time of fever relieving, time for the disappearance of cough, expectoration and moist rales in the lung, white blood cell count (WBC), serum C-reactive protein (CRP) level, calcitonin (PCT) level and pulmonary indexes were compared between the 2 groups, respectively, to evaluate clinical efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Device: TCM acupuncture therapy, Drug: Conventional drug therapy, Behavioral: Rehabilitation therapy, Behavioral: Breathing trainingTCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training |
| the control group | Active comparator | Drug: Conventional drug therapy, Behavioral: Rehabilitation therapy, Behavioral: Breathing trainingConventional drug therapy Rehabilitation therapy Breathing training |
Who may qualify
- Ages
- 28 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meeting the diagnostic criteria of Western medicine for stroke complicated with pneumonia
- conforming to the TCM syndrome of vital qi deficiency and phlegm-heat obstructing the lung
- confirmed as the initial onset of stroke through CT or magnetic resonance imaging (MRI)
- clear consciousness, no cognitive impairment, and ability to cooperate with pulmonary function assessment and rehabilitation training
- willingness to participate in this study and sign the informed consent
Key exclusion criteria (6 listed)
- Patients with systemic multi-organ failure such as the heart, brain, kidney, etc
- patients with a coronary metal stent or pacemaker implantation
- patients with malignant tumors
- patients with severe cognitive impairment, depression or mental disorders
- patients with pulmonary infections before stroke or caused by other causes
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 |
|---|---|---|
| TCM acupuncture therapyTCM acupuncture therapy: Zusanli, Quchi, Hegu, Taichong, Feishu and Fenglong were selected as the main acupoints, and the auxiliary acupoints were selected according to the symptoms, including Fengchi, Dazhui, Lieque, Tiantu, Shenshu, Zhongfu, etc. | Device | the intervention group |
| Conventional drug therapyAntibiotics were selected based on drug sensitivity test results. Patients with body temperature > 38.5℃ were treated with physical cooling and antipyretic drugs. In patients whose sputum was thick and difficult to cough up, nebulization and inhalation therapy was given, as well as effective coughing and patting the back to expel phlegm were guided. | Drug | the control group, the intervention group |
| Rehabilitation therapyComprehensive training for hemiplegic limbs included a joint range of motion training, bridging exercise, turnover training, balance training, gait training, hand function training and self-care ability training, 40 min/d, 6 times/w. | Behavioural | the control group, the intervention group |
| Breathing trainingTraining was conducted daily in the morning, or after symptom relief in the case of fever or other discomforts, once a day, 30-40 min/time. | Behavioural | the control group, the intervention group |
Primary outcome
Serum inflammatory factors：C-reactive protein (CRP) level
Time frame: 2 Weeks
C-reactive protein (CRP) level(mg/L)
Serum inflammatory factors：Calcitonin (PCT) level
Time frame: 2 Weeks
Calcitonin (PCT) level(ng/mL)
Serum inflammatory factors：WBC
Time frame: 2 Weeks
WBC (x 109/L)
Improvement time for symptoms and signs of pulmonary infection：Time of fever relieving
Time frame: 2 Weeks
the time for body temperature to return to normal (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of cough
Time frame: 2 Weeks
the time for the disappearance of cough (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of expectoration
Time frame: 2 Weeks
the time for the disappearance of expectoration (d)
Improvement time for symptoms and signs of pulmonary infection：Time for the disappearance of moist rales
Time frame: 2 Weeks
the time for the disappearance of moist rales (d)
TCM syndrome score
Time frame: 2 Weeks
Before and after treatment, TCM syndrome scores were counted in the two groups. The main and secondary symptoms were classified into 4 levels, with scores of 0, 1, 2 and 3 based on the severity of the symptoms. The tongue coating and pulse pattern were scored into 2 levels, with no scored as 0 and yes as 1. The sum of various scores was calculated as the total score, with a score range of 0-36. The higher the score, the severer the condition.
Clinical pulmonary infection score (CPIS)
Time frame: 2 Weeks
Before and after treatment, the 2 groups were scored comprehensively based on the average range of 12-h body temperature, WBC range, amount and character of tracheal secretions, index of gas exchange, pulmonary infiltration shadow of X-ray chest film, and pathogenic bacteria in sputum culture. According to the severity, they were divided into 3 levels, with a score of 0, 1 and 2. The maximum score was 12. The higher the score, the severer the infection.
Pulmonary indexes:forced vital capacity (FVC)
Time frame: 2 Weeks
To measure the forced vital capacity (FVC)(L) before and after treatment
Pulmonary indexes:forced expiratory volume in the first second (FEV1)
Time frame: 2 Weeks
To measure the forced expiratory volume in the first second (FEV1)(L/S) before and after treatment
Pulmonary indexes: peak expiratory flow (PEF)
Time frame: 2 Weeks
To measure the peak expiratory flow (PEF)(L/S) before and after treatment
Efficacy evaluation:Number of patients with clinical efficacy（Cured，Effective，Remarkably effective，Invalid）
Time frame: 2 Weeks
Efficacy was evaluated according to the Criteria of Diagnosis and Therapeutic Effect of Diseases and Symptoms in Traditional Chinese Medicine . Cured: Clinical adverse symptoms such as cough, expectoration and chest tightness disappeared, inflammation was absorbed on X-ray or CT, and routine blood indexes were normal. Remarkably effective: Adverse symptoms such as cough, expectoration and chest tightness were improved significantly, and X-ray or CT and routine blood test results basically returned to normal. Effective: Clinical adverse symptoms such as cough, expectoration and chest tightness were relieved, and X-ray or CT and routine blood test results were improved partially. Invalid: Clinical adverse symptoms such as cough, expectoration and chest tightness had no changes or aggravated.
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 5 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM acupuncture therapy, Conventional drug therapy and Rehabilitation therapy in people with Stroke and Lung Diseases, run by The Second Hospital of Hebei Medical University at 1 site in China.
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 5 inclusion and 6 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 5 Jul 2023. 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 China. 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?
Serum inflammatory factors：C-reactive protein (CRP) level (time frame: 2 Weeks). The study lists 13 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 5 Jul 2023.