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Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

Primary Purpose

Stroke, Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TCM acupuncture therapy
Conventional drug therapy
Rehabilitation therapy
Breathing training
Sponsored by
The Second Hospital of Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Acupuncture therapy, Respiratory training, Seroinflammatory factors, Lung function

Eligibility Criteria

28 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the intervention group

the control group

Arm Description

TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training

Conventional drug therapy Rehabilitation therapy Breathing training

Outcomes

Primary Outcome Measures

Serum inflammatory factors:C-reactive protein (CRP) level
C-reactive protein (CRP) level(mg/L)
Serum inflammatory factors:Calcitonin (PCT) level
Calcitonin (PCT) level(ng/mL)
Serum inflammatory factors:WBC
WBC (x 109/L)
Improvement time for symptoms and signs of pulmonary infection:Time of fever relieving
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
the time for the disappearance of cough (d)
Improvement time for symptoms and signs of pulmonary infection:Time for the disappearance of expectoration
the time for the disappearance of expectoration (d)
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)
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.
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.
Pulmonary indexes:forced vital capacity (FVC)
To measure the forced vital capacity (FVC)(L) before and after treatment
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
Pulmonary indexes: peak expiratory flow (PEF)
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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
June 25, 2023
Sponsor
The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05930262
Brief Title
Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated
Official Title
Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated With Pulmonary Infection: A Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Lung Diseases
Keywords
Acupuncture therapy, Respiratory training, Seroinflammatory factors, Lung function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the intervention group
Arm Type
Experimental
Arm Description
TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training
Arm Title
the control group
Arm Type
Active Comparator
Arm Description
Conventional drug therapy Rehabilitation therapy Breathing training
Intervention Type
Device
Intervention Name(s)
TCM acupuncture therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Conventional drug therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breathing training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum inflammatory factors:C-reactive protein (CRP) level
Description
C-reactive protein (CRP) level(mg/L)
Time Frame
2 Weeks
Title
Serum inflammatory factors:Calcitonin (PCT) level
Description
Calcitonin (PCT) level(ng/mL)
Time Frame
2 Weeks
Title
Serum inflammatory factors:WBC
Description
WBC (x 109/L)
Time Frame
2 Weeks
Title
Improvement time for symptoms and signs of pulmonary infection:Time of fever relieving
Description
the time for body temperature to return to normal (d)
Time Frame
2 Weeks
Title
Improvement time for symptoms and signs of pulmonary infection:Time for the disappearance of cough
Description
the time for the disappearance of cough (d)
Time Frame
2 Weeks
Title
Improvement time for symptoms and signs of pulmonary infection:Time for the disappearance of expectoration
Description
the time for the disappearance of expectoration (d)
Time Frame
2 Weeks
Title
Improvement time for symptoms and signs of pulmonary infection:Time for the disappearance of moist rales
Description
the time for the disappearance of moist rales (d)
Time Frame
2 Weeks
Title
TCM syndrome score
Description
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.
Time Frame
2 Weeks
Title
Clinical pulmonary infection score (CPIS)
Description
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.
Time Frame
2 Weeks
Title
Pulmonary indexes:forced vital capacity (FVC)
Description
To measure the forced vital capacity (FVC)(L) before and after treatment
Time Frame
2 Weeks
Title
Pulmonary indexes:forced expiratory volume in the first second (FEV1)
Description
To measure the forced expiratory volume in the first second (FEV1)(L/S) before and after treatment
Time Frame
2 Weeks
Title
Pulmonary indexes: peak expiratory flow (PEF)
Description
To measure the peak expiratory flow (PEF)(L/S) before and after treatment
Time Frame
2 Weeks
Title
Efficacy evaluation:Number of patients with clinical efficacy(Cured,Effective,Remarkably effective,Invalid)
Description
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.
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

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