Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Lung Diseases
• Intervention / Treatment: Device: TCM acupuncture therapy; Drug: Conventional drug therapy; Behavioral: Rehabilitation therapy; Behavioral: Breathing training

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Acupuncture Therapy Combined with Breathing Training for Patients with Stroke Complicated with Pulmonary Infection: A Clinical Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the intervention group; TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training	Device: TCM acupuncture therapy; 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.; Drug: Conventional drug therapy; 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.; Behavioral: Rehabilitation therapy; 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.; Behavioral: Breathing training; 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.
Active Comparator: the control group; Conventional drug therapy Rehabilitation therapy Breathing training	Drug: Conventional drug therapy; 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.; Behavioral: Rehabilitation therapy; 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.; Behavioral: Breathing training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum inflammatory factors：C-reactive protein (CRP) level	C-reactive protein (CRP) level(mg/L)	2 Weeks
Serum inflammatory factors：Calcitonin (PCT) level	Calcitonin (PCT) level(ng/mL)	2 Weeks
Serum inflammatory factors：WBC	WBC (x 109/L)	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)	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)	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)	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)	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.	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.	2 Weeks
Pulmonary indexes:forced vital capacity (FVC)	To measure the forced vital capacity (FVC)(L) before and after treatment	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	2 Weeks
Pulmonary indexes: peak expiratory flow (PEF)	To measure the peak expiratory flow (PEF)(L/S) before and after treatment	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.	2 Weeks

Collaborators and Investigators

• Sponsor: The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Lung function; Acupuncture therapy; Respiratory training; Seroinflammatory factors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Stroke; Lung Diseases
• Other Study ID Numbers: ACS002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No