Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

NCT05930262 | Completed

• 1 other identifier: ACS002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Lung Diseases

Keywords

Acupuncture therapy; Respiratory training; Seroinflammatory factors; Lung function

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

the intervention group

EXPERIMENTAL

TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training

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

Drug: Conventional drug therapy; Behavioral: Rehabilitation therapy; Behavioral: Breathing training

Interventions

TCM acupuncture therapy DEVICE

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.

the intervention group

Conventional drug therapy DRUG

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.

the control group; the intervention group

Rehabilitation therapy BEHAVIORAL

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.

the control group; the intervention group

Breathing training BEHAVIORAL

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.

the control group; the intervention group

Eligibility Criteria

• Age: 28 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

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

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Stroke; Lung Diseases

Interventions

Rehabilitation; Breathing Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 5, 2023
• Study Start: May 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: June 1, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

CN (1)