Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

NCT ID: NCT05930262

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2023-06-01

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.

Conditions

Stroke; Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

the intervention group

TCM acupuncture therapy Conventional drug therapy Rehabilitation therapy Breathing training

Group Type: EXPERIMENTAL

TCM acupuncture therapy

Intervention Type: 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.

Conventional drug therapy

Intervention Type: 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.

Rehabilitation therapy

Intervention Type: 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.

Breathing training

Intervention Type: 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

Conventional drug therapy Rehabilitation therapy Breathing training

Group Type: ACTIVE_COMPARATOR

Conventional drug therapy

Intervention Type: 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.

Rehabilitation therapy

Intervention Type: 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.

Breathing training

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

WangHonglian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

ACS002

Identifier Type: -

Identifier Source: org_study_id