Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With AECOPD

Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and Malnutrition: a Multicenter Randomized Controlled Trial

The goal of this clinical trial is to learn about the therapeutic effect of Chinese traditional exercise Tai Chi in elderly acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with malnutrition. The main questions it aims to answer are:

1. Improvement of pulmonary function in patients with Tai Chi exercise;
2. Improvement of pulmonary function in patients with Tai Chi exercise.

The patients in control group were given routine nursing care model, including:

1. Providing basic nursing care and protection for patients according to their needs, paying attention to the care of patients' airways, and providing relevant protection and auxiliary interventions according to the needs of patients when carrying out nebulized inhalation interventions;
2. Customized nutritional supplementation recipes by specialists in clinical nutrition, giving high-protein and low-carbohydrate diets, and giving enteral or parenteral nutritional support to those who have insufficient food intake through the mouth;
3. Carrying out health education and psychological care to alleviate the patients' psychological burdens.

On the basis of the routine care model of the control group, a Tai Chi training program was developed in Tai Chi group. Tai Chi training lasted for a total of 6 months, with 4 training sessions scheduled per week, each session lasting about 40 minutes. Experts from Anqing Tai Chi Association were invited to guide the training. The training program consists of a 5-minute pre-training warm-up, a 30-minute Tai Chi exercise, and a 5-minute post-training stretching session. The Tai Chi training was done at a moderate intensity, with the heart rate limited to 60%~80% of the maximal heart rate, where:

maximal heart rate=220-age. Accelerometers were worn for each member to record heart rate changes during training, and when the heart rate exceeded the standard range, the exercise intensity could be adjusted to keep the heart rate within a reasonable range.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Behavioral: Tai-chi exercise

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Anqing, Anhui, China
      • Anqing Hospital Affiliated to Anhui Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. ≥60 and ≤85 years of age;
2. Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria;
3. Patients admitted to the hospital for treatment of chronic, repetitive coughing and severe dyspnea;
4. NRS-2002 Nutritional Risk Screening Scale score ≧3, suggesting malnutrition;
5. Conscious, able to perform normal verbal communication and without motor dysfunction

Exclusion Criteria:

1. People with impaired consciousness or invasive mechanical ventilation who were unable to fully understand and cooperate with the experiment;
2. People with active tuberculosis, lung cancer, asthma and other diseases limiting ventilation;
3. People with impaired motor function;
4. People with serious life-threatening diseases of other systems and malignant tumors;
5. People with heart failure (NYHA stage IV).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tai-chi group; Basic care measures and Tai-chi exercise	Behavioral: Tai-chi exercise; Traditional Chinese Tai Chi Movement
No Intervention: control group; Basic care measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BODE index	Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)	Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.
Plasma total protein		Measurements of plasma total protein will be taken prior to the start of the trial and at 6 months after the start of the trial.

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma albumin	Measurements of plasma albumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
Plasma prealbumin	Measurements of plasma prealbumin will be taken prior to the start of the trial and at 6 months after the start of the trial.

Collaborators and Investigators

• Sponsor: Houmei SHEN

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 2, 2023

Study Registration Dates

• First Submitted: July 22, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2022-35

Drug and device information, study documents

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