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

• Sponsor: Houmei SHEN (Other)
• Overall Status: Completed
• CT.gov ID: NCT05986448
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Behavioral: Tai-chi exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Feb 1, 2022
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: Jan 2, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. BODE index [Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.]

   Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)

2. 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

1. 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.]

2. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anqing Hospital Affiliated to Anhui Medical University	Anqing	Anhui	China

Sponsors and Collaborators

• Houmei SHEN

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Houmei SHEN, Senior nursing officer, Department of Emergency Medicine, Anqing Hospital Affiliated to Anhui Medical University, China, Anhui Medical University
• ClinicalTrials.gov Identifier: NCT05986448
• Other Study ID Numbers: 2022-35
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Aug 15, 2023