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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tai-chi exercise
Sponsored by
Houmei SHEN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥60 and ≤85 years of age; Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria; Patients admitted to the hospital for treatment of chronic, repetitive coughing and severe dyspnea; NRS-2002 Nutritional Risk Screening Scale score ≧3, suggesting malnutrition; Conscious, able to perform normal verbal communication and without motor dysfunction Exclusion Criteria: People with impaired consciousness or invasive mechanical ventilation who were unable to fully understand and cooperate with the experiment; People with active tuberculosis, lung cancer, asthma and other diseases limiting ventilation; People with impaired motor function; People with serious life-threatening diseases of other systems and malignant tumors; People with heart failure (NYHA stage IV).

Sites / Locations

  • Anqing Hospital Affiliated to Anhui Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tai-chi group

control group

Arm Description

Basic care measures and Tai-chi exercise

Basic care measures

Outcomes

Primary Outcome Measures

BODE index
Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)
Plasma total protein

Secondary Outcome Measures

Plasma albumin
Plasma prealbumin

Full Information

First Posted
July 22, 2023
Last Updated
August 12, 2023
Sponsor
Houmei SHEN
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1. Study Identification

Unique Protocol Identification Number
NCT05986448
Brief Title
Effects of Tai Chi for Early Pulmonary Rehabilitation in Elderly Patients With AECOPD
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Houmei SHEN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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: Improvement of pulmonary function in patients with Tai Chi exercise; Improvement of pulmonary function in patients with Tai Chi exercise. The patients in control group were given routine nursing care model, including: 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; 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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai-chi group
Arm Type
Experimental
Arm Description
Basic care measures and Tai-chi exercise
Arm Title
control group
Arm Type
No Intervention
Arm Description
Basic care measures
Intervention Type
Behavioral
Intervention Name(s)
Tai-chi exercise
Intervention Description
Traditional Chinese Tai Chi Movement
Primary Outcome Measure Information:
Title
BODE index
Description
Body Mass Index (B), the degree of airflow obstruction (O), dyspnea (D), exercise capacity (E)
Time Frame
Measurements of BODE index will be taken prior to the start of the trial and at 6 months after the start of the trial.
Title
Plasma total protein
Time Frame
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 Measure Information:
Title
Plasma albumin
Time Frame
Measurements of plasma albumin will be taken prior to the start of the trial and at 6 months after the start of the trial.
Title
Plasma prealbumin
Time Frame
Measurements of plasma prealbumin will be taken prior to the start of the trial and at 6 months after the start of the trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥60 and ≤85 years of age; Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria; Patients admitted to the hospital for treatment of chronic, repetitive coughing and severe dyspnea; NRS-2002 Nutritional Risk Screening Scale score ≧3, suggesting malnutrition; Conscious, able to perform normal verbal communication and without motor dysfunction Exclusion Criteria: People with impaired consciousness or invasive mechanical ventilation who were unable to fully understand and cooperate with the experiment; People with active tuberculosis, lung cancer, asthma and other diseases limiting ventilation; People with impaired motor function; People with serious life-threatening diseases of other systems and malignant tumors; People with heart failure (NYHA stage IV).
Facility Information:
Facility Name
Anqing Hospital Affiliated to Anhui Medical University
City
Anqing
State/Province
Anhui
Country
China

12. IPD Sharing Statement

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

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