NCT05986448

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. 1.Improvement of pulmonary function in patients with Tai Chi exercise;
  2. 2.Improvement of pulmonary function in patients with Tai Chi exercise.
  3. 3.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;
  4. 4.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;
  5. 5.Carrying out health education and psychological care to alleviate the patients' psychological burdens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

July 22, 2023

Last Update Submit

August 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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.

Study Arms (2)

Tai-chi group

EXPERIMENTAL

Basic care measures and Tai-chi exercise

Behavioral: Tai-chi exercise

control group

NO INTERVENTION

Basic care measures

Interventions

Traditional Chinese Tai Chi Movement

Tai-chi group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anqing Hospital Affiliated to Anhui Medical University

Anqing, Anhui, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior nursing officer, Department of Emergency Medicine, Anqing Hospital Affiliated to Anhui Medical University, China

Study Record Dates

First Submitted

July 22, 2023

First Posted

August 14, 2023

Study Start

February 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 2, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations