Evaluation of Skeletal Muscle Function Using Ultrasonic Elastography

Evaluation of Skeletal Muscle Function in Patients With Chronic Obstructive Pulmonary Disease Before and After Lung Rehabilitation Training Using Ultrasonic Elastography

The goal of observational study is to evaluation of skeletal muscle function in patients with chronic obstructive pulmonary disease before and after lung rehabilitation training using ultrasonic elastography in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of skeletal muscle function in patients with chronic obstructive pulmonary disease before and after lung rehabilitation training using ultrasonic elastography.

Participants will undergo pulmonary rehabilitation.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: pulmonary rehabilitation

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Mingming Deng, MD; Phone Number: 86 18801336854; Email: isdeng1017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chronic obstructive pulmonary disease

Description

Inclusion Criteria:

• The age is between 40-80 years old
• Patients with chronic obstructive pulmonary disease who meet the diagnostic criteria of GOLD guideline(2019)
• There was no acute exacerbation in the past 12 weeks

Exclusion Criteria:

• Hypoxemia (oxygen partial pressure is less than 60mmHg or oxygen saturation is less than 88% at rest), or patients who need continuous oxygen inhalation, or patients with any contraindication to exercise test (refer to the American Thoracic Association/American Association of Thoracic Physicians exercise test guidelines)
• Oral glucocorticoids
• Receive long-term oxygen therapy prescription
• Have participated in supervised exercise programs in the past 12 months
• History of other lung diseases, including pneumoconiosis, bronchiectasis, tuberculosis, primary pulmonary hypertension, pulmonary embolism, interstitial lung disease
• Diseases that restrict the active exercise ability of participants or involve skeletal, neuromuscular, cardiovascular or metabolic disorders of muscle activity, such as tumors, diabetes, muscle weakness, etc

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pulmonary rehabilitation	Other: pulmonary rehabilitation; The participants would undergo pulmonary rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of pulmonary rehabilitation training	6-minute walking distance (6MWD)	baseline
Effectiveness of pulmonary rehabilitation training	6-minute walking distance (6MWD)	1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training	COPD Assessment Test (CAT) score	baseline
Effectiveness of pulmonary rehabilitation training	COPD Assessment Test (CAT) score	1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training	St. George's Respiratory Questionnaire (SGRQ)	baseline
Effectiveness of pulmonary rehabilitation training	St. George's Respiratory Questionnaire (SGRQ)	1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training	modified Medical Research Council (mMRC) dyspnea scores	baseline
Effectiveness of pulmonary rehabilitation training	modified Medical Research Council (mMRC) dyspnea scores	1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training	rectus femoris muscle strength via a dynamometer	baseline
Effectiveness of pulmonary rehabilitation training	rectus femoris muscle strength via a dynamometer	1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training	6-30-second sit-to-stand test	baseline
Effectiveness of pulmonary rehabilitation training	6-30-second sit-to-stand test	1 week after pulmonary rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1-second(FEV1)	Pulmonary function test	before pulmonary rehabilitation
Forced Expiratory Volume in 1-second(FEV1)	Pulmonary function test	1 week after pulmonary rehabilitation
Ultrasonic elastic imaging of rectus femoris	Ultrasonic elastography of skeletal muscle	before pulmonary rehabilitation
Ultrasonic elastic imaging of rectus femoris	Ultrasonic elastography of skeletal muscle	1 week after pulmonary rehabilitation

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 7, 2023
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2022-NHLHCRF-LX-01-0202-4

Drug and device information, study documents

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