Evaluation of Skeletal Muscle Function Using Ultrasonic Elastography

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05805332
• Other study ID #: 2022-NHLHCRF-LX-01-0202-4
• Status: Not yet recruiting
• Start date: April 7, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• pulmonary rehabilitation
The participants would undergo pulmonary rehabilitation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of pulmonary rehabilitation training	6-minute walking distance (6MWD)	baseline
Primary	Effectiveness of pulmonary rehabilitation training	6-minute walking distance (6MWD)	1 week after pulmonary rehabilitation
Primary	Effectiveness of pulmonary rehabilitation training	COPD Assessment Test (CAT) score	baseline
Primary	Effectiveness of pulmonary rehabilitation training	COPD Assessment Test (CAT) score	1 week after pulmonary rehabilitation
Primary	Effectiveness of pulmonary rehabilitation training	St. George's Respiratory Questionnaire (SGRQ)	baseline
Primary	Effectiveness of pulmonary rehabilitation training	St. George's Respiratory Questionnaire (SGRQ)	1 week after pulmonary rehabilitation
Primary	Effectiveness of pulmonary rehabilitation training	modified Medical Research Council (mMRC) dyspnea scores	baseline
Primary	Effectiveness of pulmonary rehabilitation training	modified Medical Research Council (mMRC) dyspnea scores	1 week after pulmonary rehabilitation
Primary	Effectiveness of pulmonary rehabilitation training	rectus femoris muscle strength via a dynamometer	baseline
Primary	Effectiveness of pulmonary rehabilitation training	rectus femoris muscle strength via a dynamometer	1 week after pulmonary rehabilitation
Primary	Effectiveness of pulmonary rehabilitation training	6-30-second sit-to-stand test	baseline
Primary	Effectiveness of pulmonary rehabilitation training	6-30-second sit-to-stand test	1 week after pulmonary rehabilitation
Secondary	Forced Expiratory Volume in 1-second(FEV1)	Pulmonary function test	before pulmonary rehabilitation
Secondary	Forced Expiratory Volume in 1-second(FEV1)	Pulmonary function test	1 week after pulmonary rehabilitation
Secondary	Ultrasonic elastic imaging of rectus femoris	Ultrasonic elastography of skeletal muscle	before pulmonary rehabilitation
Secondary	Ultrasonic elastic imaging of rectus femoris	Ultrasonic elastography of skeletal muscle	1 week after pulmonary rehabilitation