Evaluation of Skeletal Muscle Function Using Ultrasonic Elastography

NCT05805332 | Unknown

• 1 other identifier: 2022-NHLHCRF-LX-01-0202-4
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Forced Expiratory Volume in 1-second(FEV1)

  before pulmonary rehabilitation

• Forced Expiratory Volume in 1-second(FEV1)

  1 week after pulmonary rehabilitation

• Ultrasonic elastic imaging of rectus femoris

  before pulmonary rehabilitation

• Ultrasonic elastic imaging of rectus femoris

  1 week after pulmonary rehabilitation

Study Arms (1)

pulmonary rehabilitation

Other: pulmonary rehabilitation

Interventions

pulmonary rehabilitation OTHER

The participants would undergo pulmonary rehabilitation.

pulmonary rehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic obstructive pulmonary disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mingming Deng, MD

CONTACT

86 18801336854; isdeng1017@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 10, 2023
• Study Start: April 7, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-04