Clinical trial NCT05805332: Evaluation of Skeletal Muscle Function Using Ultrasonic Elastography
Official title: Evaluation of Skeletal Muscle Function in Patients With Chronic Obstructive Pulmonary Disease Before and After Lung Rehabilitation Training Using Ultrasonic Elastography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic obstructive pulmonary disease

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: baseline
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: 1 week after pulmonary rehabilitation
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: baseline
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: 1 week after pulmonary rehabilitation
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: baseline
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: 1 week after pulmonary rehabilitation
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: baseline
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: 1 week after pulmonary rehabilitation
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: baseline
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: 1 week after pulmonary rehabilitation
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: baseline
measure: Effectiveness of pulmonary rehabilitation training
timeFrame: 1 week after pulmonary rehabilitation
Secondary outcomes:
measure: Forced Expiratory Volume in 1-second(FEV1)
timeFrame: before pulmonary rehabilitation
measure: Forced Expiratory Volume in 1-second(FEV1)
timeFrame: 1 week after pulmonary rehabilitation
measure: Ultrasonic elastic imaging of rectus femoris
timeFrame: before pulmonary rehabilitation
measure: Ultrasonic elastic imaging of rectus femoris
timeFrame: 1 week after pulmonary rehabilitation
Other outcomes:
Locations:
Study officials:
References: