Chronic Obstructive Pulmonary DiseaseNCT05805332
Evaluation of Skeletal Muscle Function Using Ultrasonic Elastography
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- pulmonary rehabilitation
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic obstructive pulmonary disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationOther
The participants would undergo pulmonary rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary rehabilitation | Not described Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of pulmonary rehabilitation training
6-minute walking distance (6MWD)
Measured: baseline
Effectiveness of pulmonary rehabilitation training
6-minute walking distance (6MWD)
Measured: 1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training
COPD Assessment Test (CAT) score
Measured: baseline
Effectiveness of pulmonary rehabilitation training
COPD Assessment Test (CAT) score
Measured: 1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training
St. George's Respiratory Questionnaire (SGRQ)
Measured: baseline
Effectiveness of pulmonary rehabilitation training
St. George's Respiratory Questionnaire (SGRQ)
Measured: 1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training
modified Medical Research Council (mMRC) dyspnea scores
Measured: baseline
Effectiveness of pulmonary rehabilitation training
modified Medical Research Council (mMRC) dyspnea scores
Measured: 1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training
rectus femoris muscle strength via a dynamometer
Measured: baseline
Effectiveness of pulmonary rehabilitation training
rectus femoris muscle strength via a dynamometer
Measured: 1 week after pulmonary rehabilitation
Effectiveness of pulmonary rehabilitation training
6-30-second sit-to-stand test
Measured: baseline
Effectiveness of pulmonary rehabilitation training
6-30-second sit-to-stand test
Measured: 1 week after pulmonary rehabilitation
Secondary outcomes (4)
Forced Expiratory Volume in 1-second(FEV1)
Pulmonary function test
Measured: before pulmonary rehabilitation
Forced Expiratory Volume in 1-second(FEV1)
Pulmonary function test
Measured: 1 week after pulmonary rehabilitation
Ultrasonic elastic imaging of rectus femoris
Ultrasonic elastography of skeletal muscle
Measured: before pulmonary rehabilitation
Ultrasonic elastic imaging of rectus femoris
Ultrasonic elastography of skeletal muscle
Measured: 1 week after pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start7 Apr 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805332
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0202-4
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skeletal Muscle Function in Patients With Chronic Obstructive Pulmonary Disease Before and After Lung Rehabilitation Training Using Ultrasonic Elastography
- ClinicalTrials.gov ID
- NCT05805332
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0202-4
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 7 Apr 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary rehabilitation | – | Other: pulmonary rehabilitation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic obstructive pulmonary disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary rehabilitationThe participants would undergo pulmonary rehabilitation. | Other | pulmonary rehabilitation |
Primary outcome
Effectiveness of pulmonary rehabilitation training
Time frame: baseline
6-minute walking distance (6MWD)
Effectiveness of pulmonary rehabilitation training
Time frame: 1 week after pulmonary rehabilitation
6-minute walking distance (6MWD)
Effectiveness of pulmonary rehabilitation training
Time frame: baseline
COPD Assessment Test (CAT) score
Effectiveness of pulmonary rehabilitation training
Time frame: 1 week after pulmonary rehabilitation
COPD Assessment Test (CAT) score
Effectiveness of pulmonary rehabilitation training
Time frame: baseline
St. George's Respiratory Questionnaire (SGRQ)
Effectiveness of pulmonary rehabilitation training
Time frame: 1 week after pulmonary rehabilitation
St. George's Respiratory Questionnaire (SGRQ)
Effectiveness of pulmonary rehabilitation training
Time frame: baseline
modified Medical Research Council (mMRC) dyspnea scores
Effectiveness of pulmonary rehabilitation training
Time frame: 1 week after pulmonary rehabilitation
modified Medical Research Council (mMRC) dyspnea scores
Effectiveness of pulmonary rehabilitation training
Time frame: baseline
rectus femoris muscle strength via a dynamometer
Effectiveness of pulmonary rehabilitation training
Time frame: 1 week after pulmonary rehabilitation
rectus femoris muscle strength via a dynamometer
Effectiveness of pulmonary rehabilitation training
Time frame: baseline
6-30-second sit-to-stand test
Effectiveness of pulmonary rehabilitation training
Time frame: 1 week after pulmonary rehabilitation
6-30-second sit-to-stand test
4 secondary outcomes
Forced Expiratory Volume in 1-second(FEV1)
Time frame: before pulmonary rehabilitation
Forced Expiratory Volume in 1-second(FEV1)
Time frame: 1 week after pulmonary rehabilitation
Ultrasonic elastic imaging of rectus femoris
Time frame: before pulmonary rehabilitation
Ultrasonic elastic imaging of rectus femoris
Time frame: 1 week after pulmonary rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of pulmonary rehabilitation training (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.