Status:
UNKNOWN
Study on Pulmonary Rehabilitation for Stable Chronic Obstructive Pulmonary Disease(COPD) Patients
Lead Sponsor:
Fudan University
Conditions:
Nutritional Support
Aerobic Exercise
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
To compare the difference of effectiveness for stable COPD patients with poor nutritional status among three groups named health education, upper and lower limb exercises, and oral nutritional supplem...
Detailed Description
This study is a clinical randomized, non-blinded, controlled study in China. The participants will be 90 stable COPD patients with poor nutritional status selected by the community or primary hospital...
Eligibility Criteria
Inclusion
- Patients with moderate and severe COPD with a clear diagnosis of lung function, (moderate-forced expiratory volume at one second（FEV1）/forced vital capacity（FVC）\<0.7, FEV1% between 50-80%; severe-FEV1/FVC\<0.7, FEV1% \< 50%).
- Patients are at stable stage of COPD which means hospital admission \<2 times due to acute exacerbation in the past two years, no changes in respiratory symptoms and medication in the past month.
- Patients have not participated in any form of pulmonary rehabilitation in the past at least 0.5 year and simultaneously have not taken any form of nutritional supplements in the past at least 2 weeks.
- Malnutrition criteria: Mini Nutritional Assessment-ShortForm(MNA-SF) ≤ 12 points; or Body Mass Index(BMI) ≤ 21kg/m2.
- Volunteers have the ability to complete the test of lung function, grip strength, 6MWD, body composition and blood index tests.
Exclusion
- Patients suffer from significant diseases which will cause the subjects to be at risk due to participating in the research, or affect the research results and the subjects' ability to participate in the research,including severe diseases of liver and kidney, nervous system, endocrine and digestive system .
- Patients have ischemic heart disease with a history of angina pectoris, or uncontrolled chest tightness and angina pectoris after activities recently.
- Patients have severe pulmonary hypertension or grade IV by heart function grade of New York Heart Association(NYHA).
- Arterial oxygen saturation (SpO2) \<88% or PaCO2\> 55mmHg in a quiet state.
- Those whose life cycle is expected to be less than 6 months.
- Walking restriction is limited in 300m because of intermittent claudication caused by peripheral arterial disease or osteoporosis.
- Patients lost capability of autonomous activity or have cognitive impairment.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04741373
Start Date
April 1 2021
End Date
September 1 2021
Last Update
April 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Huadong Hospital Affiliated to Fudan University
Shanghai, China, 200040