Clinical trial NCT04741373: Study on Pulmonary Rehabilitation for Stable Chronic Obstructive Pulmonary Disease(COPD) Patients
Official title: Study on Pulmonary Rehabilitation Intervention Including Oral Nutritional Supplements(ONS) on Stable COPD Patients Who Are Under Nutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutritional Support
Aerobic Exercise
Respiratory Function Tests
Body Composition
Muscle Strength
Keywords: oral nutritional supplements
aerobic exercise
resistance exercise
respiratory function tests
body composition
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 supplements. Then formulate the best pulmonary rehabilitation guidance strategy according to the result of this trial.

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 hospitals. On the principle of having no statistical difference in indicators such as baseline age, Global Initiative for Chronic Obstructive Lung Disease（GOLD） staging, and medication oxygen consumption among the groups , the trial will randomly be divided into three groups: health education group, health education + upper and lower extremity exercise group, health education + upper and lower extremity exercise + oral nutritional supplements group.

A 12-week pulmonary rehabilitation clinical study will be conducted to observe the difference of outcome indicators among the three groups like nutritional status (24hr diet, body weight, body composition, albumin), pulmonary function (classification and staging), muscle strength and muscular endurance (grip strength, 6-minute walking distance(6MWD)), inflammation factors and St. George's Respiratory Questionnaire (SGRQ) score. Moreover outcome indicators after 24 weeks like patient weight, SGRQ score and GOLD staging also will be recorded for comparison.

The project will evidence-based provide effective means like nutrition and exercise for Chinese malnourished COPD patients who are at stable stage. And popular science books on pulmonary rehabilitation based on this trial will be compiled to record the best pulmonary rehabilitation guidance strategies.

Eligibility criteria: Inclusion Criteria:

1. 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%).
2. 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.
3. 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.
4. Malnutrition criteria: Mini Nutritional Assessment-ShortForm(MNA-SF) ≤ 12 points; or Body Mass Index(BMI) ≤ 21kg/m2.
5. Volunteers have the ability to complete the test of lung function, grip strength, 6MWD, body composition and blood index tests.

Exclusion Criteria:

1. 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 .
2. Patients have ischemic heart disease with a history of angina pectoris, or uncontrolled chest tightness and angina pectoris after activities recently.
3. Patients have severe pulmonary hypertension or grade IV by heart function grade of New York Heart Association(NYHA).
4. Arterial oxygen saturation (SpO2) \<88% or PaCO2\> 55mmHg in a quiet state.
5. Those whose life cycle is expected to be less than 6 months.
6. Walking restriction is limited in 300m because of intermittent claudication caused by peripheral arterial disease or osteoporosis.
7. Patients lost capability of autonomous activity or have cognitive impairment.

Primary outcomes:
measure: Weight
timeFrame: three months
measure: Fat free mass
timeFrame: three months
measure: Fat mass
timeFrame: three months
measure: Muscle mass
timeFrame: three months
Secondary outcomes:
measure: Grip strength
timeFrame: three months
measure: 6MWD
timeFrame: three months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
Study officials:
affiliation: Huadong Hospital
name: Jie Chen, PhD
role: STUDY_DIRECTOR
References: