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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of health education | Placebo Comparator |
| |
| Group of health education and rehabilitation exercise | Active Comparator |
| |
| Group of health education,exercise and ONS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nutritional supplements | Dietary Supplement | oral nutritional supplements, 400-600kcal/day; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Anthropometry | three months |
| Fat free mass | Anthropometry | three months |
| Fat mass | Anthropometry | three months |
| Muscle mass | Anthropometry | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Grip strength | Muscle strength | three months |
| 6MWD | Muscle endurance strength | three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Zong, MD | Contact | +86 13524018935 | zmmlily@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Chen, PhD | Huadong Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huadong Hospital Affiliated to Fudan University | Recruiting | Shanghai | 200040 | China |
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| rehabilitation exercise | Behavioral | Aerobic exercise: fixed cycling in rehabilitation center or walking at home, 3-5 times/week, Resistance exercise: lift dumbbell by upper limb, raise legs tying sandbags, 2-3 times/week |
|
| health education | Other | Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos |
|
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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