NCT04741373

Study on Pulmonary Rehabilitation for Stable Chronic Obstructive Pulmonary Disease(COPD) Patients

Study on Pulmonary Rehabilitation Intervention Including Oral Nutritional Supplements(ONS) on Stable COPD Patients Who Are Under Nutrition

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nutritional Support
• Aerobic Exercise
• Respiratory Function Tests
• Body Composition
• Muscle Strength

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral nutritional supplements	oral nutritional supplements, 400-600kcal/day;
BEHAVIORAL	rehabilitation exercise	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
OTHER	health education	Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2021-02-05
• Last updated: 2021-04-13

Locations

1 site across 1 country: China