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

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.

Study Overview

• Status: Recruiting
• Conditions: Body Composition; Muscle Strength; Aerobic Exercise; Nutritional Support; Respiratory Function Tests
• Intervention / Treatment: Other: health education; Behavioral: rehabilitation exercise; Dietary supplement: oral nutritional supplements

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Zong, MD; Phone Number: +86 13524018935; Email: zmmlily@163.com

Study Locations

• China
  • Shanghai, China, 200040
    • Recruiting
    • Huadong Hospital affiliated to Fudan University
    • Contact: Jiang Wu, PhD
    • Principal Investigator: Jianqin Sun, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group of health education	Other: health education; Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos
Active Comparator: Group of health education and rehabilitation exercise	Other: health education; Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos; 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
Experimental: Group of health education,exercise and ONS	Other: health education; Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos; 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; Dietary supplement: oral nutritional supplements; oral nutritional supplements, 400-600kcal/day;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Anthropometry	three months
Fat free mass	Anthropometry	three months
Fat mass	Anthropometry	three months
Muscle mass	Anthropometry	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength	Muscle strength	three months
6MWD	Muscle endurance strength	three months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Director: Jie Chen, PhD, Huadong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: aerobic exercise; resistance exercise; body composition; respiratory function tests; oral nutritional supplements
• Other Study ID Numbers: Huadong Hospital to Fudan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No