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

NCT04741373 | Unknown

• 1 other identifier: Huadong Hospital to Fudan
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Weight

  Anthropometry

  three months

• Fat free mass

  Anthropometry

  three months

• Fat mass

  Anthropometry

  three months

• Muscle mass

  Anthropometry

  three months

Secondary Outcomes (2)

• Grip strength

  three months

• 6MWD

  three months

Study Arms (3)

Group of health education

PLACEBO COMPARATOR

Other: health education

Group of health education and rehabilitation exercise

ACTIVE COMPARATOR

Behavioral: rehabilitation exercise; Other: health education

Group of health education,exercise and ONS

EXPERIMENTAL

Dietary Supplement: oral nutritional supplements; Behavioral: rehabilitation exercise; Other: health education

Interventions

oral nutritional supplements DIETARY_SUPPLEMENT

oral nutritional supplements, 400-600kcal/day;

Group of health education,exercise and ONS

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

Group of health education and rehabilitation exercise; Group of health education,exercise and ONS

health education OTHER

Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos

Group of health education; Group of health education and rehabilitation exercise; Group of health education,exercise and ONS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong Hospital Affiliated to Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Interventions

Dietary Supplements; Exercise Therapy

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jie Chen, PhD

  Huadong Hospital

  STUDY DIRECTOR

Central Study Contacts

Min Zong, MD

CONTACT

+86 13524018935; zmmlily@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 5, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)