Nutritional SupportNCT04741373
Study on Pulmonary Rehabilitation for Stable Chronic Obstructive Pulmonary Disease(COPD) Patients
A study testing oral nutritional supplements, rehabilitation exercise and health education in people with Nutritional Support and Aerobic Exercise, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Nutritional Support, Aerobic Exercise, Respiratory Function Tests
- What is being tested?
- oral nutritional supplements, rehabilitation exercise and health education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huadong Hospital Affiliated to Fudan University
Shanghai, 200040
Jiang Wu, PhD
Jianqin Sun, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- oral nutritional supplements, rehabilitation exercise, health education
- Keywords
- oral nutritional supplements, aerobic exercise, resistance exercise, respiratory function tests, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplementsDietary supplement
oral nutritional supplements, 400-600kcal/day;
rehabilitation exerciseBehavioural
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 educationOther
Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos
| Study group | Role | What they receive |
|---|---|---|
| Group of health education | Placebo comparator | Not described Receives: Other: health education |
| Group of health education and rehabilitation exercise | Active comparator | Not described Receives: Behavioral: rehabilitation exercise; Other: health education |
| Group of health education,exercise and ONS | Experimental | Not described Receives: Dietary Supplement: oral nutritional supplements; Behavioral: rehabilitation exercise; Other: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Anthropometry
Measured: three months
Fat free mass
Anthropometry
Measured: three months
Fat mass
Anthropometry
Measured: three months
Muscle mass
Anthropometry
Measured: three months
Secondary outcomes (2)
Grip strength
Muscle strength
Measured: three months
6MWD
Muscle endurance strength
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional SupportStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Jie Chen, PhD, Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741373
- Sponsor's protocol ID
- Huadong Hospital to Fudan
- Status last verified
- Apr 2021
- First submitted
- 3 Feb 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Pulmonary Rehabilitation Intervention Including Oral Nutritional Supplements(ONS) on Stable COPD Patients Who Are Under Nutrition
- ClinicalTrials.gov ID
- NCT04741373
- Acronym / sponsor ID
- Huadong Hospital to Fudan
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral nutritional supplementsoral nutritional supplements, 400-600kcal/day; | Dietary supplement | Group of health education,exercise and ONS |
| rehabilitation exerciseAerobic 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 | Behavioural | Group of health education and rehabilitation exercise, Group of health education,exercise and ONS |
| health educationEstablish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos | Other | Group of health education, Group of health education and rehabilitation exercise, Group of health education,exercise and ONS |
Primary outcome
Weight
Time frame: three months
Anthropometry
Fat free mass
Time frame: three months
Anthropometry
Fat mass
Time frame: three months
Anthropometry
Muscle mass
Time frame: three months
Anthropometry
2 secondary outcomes
Grip strength
Time frame: three months
6MWD
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Chen, PhD study director
Huadong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nutritional supplements, rehabilitation exercise and health education in people with Nutritional Support and Aerobic Exercise, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Zong, MD (+86 13524018935, zmmlily@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.