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This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.
Background: Patients with chronic obstructive pulmonary disease (COPD) often suffer from malnutrition and weight loss, which negatively impact mortality rates. Research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in COPD. Malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. Nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in COPD patients.
Study Design: This is a one-year, single-center, prospective randomized controlled trial.
Methods: This study is a randomized controlled trial targeting COPD patients undergoing pulmonary rehabilitation. The plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. The study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. Data will be analyzed using SPSS, with statistical significance set at p < 0.05.
Effect: The trial expects that COPD patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance.
Key words: Chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic group | Experimental | receive probiotics alongside standard pulmonary rehabilitation therapy |
|
| pulmonary rehabilitation group | Active Comparator | undergo only the standard pulmonary rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic supplementation intervention | Other | probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| interleukin-6 | inflammation evaluation | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| indirect calorimetry | nutrition status | six weeks |
| body composition analysis | nutrition status | six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ke-Yun Chao, PhD | Contact | +886-905-301-879 | C00152@mail.fjuh.fju.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ke-Yun Chao, PhD | Fu Jen Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Jen Catholic University Hospital, Fu Jen Catholic University | Recruiting | New Taipei City | 24352 | Taiwan |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| standard pulmonnary rehabilitation | Other | undergo routine pulmonary rehabilitation without probiotics intervention |
|
| heart rate | physiological parameters | six weeks |
| saturation | physiological parameters | six weeks |
| systolic and diastolic pressure | physiological parameters | six weeks |
| respiratory rate | physiological parameters | six weeks |
| six minute walk test | functional performance | six weeks |
| time up and go | functional performance | six weeks |
| FEV1 | functional performance | six weeks |
| FVC | functional performance | six weeks |
| FEV1/FVC | functional performance | six weeks |
| CRP | biochemical blood tests | six weeks |
| TNF-α | biochemical blood tests | six weeks |
| TMAO | biochemical blood tests | six weeks |
| The MDA of oxidative stress | biochemical blood tests | six weeks |
| modified medical research council | self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome | six weeks |
| COPD assessment test | self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome | six weeks |
| Borg dyspnea scale | self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome | six weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |