Body Composition Measurement, COPD (Chronic Obstructive Pulmonary Disease), Probiotic Intervention
Conditions
Keywords
body composition, inflammation markers, nutritional supplementation, probiotics, chronic obstructive pulmonary disease
Brief summary
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.
Detailed description
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
Interventions
probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy
undergo routine pulmonary rehabilitation without probiotics intervention
Sponsors
Fu Jen Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to sign a written informed consent form. * Diagnosed with pre-COPD or COPD stage I-IV according to the 2023 GOLD guidelines. * Undergoing pulmonary rehabilitation therapy for more than three months.
Exclusion criteria
* Under 18 years old. * Diagnosed with neuromuscular diseases. * Experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months. * Unable to cooperate with cardiopulmonary exercise testing. * Has other diseases or behavioral restrictions preventing participation in exercise training for over one year. * Assessed by a physician to have severe malnutrition or a significantly low BMI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| interleukin-6 | six weeks | inflammation evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| indirect calorimetry | six weeks | nutrition status |
| body composition analysis | six weeks | nutrition status |
| heart rate | six weeks | physiological parameters |
| saturation | six weeks | physiological parameters |
| systolic and diastolic pressure | six weeks | physiological parameters |
| respiratory rate | six weeks | physiological parameters |
| six minute walk test | six weeks | functional performance |
| time up and go | six weeks | functional performance |
| FEV1 | six weeks | functional performance |
| FVC | six weeks | functional performance |
| FEV1/FVC | six weeks | functional performance |
| CRP | six weeks | biochemical blood tests |
| TNF-α | six weeks | biochemical blood tests |
| TMAO | six weeks | biochemical blood tests |
| The MDA of oxidative stress | six weeks | biochemical blood tests |
| modified medical research council | six weeks | self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome |
| COPD assessment test | six weeks | self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome |
| Borg dyspnea scale | six weeks | self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome |
Countries
Taiwan
Contacts
CONTACTKe-Yun Chao, PhD
PRINCIPAL_INVESTIGATORKe-Yun Chao, PhD
Fu Jen Catholic University
Outcome results
None listed