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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
probiotic supplementation will be administered, while participants continue undergoing routine pulmonary rehabilitation therapy
undergo routine pulmonary rehabilitation without probiotics intervention
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, Taiwan
RECRUITINGinterleukin-6
inflammation evaluation
Time frame: six weeks
indirect calorimetry
nutrition status
Time frame: six weeks
body composition analysis
nutrition status
Time frame: six weeks
heart rate
physiological parameters
Time frame: six weeks
saturation
physiological parameters
Time frame: six weeks
systolic and diastolic pressure
physiological parameters
Time frame: six weeks
respiratory rate
physiological parameters
Time frame: six weeks
six minute walk test
functional performance
Time frame: six weeks
time up and go
functional performance
Time frame: six weeks
FEV1
functional performance
Time frame: six weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
60
FVC
functional performance
Time frame: six weeks
FEV1/FVC
functional performance
Time frame: six weeks
CRP
biochemical blood tests
Time frame: six weeks
TNF-α
biochemical blood tests
Time frame: six weeks
TMAO
biochemical blood tests
Time frame: six weeks
The MDA of oxidative stress
biochemical blood tests
Time frame: six weeks
modified medical research council
self-perception questionnaire, maximun 4 and minimum 0, lower means a better outcome
Time frame: six weeks
COPD assessment test
self-perception questionnaire, maximun 40 and minimum 0, lower means a better outcome
Time frame: six weeks
Borg dyspnea scale
self-perception questionnaire, maximun 10 and minimum 0, lower means a better outcome
Time frame: six weeks