Clinical trial NCT05240989: Correlation Between Pulmonary Rehabilitation and TFC
Official title: Correlation Between Pulmonary Rehabilitation and Thoracic Fluid Capacity: One-year Follow-up of Observation Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Received PR
Keywords: pulmonary rehabilitation
negative pressure ventilation
electrical cardiometry
chronic obstructive pulmonary disease
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of Affiliated University Hospital

Brief summary: To study the effects of lung rehabilitation on the heart's hemodynamic performance of patients with chronic bidirectional lung disease when performing routine and regular PR, and found that the effects of lung rehabilitation on the heart mechanism and patients long-term quality of life research.

Detailed description: This study will be conducted in the Pulmonary Rehabilitation Treatment Room on the 6th floor of the Affiliated University Hospital. The acceptance conditions are: (1) treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic, and (2) signing of the subject's consent; exclusion conditions: (1) tracheostomized patients, (2) patients who cannot perform conventional lung rehabilitation, (3) patients who use respirators at home.

The study is a prospective observational study. It is expected to include a total of 25 subjects. The study will be implemented for one year from the date of IRB adoption. Before performing PR treatment, performed the 6th and 12th Every month, routine lung function, six-minute walking tests, and non-invasive cardiac output measurements are performed. The main results are: cardiac hemodynamic parameters.

Eligibility criteria: Inclusion Criteria:

* treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic
* signing of the subject's consent

Exclusion Criteria:

* gas-cut patients
* patients who cannot perform conventional lung rehabilitation
* patients who use respirators at home

Primary outcomes:
measure: cardiac hemodynamic parameters
timeFrame: one year
measure: cardiac hemodynamic parameters
timeFrame: one year
measure: cardiac hemodynamic parameters
timeFrame: one year
measure: cardiac hemodynamic parameters
timeFrame: one year
measure: cardiac hemodynamic parameters
timeFrame: one year
Secondary outcomes:
measure: mMRC (Modified Medical Research Council) Dyspnea Scale Dyspnea Scale
timeFrame: one year
measure: Chronic Respiratory Disease Questionnaire
timeFrame: one year
measure: COPD Assessment Test
timeFrame: one year
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
References:
citation: Farias CC, Resqueti V, Dias FA, Borghi-Silva A, Arena R, Fregonezi GA. Costs and benefits of pulmonary rehabilitation in chronic obstructive pulmonary disease: a randomized controlled trial. Braz J Phys Ther. 2014 Mar-Apr;18(2):165-73. doi: 10.1590/s1413-35552012005000151. Epub 2014 May 2.
citation: Peng DM, Zampi JD, Smith SM, Yu S, Rottach N, Lowery R, Lim HM, Riegger LQ, Schumacher KR, Rocchini A. Acute Hemodynamic Effects of Negative Extrathoracic Pressure in Fontan Physiology. Pediatr Cardiol. 2019 Dec;40(8):1633-1637. doi: 10.1007/s00246-019-02197-x. Epub 2019 Aug 29.
citation: Huang HY, Chou PC, Joa WC, Chen LF, Sheng TF, Lin HC, Yang LY, Pan YB, Chung FT, Wang CH, Kuo HP. Pulmonary rehabilitation coupled with negative pressure ventilation decreases decline in lung function, hospitalizations, and medical cost in COPD: A 5-year study. Medicine (Baltimore). 2016 Oct;95(41):e5119. doi: 10.1097/MD.0000000000005119.