Correlation Between Pulmonary Rehabilitation and TFC

Correlation Between Pulmonary Rehabilitation and Thoracic Fluid Capacity: One-year Follow-up of Observation Research

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.

Study Overview

• Status: Recruiting
• Conditions: COPD Received PR
• Intervention / Treatment: Procedure: pulmonary rehabilitation

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.

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Ke-Yun Chao, M.Sc; Phone Number: +886952909103; Email: ck_qq@hotmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Recruiting
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University
    • Contact: Ke-Yun Chao, M.Sc; Phone Number: +886952909103; Email: ck_qq@hotmail.con
    • Principal Investigator: Ke-Yun Chao, M.Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients of Affiliated University Hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac hemodynamic parameters	heart rate (HR)	one year
cardiac hemodynamic parameters	blood pressure (BP)	one year
cardiac hemodynamic parameters	stroke volume (SV)	one year
cardiac hemodynamic parameters	cardiac output (CO)	one year
cardiac hemodynamic parameters	total peripheral resistance (TPR)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mMRC (Modified Medical Research Council) Dyspnea Scale Dyspnea Scale	assessing the severity of breathlessness in patients with COPD	one year
Chronic Respiratory Disease Questionnaire	The Chronic Respiratory Disease Questionnaire (CRQ) is the most commonly used disease specific measurement tool to assess health related quality of life (HRQL) in patients with chronic respiratory disease. It examines four aspects of patients' lives: dyspnoea, fatigue, emotional function, and mastery (the feeling of control over the disease and its effects).	one year
COPD Assessment Test	measure the impact of COPD on a person's life, and how this changes over time. Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.	one year

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; chronic obstructive pulmonary disease; negative pressure ventilation; electrical cardiometry
• Other Study ID Numbers: PL-202008027-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No