NCT05240989

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

June 8, 2021

Last Update Submit

October 24, 2022

Conditions

Keywords

pulmonary rehabilitationnegative pressure ventilationelectrical cardiometrychronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • mMRC (Modified Medical Research Council) Dyspnea Scale Dyspnea Scale

    one year

  • Chronic Respiratory Disease Questionnaire

    one year

  • COPD Assessment Test

    one year

Interventions

one-year regular lung rehabilitation treatment and control the intensive monitoring of hemodynamic parameters

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of Affiliated University Hospital

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24838809BACKGROUND
  • 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.

    PMID: 31468061BACKGROUND
  • 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.

    PMID: 27741132BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ke-Yun Chao, M.Sc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leader of Respiratory Therapist

Study Record Dates

First Submitted

June 8, 2021

First Posted

February 15, 2022

Study Start

October 22, 2021

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations