Construction and Application of Early Lung Rehabilitation Training Programs

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04912986

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is intended to construct early lung rehabilitation training programs for adult patients after double lung transplantation, including safety assessment, exercise training, respiratory function training, psychological support and health education, with a view to helping double lung transplant patients achieve lung rehabilitation at an early date, improve patients' motor endurance and respiratory function, and improve the quality of near- and long-term survival.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Transplantation	Behavioral: Early Lung Rehabilitation Training Behavioral: Routine treatment	N/A

Detailed Description

The first stage constructs the lung rehabilitation program, and the second stage implements the non-contemporaneous study control trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Construction and Application of Early Lung Rehabilitation Training Programs for Adult Patients After Double Lung Transplantation

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: routine treatment Review the collection of patient-related clinical data, collation of clinical data and outcome indicators	Behavioral: Routine treatment Provide rehabilitation training as usual, without standard program
Experimental: Experimental group The intervention was implemented in accordance with the Early Lung Rehabilitation Training Programme for Adult Double Lung Transplant Patients	Behavioral: Early Lung Rehabilitation Training It is implemented in accordance with the Early Lung Rehabilitation Training Program for Adult Double Lung Transplant Patients. Establish multidisciplinary collaboration teams, including competent doctors, nurses, rehabilitation physicians, and psychologists.

Arm

Intervention/Treatment

Placebo Comparator: routine treatment

Review the collection of patient-related clinical data, collation of clinical data and outcome indicators

Behavioral: Routine treatment

Provide rehabilitation training as usual, without standard program

Experimental: Experimental group

The intervention was implemented in accordance with the Early Lung Rehabilitation Training Programme for Adult Double Lung Transplant Patients

Behavioral: Early Lung Rehabilitation Training

It is implemented in accordance with the Early Lung Rehabilitation Training Program for Adult Double Lung Transplant Patients. Establish multidisciplinary collaboration teams, including competent doctors, nurses, rehabilitation physicians, and psychologists.

Outcome Measures

Primary Outcome Measures

Mechanical ventilation time [1 year]
The time for mechanical ventilation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age ≥ 18 years
consent to early lung rehabilitation
informed consent to this study.

Exclusion Criteria:

Unstable condition, not allowed to receive pulmonary rehabilitation treatment
A person with a mental disorder who cannot cooperate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SAHZhejiangU	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Jiangshuyuan Liang, Master, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04912986

Other Study ID Numbers:

2021-0232

First Posted:

Jun 3, 2021

Last Update Posted:

Jun 3, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

pulmonary transplantation

pulmonory rehabilitation

Study Results

No Results Posted as of Jun 3, 2021