Construction and Application of Early Lung Rehabilitation Training Programs

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Transplantation
• Intervention / Treatment: Behavioral: Routine treatment; Behavioral: Early Lung Rehabilitation Training

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiangshuyuan Liang, Master; Phone Number: 13868058705; Email: 2517140@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • SAHZhejiangU
      • Contact: Fei Zeng, Bachelor; Phone Number: 13757119536; Email: zengfei@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical ventilation time	The time for mechanical ventilation	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pulmonary transplantation; pulmonory rehabilitation
• Other Study ID Numbers: 2021-0232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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