Treating Frailty in Lung Transplant Candidates (PREHAB)

NCT03457545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-03-07

No results posted yet for this study

Summary

In this pilot project, 35 lung transplant candidates will be recruited to participate in a three month individualized home-based program focused on exercise and nutrition optimization. This pilot is designed to assess the feasibility of treating frailty before lung transplantation. Participants will complete a 1 day in-person assessment and training session that will include baseline frailty assessment, determination of exercise capacity, and a determination of nutritional status. Based on American Thoracic Society Guidelines and a diet evaluation by a registered dietician, information gathered during the assessment will be used to develop a tailored prescription for exercise and nutrition to be continued at home. Participants will also be taught self-management skills specific to control of dyspnea, fatigue, motivation, and support. Participants will receive training in protocol implementation at home by a coordinator trained in principles of behavior change, adult learning theory, and dyspnea control techniques. Subjects will be provided tablet computers with an app called Aidcube preloaded and taught how to interface with the app. Aidcube is a commercially available exercise platform designed for patients with lung and heart diseases. It was designed with the input of physicians, physical therapists, respiratory therapists, nutritionists who specialize in patients with lung and heart disease and adheres to professional society guidelines for exercise and rehabilitation in patients with lung disease. Subjects will then adhere to a individually tailored home exercise and nutrition program based on their exercise capacity. Aidcube allows clinicians (or in this case the PI and co-PI) the ability to design a customized program of exercises and diet plan through the "provider interface". The subjects interacts with the "patient interface" to complete their exercise program during the 8 week study intervention.

This goal of this pilot project is to determine the feasibility of implementing a home-based exercise and nutrition program with patients with advanced lung disease awaiting lung transplantation.

Information on Aidcube can be found at https://www.aidcube.com.

The overarching aim of this pilot study is preparatory investigation to evaluate the feasibility of performing a home-based intervention to treat frailty in lung transplant candidates.

Specific aims:

* Establish a sampling time frame and recruitment techniques.
* Assess willingness to participate
* Assess adherence and compliance.
* Identify logistical problems in the in-person and at-home components of the intervention
* Determine the resources needed for a full-scale study.
* Provide funding bodies evidence that research team is competent and knowledgeable.
* Provide funding bodies that the study is feasible

Conditions

  • Advanced Lung Disease

Interventions

BEHAVIORAL

Home-based pulmonary rehabilitation

Pilot study of a home-based pulmonary rehabilitation study for lung transplant candidates at the University of California San Francisco

OTHER

Aidcube

Participants will be testing and giving feedback on the use of the Aidcube platform in being able to deliver their home-exercise prescription

Sponsors & Collaborators

Principal Investigators

  • Jonathan Singer, MD, MS · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-11
Primary Completion
2017-12-14
Completion
2017-12-14

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457545 on ClinicalTrials.gov