The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital

Physical Activity Clinical Trial

Official title:

The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444273
• Other study ID #: 201403118
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary outcome of this study is to demonstrate the feasibility of a prehabilitation program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent to participate in the study and are placed on the transplant list will be randomized into either the control or intervention group. The intervention group receives a personalized home exercise program along with weekly phone calls to provide coaching, mentoring and motivation. Data collected at baseline, post-transplant and, post-transplant follow up will be compared among the two study groups. The secondary outcomes include: normative data of functional measures for patients with end stage liver disease and to determine the effect size for future research on prehabilitation in the patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Being evaluated for liver transplantation by Barnes Jewish Hospital medical team

Exclusion Criteria:

• Non-english speaking

• Medical contraindications to exercise as determined by the medical team

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases
• Physical Activity

Intervention

Procedure:
• Exercise
Subjects will be given and individualized exercise program.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Barnes-Jewish Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a prehabilitation program.	Feasibility will be measured by participation and outcome assessment measures.	2 Years
Secondary	Normative data on Timed Up and Go for patients with end stage liver disease.		Baseline
Secondary	Normative data on 10 meter walk for patients with end stage liver disease.		Baseline
Secondary	Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.		Baseline
Secondary	Normative data on Five Time Sit to Stand for patients with end stage liver disease.		Baseline
Secondary	Normative data on 6 Minute Walk Test for patients with end stage liver disease.		Baseline