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

NCT ID: NCT02444273

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

Brief 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.

Conditions

End Stage Liver Disease; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Subjects will receive standard care both pre and post transplant.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise Group

Subjects will receive a personalized home exercise program and regular phone calls from a therapist to monitor and promote activity.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: PROCEDURE

Subjects will be given and individualized exercise program.

Interventions

Exercise

Subjects will be given and individualized exercise program.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Barnes-Jewish Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

201403118

Identifier Type: -

Identifier Source: org_study_id