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

NCT02444273 | Completed

• 1 other identifier: 201403118
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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

Keywords

liver diseases; liver transplantation; preoperative care; physical therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of a prehabilitation program.

  Feasibility will be measured by participation and outcome assessment measures.

  2 Years

Secondary Outcomes (5)

• Normative data on Timed Up and Go for patients with end stage liver disease.

  Baseline

• Normative data on 10 meter walk for patients with end stage liver disease.

  Baseline

• Normative data on Modified Dynamic Gait Index for patients with end stage liver disease.

  Baseline

• Normative data on Five Time Sit to Stand for patients with end stage liver disease.

  Baseline

• Normative data on 6 Minute Walk Test for patients with end stage liver disease.

  Baseline

Study Arms (2)

Control Group

NO INTERVENTION

Subjects will receive standard care both pre and post transplant.

Exercise Group

EXPERIMENTAL

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

Procedure: Exercise

Interventions

Exercise PROCEDURE

Subjects will be given and individualized exercise program.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-english speaking
• Medical contraindications to exercise as determined by the medical team

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator

MeSH Terms

Conditions

End Stage Liver Disease; Motor Activity; Liver Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: May 14, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05