NCT03106220

Brief Summary

Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
Last Updated

March 5, 2021

Status Verified

February 1, 2021

Enrollment Period

3.9 years

First QC Date

March 30, 2017

Last Update Submit

March 3, 2021

Conditions

SarcopeniaDebility Due to Disease

Outcome Measures

Primary Outcomes (2)

  • 6MWT

    6 minute walk

    3 months

  • hand grip

    hand grip

    3 months

Study Arms (2)

home exercise

ACTIVE COMPARATOR

participate in home exercise program

Behavioral: exercise

standard care

PLACEBO COMPARATOR

encouraged to join physical therapy and walking goals

Other: placebo

Interventions

exerciseBEHAVIORAL

home exercise program

home exercise
placeboOTHER

encourage walking and physical therapy per standard care.

standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kymberly D Watt

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: home exercise vs standard care with cross-over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 10, 2017

Study Start

March 1, 2017

Primary Completion

January 14, 2021

Study Completion

January 14, 2021

Last Updated

March 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)