Exercise Intervention - and Impact on Hospitalization

NCT ID: NCT03106220

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2021-01-14

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Debility Due to Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

home exercise vs standard care with cross-over
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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home exercise

participate in home exercise program

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

home exercise program

standard care

encouraged to join physical therapy and walking goals

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

encourage walking and physical therapy per standard care.

Interventions

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exercise

home exercise program

Intervention Type BEHAVIORAL

placebo

encourage walking and physical therapy per standard care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

inclusion= waitlisted for liver transplant with poor 6MWT

Exclusion criteria include: age \< 18 years, recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month, large esophageal varices without primary prophylaxis, active excessive alcohol intake (in the previous 3 months), current overt uncontrolled hepatic encephalopathy, hepatopulmonary syndrome with uncontrolled hypoxia, portopulmonary hypertension, inability to perform exercise, or marked symptomatic comorbidities (cardiac, pulmonary, renal). multiorgan transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kymberly D. Watt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kymberly D Watt

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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16-010102

Identifier Type: -

Identifier Source: org_study_id

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